Evaluation of safety and efficacy of locally developed dental implants: A noninferiority randomized controlled trial.

STATEMENT OF PROBLEM: Various dental implants are available in India, but imported devices are expensive; an affordable locally produced dental implant system would be beneficial. PURPOSE: The purpose of this noninferiority randomized controlled trial was to compare the safety and efficacy of a locally developed dental implant system to those of an established imported dental implant system with similar microsurface characteristics. MATERIAL AND METHODS: A total of 136 participants with 201 partially edentulous sites, aged 18 to 65 years, were enrolled in the trial, with 134 sites receiving test implants and 67 sites control implants (n ratio, 2:1). The implants received a delayed submerged healing protocol and were loaded 3 to 6 months after surgery. Maximum insertion torque (IT) was recorded during the implant surgery, and the implant stability quotient (ISQ) was evaluated on the day of surgery and at the second-stage procedure. The mean crestal bone loss (MCBL) was measured on periapical radiographs at prosthetic placement (baseline) and at 6 months and 12 months after loading. The primary measure of outcome was the implant survival rate, and the secondary measure of evaluation was the intergroup difference in MCBL at baseline, 6 months, and 12 months. RESULTS: A total of 127 test and 61 control implant sites were available for follow-up 1 year after prosthesis placement. At the end of 12 months, the test and control implant groups demonstrated a survival rate of 97% and 100%, respectively. The MCBL difference was significant between the 2 groups at baseline (P<.05). However, at 6 and 12 months, the difference between the test and control groups was not significantly different (P>.05). CONCLUSIONS: The survival rate of the test group fell within the previously assumed 10% noninferiority margin. Therefore, the null hypothesis was accepted for the trial, and the locally developed implants were noninferior to the imported implants at a sample allocation ratio of 2:1.

Cranioplast fabrication in a comatose patient: A clinical report.

Cranioplasty may be necessary after decompressive craniectomies to aid in the restoration of the esthetic, morphological, functional, and psychosocial stability of those affected. This clinical report describes the management of a comatose road traffic accident victim with a history of autogenous cranial implant failure after decompressive craniectomy. The challenges posed by the nonambulatory state of the patient and his inability to follow commands were overcome by using reverse engineering and rapid prototyping to fabricate a 3D patient-specific polymethylmethacrylate cranial implant. A digital evaluation technique with grids as measuring tools was successfully implemented in the patient's absence. The use of a custom clamp flask aided in the accommodation and subsequent investing, dewaxing, and polymerization of the carved cranial wax pattern. As a result, a custom cranioplast with optimum marginal fit, acceptable contour, adequate thickness, and reduced surgical duration of placement was obtained through a successful combination of conventional and digital techniques.

Assessment of Treatment Outcome of Presurgical Nasoalveolar Molding in Patients With Cleft Lip and Palate and Its Postsurgical Stability.

OBJECTIVE: To analyze the effects of presurgical nasoalveolar molding (PNAM) in newborns with cleft lip and palate and evaluate its postsurgical stability at 1-year follow-up using a nasal stent. DESIGN: Prospective clinical trial. SETTING: Department of Orthodontics, Maulana Azad Institute of Dental Sciences, Delhi. PATIENTS: Patients with cleft lip and palate of 0 to 6 months. Sample size 25 recruited, 16 satisfactorily completed the procedure. INTERVENTIONS: Presurgical nasoalveolar molding done as indicated in all the patients. Postsurgical external nasal stents were given for 1 year to maintain the nasal correction. MAIN OUTCOME MEASURES: Changes in cleft defect and maxillary arch were recorded pre- and post-PNAM. Changes in nasal morphological parameters assessed pre- and post-PNAM and 1 year after surgical repair following the use of nasal stent. RESULTS: There was a significant reduction in cleft defect assessed both intraorally ( 4.16 mm) and extra orally ( 4.42 mm) at the end of PNAM therapy (average treatment time 4 months). The nasal morphology improved with an increase in columella height (1.5 mm) and reduction in columella width. Bialar width reduced (2.90 mm) with an increase in nostril height ( 2.10 mm). Better symmetry was achieved in all cases as the nostril height and width difference changed significantly pre- and post-nasoalveolar molding. The percentage increase in columella height was greater for infants less than 6 weeks. CONCLUSIONS: Presurgical nasoalveolar molding considerably reduces the cleft gap and improves arch form making surgical union easier along with improved nasal morphology which can be maintained at 1-year postsurgery by use of a postsurgical external nasal stent.

Role and influence of growth factors on early osseointegration in animal jaw bone: A meta-analysis.

AIM: Growth factors (GFs) are polypeptides, which are intricately involved in the regulation of bone formation, preservation, and regeneration through gene expression. However, the role of these bioactive agents in osseointegration of dental implants has not been substantially proven. The objective of this systematic review (SR) and meta-analysis was to explore the effect of GFs on early osseointegration of dental implants in animal jaws. An attempt to decipher an adjunctive role of GFs in modulating predictable bone growth in peri-implant areas was done. MATERIALS AND METHODS: An electronic and manual search of different databases was performed. Only randomized controlled trials (RCTs) were included and reviewed. The risk of bias (ROB) of the selected studies was assessed using the SR Centre for Laboratory Animal Experimentation (Cochrane) tool. A meta-analysis was also performed to evaluate the different study characteristics quantitatively. STATISTICAL ANALYSIS USED: The total Weighted mean difference was evaluated using the Rev-Manv5.3 algorithm. Chi-square test and I2 test were done to assess the heterogeneity between the studies. RESULTS: Seven RCTs were included in the study. These were associated with a high ROB. The total weighted mean difference (WMD) of the percentage of bone-implant contact was 3.25% (95% confidence interval [CI] = 1.49%-6.03%; P = 0.001; I2 = 91%) between groups with and without exogenous application of GFs. The total WMD of the percentage of newly formed bone area was 4.48% (95% CI = 2.31%-5.90%; P < 0.00001, I2 = 84%). A high level of heterogeneity (P < 0.001 for Chi-square test; I 2>50 %) among comparable studies was observed. CONCLUSION: The ancillary application of external GFs exhibited evidence of early osseointegration, resulting in more predictable and faster results. However, a careful discernment of conclusions drawn from this SR is a must before conducting any human trials.

Association between periodontal disease and gestational diabetes mellitus-A prospective cohort study.

AIM: This study aimed to determine the association between periodontal disease and gestational diabetes mellitus (GDM) and the effect of this association on pregnancy outcome in North Indian population. MATERIALS AND METHODS: A total of 584 primigravidae were recruited at 12-14 weeks of gestation. Their periodontal examination was carried out along with 75 g oral glucose load test at the time of recruitment. GDM was diagnosed as per the DIPSI (The Diabetes in Pregnancy Study group India) guidelines (≥140 mg/dl). Women with normal plasma glucose values underwent a repeat 75 g oral glucose load test at 24-28 weeks of gestation. All patients were followed up for pregnancy outcomes. RESULTS: Of 584 primigravida, 184 (31.5%) had gingivitis and 148 (25.3%) had periodontitis. Overall, 332 (56.8%) pregnant women had periodontal disease. It was associated with GDM with adjusted hazard ratio (aHR) of 2.85 (95%CI = 1.47-5.53). The occurrence of pre-eclampsia was associated with periodontal disease with aHR of 2.20 (95%CI = 0.86-5.60). If primigravidae had periodontal disease along with GDM, the risk of pre-eclampsia had shown increased aHR of 18.79 (95% CI = 7.45-47.40). CONCLUSIONS: The study shows a significant association of periodontal disease with GDM and an increased risk of developing pre-eclampsia due to this association.

Fibular Graft-Effective Panorama for Prosthetic Rehabilitation of Resected Mandible.

Surgical management of extensive tumors in the mandibular region leads to massive disfigurement of the face. Also the prosthetic outcome of such patients rehabilitated with free soft tissue flaps is very poor. Reconstruction of extensive defects to overcome the disfigurement is a challenging procedure and can be achieved with free fibula flap. Free fibula graft provides sufficient length of bone for the reconstruction of the postsurgical defects. Excellent vascularity of fibula flap allows for easy uptake of the graft and osseointegration of the dental implants. The addition of a skin island allows for absolute tension-free intraoral closure that enhances tongue mobility. Fibula graft allows proper tissue support after mandibular reconstruction. After rehabilitation with free fibula graft we can plan for prosthodontic rehabilitation with implant retained prosthesis leading to improved masticatory function. It also helps to improve speech outcome as a stable prosthesis can be delivered with the help of implants retained in the fibula graft. It is essential to assess the outcome of surgical reconstruction with fibula graft followed by prosthetic rehabilitation with implant retained prosthesis for their recognition as a treatment of preference. This article details the clinical report along with various clinical parameters for implant retained prosthetic rehabilitation of the patient who had undergone mandibular resection and reconstruction with free fibula graft.

Cameo surface recording in complete denture fabrication using transcutaneous electrical nerve stimulation: A clinical report.

Severe bone loss in patients with complete edentulism poses a treatment challenge. In fabricating a denture, the stability of the prosthesis must be enhanced by recording the cameo surface within the confines of the physiological position of the cheek and tongue muscles (the neutral zone) and by shaping it accordingly. The treatment of a patient with a completely edentulous maxillary arch and severe maxillary anterior bone loss is described. The cameo surface was recorded within the physiological limits during the fabrication of a complete denture by using transcutaneous electrical nerve stimulation (TENS).

Validation of ICMR index for identification of dental fluorosis in epidemiological studies.

BACKGROUND & OBJECTIVES: The Indian Council of Medical Research (ICMR) formulated a Task Force on dental fluorosis and recommended the subgroup to develop a simplified index for identification and grading of dental fluorosis to be used by the health workers. This study was conducted to pre-test the 'ICMR Index for Dental Fluorosis' in the field to check its reliability and reproducibility. METHODS: A total of 600 photographs were taken, 150 in each grade of fluorosis by screening 14-17 yr school children from eight schools of Hisar (Haryana) and South west Delhi. Eighty photographs were finalized (20 in each grade) before calibration to be used for training of field workers. Calibration exercise was conducted involving the five member survey team on 100 diagnosed cases of dental fluorosis. The members again screened 74 children with dental fluorosis in the field to categorize in to different grades of fluorosis for assessment of inter-examiner reliability. RESULTS: The ICMR criteria showed more difference in agreement in very mild and mild categories during calibration. The inter-examiner reliability (κ) ranged from 0.59-1. The criteria was further modified and inter- examiner reliability (κ) found to be 0.83-0.98 which was almost perfect agreement. INTERPRETATION & CONCLUSIONS: The tool developed by the ICMR to assess dental fluorosis can be used in a field set up by non-dental personnel reliably with high degree of reproducibility.

Technique for adapting a spacer for a custom impression tray.

A method of adapting a spacer for the custom trays used to make a definite impression for complete dentures is presented. The technique can be used under a variety of conditions and offers several advantages.

Correction of microstomia in an edentulous patient.

The problem of small oral aperture is big. Irrespective of the etiology, this problem may be overcome by adjunctive therapies in the form of prosthesis, surgery, or exercise. A patient is described with this problem, which was overcome by revisiting the 3 adjunctive therapies including a commissural stent designed with the patient's edentulous state in mind.

Correction of cheek biting in a dentate patient.

Postsurgical injury by teeth to oral mucosa (reconstructed by a flap) can lead to ulceration and subsequent infection at the reconstructed site. A prompt intervention by fabricating a specially designed prosthesis to deflect the reconstruction flap away from the occluding teeth has been described for the treatment of cheek biting in the present clinical report.

Mini-Implants, Mega Solutions: A Case Series.

Dental implants have evolved as a standard of care for replacement of missing teeth. Though this treatment modality promises a high level of patient satisfaction and success, it cannot be performed in all cases. Apart from medically compromised patients, implant use is also restricted whenever there is limited available bone volume at the edentulous site. An example includes the mandibular incisor, the maxillary lateral incisor region, and other sites with reduced interdental spacing and atrophic edentulous maxillary and mandibular ridges. Bone volume at some of these sites can be increased by suitable augmentation procedure for placement of a regular diameter implant (3.75 to 4.2 mm). But many a times such procedure cannot be undertaken either due to financial constraint, risk of subjecting the patient to additional surgical procedure, added time factor, or guarded prognosis of the grafted site. In such cases, mini-implants can be used. In this case series, mini-implants (2.5 to 3 mm) were used to replace teeth in all mouth quadrants and to retain a mandibular overdenture in a compromised case. The implants served well at all the sites with minimal bone loss and a high level of patient satisfaction. Mini-implants hold the potential to serve as an alternate to regular diameter implants in certain situations. Preferably they should be used in multiples to retain fixed dental prostheses and might serve as an efficient, low-cost solution for retaining overdentures in selected cases.

Rehabilitation of resorbed mandibular ridges using mini implant retained overdentures: A case series with 3 year follow-up.

With the increasing average life expectancy of human beings, the need to cater geriatric patients is ever increasing. Complete dentures are an indispensable tool in this regard. The loose and unstable lower complete denture owing to residual ridge resorption is one of the most common problems faced by edentulous patients. Dental implant retained overdentures have emerged as an efficient treatment modality for such patients. Though useful, not every patient is a suitable candidate to go for conventional implant-borne prosthesis, limitation being the available bone width. In such cases, mini implants may be used for augmenting the retention of the dentures and improving the quality of life of patients. In this case series, rehabilitation of three compromised cases with mini implant retained overdentures have been described wherein patients are experiencing instability of lower denture due to thin resorbed mandibular ridges. In one of the cases, three mini implants placed in A, C, and E position were splinted using a cemented bar to retain the mandibular denture. The other two cases were rehabilitated using unsplinted ball type one piece mini implants placed in A, C, and E position in one case and B and D position in another case. Though splinted bar design should be preferred but the lack of available vertical space precluded the utilization of bar in other two cases. The results were found to be satisfactory with no complications reported during a follow-up period of over 3 years in all the cases.

An Alternate Vista in Rehabilitation of Cranial Defects: Combining Digital and Manual Techniques to Fabricate a Hybrid Cranioplast.

The desired features of a cranioplast include providing an acceptable contour, continuity with the remaining skull (marginal adaptation), improvising the aesthetic outcome, providing a strengthened prosthesis to avoid fracture in case of repeat trauma, and protecting the remaining neurological structures. Combining digital and manual techniques to fabricate a hybrid polymethylmethacrylate cranioplast during the rehabilitation of a pediatric patient with cranial defect has been described. Utilization of digital techniques (rapid prototyping to obtain skull analog) and manual (hand) sculpting of the prosthesis strengthened with glass fiber enabled the authors to fabricate a hybrid cranioplast. Satisfactory outcome was achieved.

Novel use of platelet-rich fibrin matrix and MTA as an apical barrier in the management of a failed revascularization case.

METHOD: We report management of a failed revascularization/revitalization case, which could be due to inadequate removal of biofilm and bacteria in dentinal tubules. The use of an apical matrix barrier in form of a platelet-rich fibrin (PRF) membrane for stabilization of MTA in root end apexification procedure is described. The canal was cleansed of old MTA present in the cervical third using H files, irrigated using saline and finally irrigated with 2.5% NaOCl and saline. To obtain canal disinfection, calcium hydroxide paste was temporized in the canal. In subsequent appointments, PRF was placed at the root tip followed by 5-mm apical plug with mineral trioxide aggregate. One week later, the root canal was obturated with thermoplasticized gutta-percha. A 6-month and a 2-year follow ups showed reduction of periapical radiolucency and adequately functional tooth. RESULTS: One-visit apexification techniques provide an alternative treatment for failed revascularization cases. Follow up confirmed complete healing periradicularly. CONCLUSION: Apexification in one step using an apical barrier of PRF and a plug of MTA can be considered a predictable treatment and may be an alternative to long-term revascularization failures.

Comparative evaluation of surface topography of tooth prepared using erbium, chromium: Yttrium, scandium, gallium, garnet laser and bur and its clinical implications.

BACKGROUND: Erbium, chromium: Yttrium, scandium, gallium, garnet (Er, Cr: YSGG) laser has been successfully used in the ablation of dental hard and soft tissues. It has been reported that this system is also useful for preparing tooth surfaces and etching, but no consensus exist in the literature regarding the advantage of lasers over conventional tooth preparation technique. MATERIALS AND METHODS: Labial surfaces of 25 extracted human maxillary central incisors were divided into two halves. Right half was prepared with diamond bur and left half with Er, Cr; YSGG laser and a reduction of 0.3-0.5 mm was carried out. Topography of prepared surfaces of five teeth were examined under scanning electron microscope (SEM). The remaining samples were divided into 4 groups of 10 specimens each based on the surface treatment received: One group was acid etched and other was nonetched. Composite resin cylinders were bonded on prepared surfaces and shear bond strength was assessed using a universal testing machine. RESULTS: The SEM observation revealed that the laser prepared surfaces were clean, highly irregular and devoid of a smear layer. Bur prepared surfaces were relatively smooth but covered with smear layer. Highest bond strength was shown by laser prepared acid etched group, followed by bur prepared the acid etched group. The bur prepared nonacid etched group showed least bond strength. CONCLUSIONS: Er, Cr: YSGG laser can be used for preparing tooth and bond strength value achieved by laser preparation alone without surface treatment procedure lies in the range of clinical acceptability.

Role of cytokines in development of pre-eclampsia associated with periodontal disease - Cohort Study.

AIM: The present study was designed to find any association of cytokines in women with periodontal disease and development of pre-eclampsia in North Indian population. MATERIALS AND METHODS: A total of 504 consecutively registered primigravida with a single live pregnancy were recruited at 14-18 weeks of gestation from antenatal clinic of Maulana Azad Medical College & associated Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences, New Delhi. One periodontist performed oral health examination of all patients at inclusion into study. Blood samples were collected to measure the level of cytokines IL-4, IL-10, TNF-α and IFN-γ. RESULTS: The profile of blood levels of cytokines from women with periodontal disease was observed. The log serum levels of TNF-α & IL-4 at 16-18 weeks of gestation were significantly higher in women with periodontal disease (4.13 ± 2.06; 0.47 ± 1.56 pg/ml respectively) than in women with healthy gums (2.16 ± 1.51; 0.02 ± 1.84 pg/ml respectively, p < 0.001). Periodontal disease is associated with log serum TNF-α levels at cut-off ≥14.43 pg/ml at sensitivity 71.2% and specificity 62% (OR = 4.04; 95%CI = 2.77-5.87). Woman with periodontal disease who later developed pre-eclampsia had lower levels of TNF-α (3.72 ± 1.33 pg/ml) than those with periodontal disease who did not develop pre-eclampsia (4.20 ± 2.15 pg/ml, p ≥ 0.05). CONCLUSION: Reduced TNF-α level secretion in the early second trimester in women with periodontal disease appears to be associated with the development of pre-eclampsia.

Type III talon cusp and Type III B dens invaginatus occurring simultaneously in a mandibular lateral incisor.

Talon cusp and dens invaginatus are developmental anomalies of the human dentition. They not only affect the esthetic appearance of teeth but also may create difficulties during dental treatment and lead to a number of dental problems. Both anomalies are observed most commonly in the lateral maxillary incisor and rarely in the mandibular dentition. The simultaneous occurrence of talon cusp and dens invaginatus in a single tooth is very rare in the mandibular dentition and, to the authors' knowledge, has not yet been reported in a mandibular lateral incisor. This article presents a rare case of dens invaginatus and talon cusp occurring concurrently in a mandibular lateral incisor. Three-dimensional imaging modality was used to describe the complex internal anatomy.

Patient satisfaction with complete dentures fabricated using two neutral zone techniques: a within-subject cross-over pilot study.

Several studies have compared complete dentures fabricated using conventional and neutral zone (NZ) techniques. However, studies comparing patient satisfaction with complete dentures fabricated using swallowing and phonetic NZ techniques are lacking in literature. To compare patient satisfaction with the complete dentures fabricated using the two NZ techniques. To compare the bucco-lingual dimensions of the NZ records obtained with these techniques. Ten completely edentulous subjects dissatisfied with their existing mandibular complete dentures participated in the study. Five subjects first received the swallowing neutral zone (SNZ) dentures and five the phonetic neutral zone (PNZ) dentures. Tissue conditioner was used as the recording material in both the techniques. After having worn the prosthesis for a minimum of 2 months, subjects responded to a questionnaire that measured their perceptions of various factors associated with the prosthesis. The prostheses were then changed and the procedures repeated. Student t test and non-parametric Mann-Whitney tests were used for statistical analysis. Level of statistical significance was set p < 0.05. There was no statistical significant difference in patient satisfaction with the SNZ and PNZ complete dentures for all the variables assessed. Statistical significant difference was observed for majority of the variables when the two NZ dentures were compared with patients' old dentures. The difference in the mean dimensions of the two NZ records was also found to be statistically insignificant except in the maxillary left premolar region. The study indicated that patient satisfaction with the complete dentures fabricated using SNZ technique did not significantly differ from that of the PNZ technique. Data gathered at the final appointment showed that SNZ dentures were preferred by the patients with regards to esthetics, stability, comfort and ability to chew. For ability to speak, mixed preferences were found.

Role of a dentist in comprehensive management of a comatose patient with post traumatic head injury and neuropathological chewing.

Injury of the head and neck region can result in substantial morbidity. Comprehensive management of such patients requires team work of several specialties, including dentists. A young female patient with extensive loss of cranium and associated pathological chewing was referred to the dental department. The lost cranium was replaced by a custom-made, hand-fabricated cranioplast. Trauma due to pathological mastication was reduced by usage of a custom-made mouthguard. Favorable results were seen in the appearance of the patient and after insertion of the mouthguard as evidenced in good healing response. The intricate role of a dental specialist in the team to manage a patient with post traumatic head injury has been highlighted. The take away message is to make the surgical fraternity aware of the scope of dentistry in the comprehensive management of patients requiring special care.