Evaluation of Interdental Papilla Regeneration Using Injectable Hyaluronic Acid: A Clinical Study.

AIM: This study aimed to assess the efficacy of hyaluronic acid (HA) gel injections in deficient papillae and record the effects for four weeks. MATERIALS AND METHODS: Fifteen deficient class 1 papilla sites according to Nordland and Tarnow classification were included. After scaling and root planing, 0.5 ml HA gel was injected into the papillae. Measurements of black triangle height (BTH) and black triangle area (BTA) from the contact point to the most coronal level of the visible papilla tip were done on the clinical photographs using ImageJ software at baseline, one week, and four weeks postoperatively, and a comparison was made. Descriptive data were examined using the mean and standard deviation (SD). Paired t-test was used for intragroup comparisons, with p-values <0.05 considered significant. All the data analysis was done using SPSS software version 25.0. RESULTS: There was a mean decrease in the BTA from baseline (0.54 mm2), one week (0.13 mm2), to four weeks (0.26 mm2) with a slight loss of papilla volume from the first week to the fourthweek, and this decrease in area was statistically significant. A mean decrease in the BTH throughout the follow-ups from baseline (1.36 mm) to the first week (0.30 mm) to the fourth week (0.73) was recorded with a slight loss of papilla volume from the first week to the fourthweek, and this decrease in height was also statistically significant (p < 0.05). However, the decrease in the BTA and BTH recorded was more from baseline to the first week as compared to baseline to the fourth week postoperatively. CONCLUSION: HA gel is an effective treatment for minimally invasive papilla augmentation, particularly in class I Nordland and Tarnow papilla deficits.

Management of interdental papillary defects using subperiosteal hyaluronic acid injection overlay technique: a prospective longitudinal clinical study.

OBJECTIVE: Currently, there is no established treatment protocol to treat Interdental papillary loss. This research aimed to evaluate the outcomes of interdental papillary reconstruction using minimally invasive surgery, with injectable hyaluronic acid (HA) gel. MATERIALS AND METHODS: Seventeen patients were included, each with five sites of class 1 papillary recession; (forty sites in the upper jaw and forty-five sites in the lower jaw). Subperiosteal tunneling was performed through a horizontal incision made apical to the base of the papilla without penetrating it. The free gingival sulcus was sealed by 000 retraction cord. After that a total of 0.2-0.6 mL HA was injected gradually. The incision was sutured with polyglycolic sutures. Treated sites underwent clinical and digital evaluation at three follow up time points (1 month, 3 months and 6 months). RESULTS: The interdental papillary defect height in the upper jaw sites significantly reduced by 60%, 66%, and 42% at 1 month, 3 and 6 months, respectively. Also, in lower jaw sites, the reduction was of about 54%, 55%, and 40% at the same follow up time points. Regarding interdental papillary defect surface area in the upper jaw the reduction was about 65%, 71%, and 45% at 1 month, 3 and 6 months. In the lower jaw, a reduction of about 60%, 64%, and 48% was noticed at the same time points. Regarding patients' pain level score, during the day of surgery, sixteen patients reported pain, the average pain score out of 10 was 3.94, and eleven patients (64.7%) needed to take analgesics. The pain generally subsided in the following days. Also, at the day of the treatment twelve out of the seventeen patients (70.6%) reported mild difficulty in speaking and eating. No complication, hypersensitivity or allergy was noted in any patient. CONCLUSION: Subperiosteal tunneling with HA injection demonstrates clinical improvements in papilla height and papillary recession surface area reduction after 3 months of follow-up with reduction in improvement after 6 months.

Evaluation of advanced platelet-rich fibrin compared to subepithelial connective tissue graft in the surgical management of interdental papilla recession: a randomized controlled trial.

OBJECTIVES: The current study aims to compare advanced-platelet-rich fibrin membrane (A-PRF) to connective tissue graft (CTG) using Han and Takei's approach. MATERIALS AND METHODS: The defective papilla was randomly allocated to either the control group (CTG) or to the experimental group (A-PRF). Papilla height (PH) and percent change in the gingival black triangle (GBT) area were recorded at 1, 3, 6, 9, and 12 months. RESULTS: Thirty-two deficient IDPs with an initial papilla presence index (PPI) of 2 or 3 were included. At 12 months, the papilla-fill significantly increased in both groups (p < 0.001) without a significant difference between the study groups (p = 0.637). A mean gain in IDP height of 2.25 mm (± 0.97) in the CTG group and 1.86 mm (± 0.7) in the A-PRF group were recorded with a nonsignificant difference. Gingival black triangle fill showed a 57.98% fill in the CTG and 54.65% fill in the A-PRF group, with no statistically significant difference between the groups (0.956). Regarding postoperative pain patients, the CTG group consumed significantly more analgesics than the A-PRF group (11.75 ± 3.51 and 8 ± 3.08, respectively, with p = 0.003). CONCLUSION: Both CTG and A-PRF were found to be equally effective in increasing deficient IDP height with Han and Takei's surgical technique, with no significant difference. Within the current study's limitations, A-PRF seems to be a viable alternative to CTG in the treatment of GBTs. CLINICAL RELEVANCE: Multilayered A-PRF membrane can be used as a choice in the augmentation of receded papillae, using Han and Takei's technique.

Orthodontic tooth extrusion to regenerate missing papilla adjacent to maxillary anterior single implants: A 2- to 7-year retrospective study.

INTRODUCTION: Regeneration of the missing papilla adjacent to single implants in the esthetic zone has always been challenging, despite advances in vertical hard and soft tissue regeneration. Orthodontic tooth extrusion has been shown to effectively gain alveolar bone and gingival tissue. This retrospective study evaluated the effectiveness of orthodontic tooth extrusion on regenerating missing papilla between existing maxillary anterior single implant and its adjacent tooth. METHODS: Patients who underwent orthodontic tooth extrusion to regenerate missing papilla adjacent to a single implant in the esthetic zone were included in this study. The gingival phenotype, orthodontic extrusion movement, proximal bone level, dento-implant papilla level, facial gingival level, mucogingival junction level, and keratinized tissue width, of the extruded tooth were recorded at pre-orthodontic extrusion (T0 ), post-orthodontic extrusion and retention (T1 ), and latest follow-up (T2 ). RESULTS: A total of 17 maxillary single tooth had orthodontic tooth extrusion to regenerate missing papilla adjacent to 14 maxillary anterior single implants in 14 patients. After a mean follow-up time of 48.4 months, implant success rate was 100% (14/14), with none of the orthodontically extruded teeth being extracted. After a mean extrusion and retention period of 14.3 months, a mean orthodontic extrusion movement of 4.62 ± 0.78 mm was noted with a mean proximal bone level gain of 3.54 ± 0.61 mm (77.0% efficacy), dento-implant papilla level gain of 3.98 ± 0.81 mm (86.8% efficacy), and facial gingival tissue gain of 4.27 mm ± 0.55 mm (93.4% efficacy). A mean keratinized tissue width gain of 4.17 ± 0.49 mm with minimal mean mucogingival junction level change of 0.10 ± 0.30 mm were observed. The efficacy of orthodontic eruption movement on dento-implant papilla gain was less in the thin (80.5%) phenotype group when compared with that in the thick (91.5%) phenotype group. CONCLUSIONS: Within the confines of this study, orthodontic extrusion is an effective, noninvasive method in regenerating mid-term stable proximal bone and papilla adjacent to maxillary anterior single implants. CLINICAL SIGNIFICANCE: This retrospective study presents a mid-term result on orthodontic extrusion as a mean to regenerate dento-implant papilla defect. The extended retention period following orthodontic extrusion showed stable and efficacious proximal bone and papilla gain.

Restoring black triangle with bioclear matrix versus conventional celluloid matrix method: a randomized clinical trial.

BACKGROUND: Open gingival embrasures form complex aesthetic and functional problems. This clinical trial assessed the bioclear matrix using injection molding technique against conventional celluloid matrix technique in management of black triangle. METHODS: A total of 26 participants were randomly divided into two groups (13 participants each) according to the technique used. In group (A) celluloid conventional matrix method was used, while in group (B) bioclear matrix with injection molding technique was used. The different outcomes (Esthetic evaluation, marginal integrity and patient satisfaction) were evaluated following the FDI criteria by two blinded examiners. The evaluation was done at (T0) (immediate after restoration); (T6) after 6 months; and (T12) after 12 months. Statistical analysis was done as categorical and ordinal data were presented as frequency and percentage values. Categorical data were compared using fisher's exact test. Intergroup comparisons for ordinal data were analyzed utilizing the Mann-Whitney U test, while intragroup comparisons were analyzed using Friedman's test followed by the Nemenyi post hoc test. The significance level was set at p ≤ 0.05 within all tests. RESULTS: Regarding radiographic marginal integrity and marginal adaptation, the bioclear matrix group revealed superior results when compared to celluloid matrix group with a significant difference between both groups at all intervals (p < 0.05); however no significant difference was detected at different intervals. While for proximal anatomical form and esthetic anatomical form, as well as phonetics and food impaction, all cases in both groups were successful with no statistical significant difference between groups. For the periodontal response, there was no significant difference between groups. However, there was a significant difference between scores measured at different intervals, with T0 being significantly different from other intervals (p < 0.001). Marginal staining revealed that there was no significant difference between groups. While, a significant difference between scores measured at different intervals. CONCLUSIONS: The restorative management of the black triangle with both protocols was able to deliver superior aesthetic and good marginal adaptation; suitable biological properties; with adequate survival time. Both techniques were almost equally successful, however they are depending on the operator skills. TRIAL REGISTRATION: The clinical trial was registered in the ( www. CLINICALTRIALS: gov/ ) database in 23/07/2020; with the unique identification number NCT04482790.

Interdental Papillary Reconstruction by Microtunnelling Technique Using Autologous Biomatrices-A Randomised Controlled Clinical Trial.

Background and objectives: The study aimed to evaluate and compare the amount of papillary gain and black triangle height reduction after intervention with a microtunnelling technique with either Connective tissue graft (CTG) or Platelet-rich fibrin (PRF) as a biomatrix at 6 months using a microsurgical approach. Materials and Methods: Twenty-six patients with interdental papillary loss were included in the study. The patients were selected randomly for the study groups with thirteen patients in each group: a control group where CTG was utilised as a matrix, and a test group where PRF was utilised as a matrix, for interdental papillary reconstruction. A microtunnelling technique was performed for both the study groups under a surgical microscope. The primary parameters assessed were interdental Papillary height (PH) and Black triangle height (BTH) at baseline, with secondary parameters Visual analogue score by dentist (VAS-D) and patient (VAS-P) assessed at 6 months. Results: Both the control and test groups showed a significant reduction in BTH within their respective group at six months (p < 0.05). The gain in papillary height significantly improved only in the CTG group at 6 months. However, significant differences could not be demonstrated for any of the variables such as BTH (p value = 0.582) and PH (p-value = 0.892) between the study groups at 6 months. Conclusions: IDP reconstruction utilising a microtunnelling approach with CTG or PRF was successful without any significant differences between the groups for the parameters assessed at 6 months.

Incidence of Gingival Black Triangles following Treatment with Fixed Orthodontic Appliance: A Systematic Review.

This systematic review aimed to investigate the relation between orthodontic treatment (OT) and the incidence of the gingival black triangle (GBT) after completing treatment with a fixed orthodontic appliance, as well as the associated risk factors and the level of alveolar bone. Electronic and hand searches were conducted in three electronic databases for relevant articles published up to March 2022. Retrieved articles went through a two-step screening procedure, and the risk of bias (RoB) was assessed by the Joanna Briggs Institute checklists. The incidence of GBT after OT was set as the primary outcome, while the secondary outcomes were the risk factors associated with GBT and alveolar bone loss following OT. Out of 421 papers, 5 were selected for the final analysis. The RoBs of three studies were moderate and the remaining two were low. The incidence of GBT following OT ranged from 38% to 58%. In addition, three studies reported that alveolar bone loss was reduced significantly following OT and associated with GBT, while one study found the opposite. Regarding the risk factors associated with GBT, the reported results attributed GBT to several factors including age, tooth-related factors, treatment duration, and soft tissue factors. The analysis indicates an increased incidence of GBT following OT; however, a firm conclusion cannot be drawn. Additionally, it was not possible to reach a consensus on risk factors associated with GBT due to the heterogeneity of the data. Therefore, further randomized clinical trials are highly recommended to draw a firm conclusion.

Efficacy of concentrated growth factor with low-level laser for the regeneration of interdental papilla defects.

Gingival "black triangle" is common in clinical which due to interdental papilla recession. The cause of the loss of papilla is multi-factorial and it may be caused by the absorption of interdental alveolar bone or abnormal tooth position. Besides, it is a common complication after orthodontics and implant surgery. Recession of gingival papilla influences interdental plaque control, increasing food impaction and alveolar bone absorption, causing aesthetic and pronunciation problems. Thus, the way of reducing or eliminating the gingival "black triangle" has become one of the most essential problems for dentists. Concentrated growth factor (CGF) and low-level-laser therapy have been widely used, respectively, and CGF was considered as the only self-substance which has soft tissue regeneration function. This study aims to evaluate the efficacy of regenerating interdental papilla by Liquid phase concentrated growth factor (LPCGF) injection with low-level-laser therapy (LLLT).

Regulation Awareness and Experience of Additional Monitoring among Healthcare Professionals in Finland.

BACKGROUND: Challenges in post-marketing adverse event reporting are generally recognized. To enhance reporting, the concept of additional monitoring was introduced in 2012. Additional monitoring aims to enhance reporting of adverse events (AE) for medicines for which the clinical evidence base is less well developed. PURPOSE: The purpose was to get a deeper understanding of the underlying reasons why additional monitoring has not increased AE reporting as much as initially hoped. We examined how healthcare professionals (HCPs) in Finland perceive additional monitoring, why they do or do not report AEs more readily for these medicines and how they interact with patients treated with additionally monitored medicines. METHODS: An anonymous, open questionnaire was developed and made available online at the e-form portal of University of Helsinki. Physicians, nurses, and pharmacists were invited to complete the questionnaire via their respective trade or area unions. Content analysis of answers to open-ended questions was performed by two independent coders. RESULTS: Pharmacists have the best understanding about additional monitoring but at the same time do not recognize their role in enhancing monitoring. Only 40% of HCPs working with patients knows always or often if a specific medicine is additionally monitored. Half (53%) of HCPs do not tell or tell only rarely patients about additional monitoring. 18% of HCPs reported having received additional monitoring training whereas 29% had received general AE reporting training. AE reporting was more common among HCPs who had received training. CONCLUSIONS: Additional monitoring awareness among HCPs and patients should be increased by organizing regular educational events and making additional monitoring more visible. Educational events should emphasize the significance additional monitoring has on patient safety and promote a reporting culture among HCPs.

Hyaluronic acid vs. physiological saline for enlarging deficient gingival papillae: a randomized controlled clinical trial and an in vitro study.

BACKGROUND: loss of the interdental papillae leads to the formation of a black triangle, which compromises smile esthetics and contributes to food impaction and plaque accumulation. The aim of this study was to evaluate the efficacy of the injection of hyaluronic acid (HA) and compare it to that of physiological saline solution in the restoration of deficient gingival papillae in vivo and in vitro. METHODS: Twenty-four patients with 68 deficient gingival papillae were recruited for this clinical trial with a split-mouth design. The deficient gingival papillae on one side of the anterior maxilla were injected with HA, and those on the other side were injected with physiological saline solution. The heights of the gingival papillae and the areas of the black triangles were measured from clinical photographs obtained before and 6 and 12 months after treatment. Additionally, the proliferation and migration of gingival fibroblasts were evaluated after HA and physiological saline treatment by an in vitro study. RESULTS: the results revealed that the injection of HA yielded 0.198 and 0.28 mm gingival papilla increasement at 6 and 12 months, respectively, relative to the baseline (P<0.05). However, deficient gingival papillae also grew by 0.278 mm at 12 months in the group that received physiological saline solution (P<0.05). The injection of HA significantly improved deficient gingival papillae 6 months earlier than the injection of physiological saline solution. HA also significantly accelerated the proliferation and migration of gingival fibroblasts in vitro. CONCLUSIONS: The present study confirms that the injection of HA could increase the height of gingival papillae for improving gingival papilla defects. However, the effect is not superior to that of physiological saline solution. This trial was registered in the Chinese Clinical Trial Registry (ChiCTR-ONC-17011781) (28/06/2017). http://www.chictr.org.cn/showproj.aspx?proj=19931.

[Stripping: contribution to the control of iatrogenic periodontal effects]. / Réduction amélaire proximale : apport au contrôle des effets iatrogènes parodontaux.

The gum and the gingival festoon in particular are essential elements of the good periodontal health and the harmony of the smile. How does this engage orthodontics? Orthodontists are directly concerned by the vertical position of the collars which they must consider. More indirectly, they can have an influence on the gum festoon and in particular on the papillae. The analysis of the literature of the undesirable effects of orthodontics on the periodontium is provided but with limited conclusions which do not constitute scientific evidence. It remains very important to analyze them in order to draw a guide of clinical conduct. The vestibular version and the alveolar expansion present risks of gingival recession that must be taken into account. The presence of the papillae responds to precise anatomical conditions that have to be controlled to avoid disastrous black triangles when aligning the teeth. The shape of the teeth is directly involved in these phenomena. Stripping may be an appropriate therapeutic response to prevent or limit these iatrogenic effects. The approach is first of all diagnostic (identification of the shape of the teeth, analysis of the dento-dental disharmony (DDD), evaluation of the amount of stripping and its consequences on the DDD) and then prognostic in order to establish the treatment plan... The author will illustrate this approach by the teachings of the literature and by clinical illustrations of treated cases. The balance of a smile is based on the respect of shapes, anatomical proportions and the conditions necessary for healthy tissue. It is our role to respect them in the project of establishing harmony. The beauty of the smile reflects the patient's own personality: « Orthodontists are the technicians of the semaphore of the soul ¼, Axel Kahn, Journées de l'Orthodontie, 2007.

What are the patients' and health care professionals' understanding and behaviors towards adverse drug reaction reporting and additional monitoring?

BACKGROUND: The additional monitoring (AM)/black triangle concept is aimed to enhance ADR reporting for certain types of medicinal products for which the safety profile is less well established. PURPOSE: The objective of this survey was to assess (a) attitudes towards ADR reporting and reasons for not reporting an ADR and (b) awareness of AM among HCPs, patients or their careers in EU countries. METHODS: An online questionnaire which was available in all EU languages was completed by 2918 responders coming from all EEA countries. RESULTS: The main factors motivating to report an ADR were severity or novelty of the reaction or novelty of the medicine. The main factors for not reporting an ADR was the fact that the ADR is already known (35%), the ADR was not serious (18%) or reporter was not sure if the ADR was related to the medicine (15%). Half of the respondents indicated that they have seen AM statement before. Thirty percent of the responders had correct understanding of the AM concept while 20 % misunderstood the concept. CONCLUSION: Underreporting occurs but it seems this is because of reporter's prioritisation towards certain type of ADRs. AM aims to increase reporting for certain medicines, however, approximately half of responders have seen the AM symbol before and 20% of all responders (independent of their previous awareness) misunderstood the concept.

[The teeth shape. An essential element of the diagnosis]. / La forme des dents. Un élément incontournable du diagnostic.

Form is often linked to function. This applies particularly to teeth; the phylogenesis of our dentition shows that the dental formula was established long before Homo sapiens. Today, the shape of teeth has several roles: chewing, aesthetics and periodontal balance. The analysis of the literature shows the importance of shapes, particularly in the periodontal equilibrium. Diagnostic analysis of the shapes enables us to detect those that are said to be at risk and to prevent iatrogenic effects due to dental alignment. By applying this shape analysis to clinical examples, we will show the interest of this approach in the treatment of dental-maxillary disharmony, in the prevention of the loss of papillae associated with the opening of black triangles and the aesthetic improvement of shapes. The characterization of tooth shapes is an essential diagnostic element for a safer and more harmonious orthodontic treatment.

Interproximal Papilla Volumization Using Vestibular Incision Subperiosteal Tunneling Access Technique in Esthetic Rehabilitation.

An accurate diagnostic and interdisciplinary approach is essential for obtaining suitable, conservative, and predictable results in areas with high esthetic demand. Patients reporting with an improper prosthesis that has a black triangle pose a challenge for soft-tissue esthetic rehabilitation. Re-restoration of such cases with conventional fixed prosthesis would be undesirable due to imbalance in pink and white esthetics. This case report describes an interdisciplinary approach to maintain the existing midline diastema and correction of black triangle in the interproximal area between abutment and pontic in the esthetic zone. Minimally invasive vestibular incision subperiosteal tunneling access technique with connective tissue graft was planned for reconstructing the interdental papilla, followed by prosthetic rehabilitation of edentulous site with fixed partial denture using loop connector design to maintain the midline diastema. Postoperative result showed a comprehensive, pink and white rehabilitation to meet the patient's esthetic demand.

Effect of Hyaluronic Acid Filler Injection on the Interdental Papilla in a Mouse Model of Open Gingival Embrasure.

The black triangle resulting from interdental papilla (IDP) loss is associated with poor aesthetics and difficulty in pronunciation and food impaction. There is limited knowledge of gingival tissue inflammatory response to hyaluronic acid (HA) filler injection, a minimally invasive IDP reconstruction method. This study aimed to examine the morphological and histological changes in IDP and the inflammatory cytokine localization to the IDP post-HA filler injection using an open gingival embrasure (OGE) mouse model. Mice from the control, sham, and OGE groups were attached with reference, inactive, and activated wires for 5 days, respectively. The degree of IDP loss was determined based on the spring-papilla distance (SPD). Morphological and histological changes in the OGE group injected with phosphate-buffered saline (PBS) or HA fillers were examined on days 2 and 7 post-injection. Immunohistochemical analysis was performed to determine the localization patterns of tumor necrosis factor (TNF)-α, interleukin (IL)-1ß, IL-6, myeloperoxidase (MPO), and Ki67. Five days post-wire attachment, the control and OGE groups exhibited a significantly higher SPD than the sham group (p < 0.0167). The SPD of the HA filler injection group was significantly lower than that of the PBS injection group on days 2, 4, and 7 post-injection (p < 0.05). The IDP of the OGE group was wide and flat. HA filler was stable in the connective tissue underlying the epithelial tissue even on day 7 post-injection. TNF-α, IL-1ß, IL-6, MPO, and Ki67 were highly localized to the connective tissue surrounding the filler on day 2, which decreased on day 7 post-injection. Thus, HA filler can safely and successfully reconstruct the IDP in cases of OGE.

Effect of the black triangle scheme and its online educational campaign on the quantity and quality of adverse drug event reporting in Australia: a time series analysis.

OBJECTIVES: The black triangle scheme was introduced to Australia in January 2018 to improve the significant under-reporting of adverse drug events (ADEs). The authors investigated the impact of the black triangle scheme on the quantity and quality of ADE reports submitted to the Therapeutic Goods Administration. METHODS: An interrupted time series analysis with segmented regression was conducted to compare the quantity of ADE reports pre and post the black triangle intervention for the period between January 2017 and December 2018. The quality of reports was measured by the ability to apply the World Health Organization - Uppsala Monitoring Center algorithm to evaluate a causal relationship between the medicine and ADE. RESULTS: A total of 384 ADE reports were extracted for the 33 medicines approved in 2017 and 135 ADE reports for the 36 black triangle medicines. Time series analysis showed that there was a monthly increase of 0.41 reports per medicine (95%CI, 0.02-0.80, p = 0.039) post the black triangle intervention. There was a higher proportion for high quality reports for black triangle medicines versus 2017 medicines (22.2% vs 7.6%, p < 0.001). CONCLUSION: The black triangle scheme was marginally successful in improving ADE reporting and additional strategies are required to enhance the overall pharmacovigilance system in Australia.

Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada.

Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product. However, such prescriptions are carried out in a controlled manner. Prior to being approved, the medicinal product will have been evaluated in a population pool containing fewer than 5,000 patients and in a predesigned environment where several factors may be lacking, such as the absence of women of childbearing potential, geriatric patients and paediatric patients. Therefore, it is not surprising that several major adverse drug reactions are detected only when the product has been prescribed to the general population. National and international regulatory bodies have devised systems for monitoring medicinal products after marketing, commonly known as postmarketing surveillance systems. Postmarketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the successful completion of clinical trials. The primary purpose for conducting postmarketing surveillance is to identify previously unrecognized adverse effects as well as positive effects. The Yellow Card scheme, practiced in the United Kingdom and the Canada Vigilance Program adopted in the Canadian jurisdiction, are two of the most successful postmarketing surveillance systems implemented across the world. Therefore, this article intends to discuss postmarketing surveillance and its role in the context of the United Kingdom and Canadian jurisdictions with a view on presenting key aspects and measures that are employed for operating an efficient postmarketing surveillance system in regulated markets.

Belgian community pharmacists' pharmacovigilance perspective and practice.

BACKGROUND: Pharmacovigilance legislation was introduced back in 2012 with new concepts such as the inverted black triangles and risk minimisation activities. Healthcare professionals need to familiarize themselves with these new notions in order to comply with their obligations such as risk mitigation and reporting of adverse drug reactions. OBJECTIVE: To measure the magnitude and relevance of these new concepts and the impact on everyday dispensing in Belgian community pharmacies. METHODS: An inventory database was constructed containing all relevant pharmacovigilance information at product level, and this data was made available within the pharmacy dispensing software. Furthermore, for a typical community pharmacy, the number of concerned products and the number of dispensed products with supplementary pharmacovigilance responsibilities was determined. RESULTS: The number of available and dispensed medicines with black triangle or additional risk minimisation activities has increased significantly since July 2014. During July 2017, each pharmacy dispensed around 120 packs with risk minimisation obligations and around 70 with a black triangle, clearly illustrating the relevance of having all information at hand. CONCLUSIONS: With relevant safety information available at the point of dispensing, pharmacists can now focus on complying with their pharmacovigilance responsibilities.

Risk factors associated with open gingival embrasures after orthodontic treatment.

OBJECTIVES: To investigate the incidence of and contributing factors to open gingival embrasures between the central incisors after orthodontic treatment. MATERIALS AND METHODS: One hundred posttreatment patients (29 men and 71 women; mean age, 24.7 years) were divided retrospectively into occurrence and nonoccurrence groups based on intraoral photographs. Based on the severity, the occurrence group was further divided into mild, moderate, and severe groups. Parameters from periapical radiographs, superimposed lateral cephalograms, and study models were compared between the occurrence and the nonoccurrence groups by using independent t-tests and were also analyzed on the basis of severity via analysis of variance. Logistic regression analysis was performed to identify the contributing factors to open gingival embrasures. RESULTS: The incidence of open gingival embrasures between the central incisors was 22% and 36% in the maxilla and the mandible, respectively. Lingual movement of the incisors, distance from the contact point to the alveolar crest after treatment, antero-posterior overlap of the two central incisors before treatment in the maxilla, and distance from the contact point to the alveolar crest after treatment in the mandible were significantly associated with the occurrence of open gingival embrasures ( P < .05). In the mandible, the amount of intrusion was significantly related to severity ( P < .05). CONCLUSIONS: The incidence of open gingival embrasures following orthodontic tooth movement is high. Therefore, attention should be paid to the contributing factors to prevent or reduce the occurrence of open gingival embrasures.

Research progress on the gingival papilla reconstruction / 口腔疾病防治

@#The morphology of the gingival papilla plays an important role in the aesthetics of oral soft tissue. Gingival papilla recession forms a visible black triangle, causing a series of problems such as aesthetic defects, pronunciation disorders and food impaction and even endangering the health of periodontal tissue. Gingival papilla reconstruction is an effective way to eliminate the black triangle. However, the treatment of lost or collapsed gingival papilla is unsuccessful. Reconstruction of the interdental papilla for aesthetics zone is the most difficult and challenging periodontal treatment. In this article, we review the past literature and summarize the factors affecting the appearance of gingival papilla, including the distance between the contact point and the alveolar crest, the distance between roots, divergent roots, interdental width, embrasure morphology, crown shape, and gingival biotype. The classification of the gingival papilla based on the loss of papillary height and the nonsurgical and surgical methods for the reconstruction of gingival papilla are reviewed to provide a reference for doctors to reconstruct the gingival papilla.