A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial.

BACKGROUND: Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment. METHOD: The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site. DISCUSSION: We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe. TRIAL REGISTRATION: ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up. How to search: ( https://ctri.nic.in/Clinicaltrials/advsearch.php -use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC).

Isolated Paramedian cleft of Lower LIP: A Rare Entity.

Objective: To present a rare case of an isolated paramedian cleft of the lower lip. We describe the second case of isolated paramedian cleft of the lower lip. The pregnancy was realized in the fifth month prior to which the mother gives history of consumption of non-steroidal anti-inflammatory drugs (N.S.A.I.D.s) and a computed tomography (C.T.) scan. The cleft was repaired with a z-plasty for the mucosa and a z-plasty for the skin. We achieved good vermilion bulk, white roll continuity and functionality. We attributed this cleft to maternal exposure to NSAIDs and radiation during early pregnancy.

Furlow Palatoplasty for Velopharyngeal Dysfunction Management: Auditing and Predicting Outcomes.

OBJECTIVE: The Furlow palatoplasty is a proven procedure in the management of secondary velopharyngeal dysfunction in patients with cleft palate. But the selection of cases, the degree of clinical success, and the preoperative predictors of the same are less established. This study is an effort to retrospectively look at outcomes, in a large series of velopharyngeal dysfunction cases treated with the Furlow palatoplasty alone. DESIGN: Retrospective analysis of preoperative and postoperative speech and videofluoroscopic data. SETTING: Tertiary care center. PATIENTS/PARTICIPANTS: Ninety-two patients who were diagnosed with velopharyngeal dysfunction post primary cleft palate repair. INTERVENTIONS: Furlow palatoplasty for velopharyngeal dysfunction post primary cleft palate repair. MAIN OUTCOME MEASURES: Variables analyzed were perceptual speech parameters and, closure ratios obtained from lateral video-fluoroscopic images. RESULTS: Overall, 81.5% had postoperative improvements in their lateral video-fluoroscopic parameters, 63% improved their nasality scores, and 65.2% had improved speech intelligibility. A simple linear regression was done to predict the postoperative closure ratio. Preoperative closure ratio, hypernasality (moderate and severe), and audible nasal air emission are predictors for postoperative closure ratio. CONCLUSIONS: The Furlow palatoplasty alone led to complete resolution, or significant improvement of velopharyngeal dysfunction in a majority of patients, despite the cohort having a wide range of severity in terms of degree of dysfunction. The predictive formula will be validated in a further study.

Long-Term Comparison of the Aesthetic Outcomes between Nasoalveolar Molding- and Non-Nasoalveolar Molding-Treated Patients with Unilateral Cleft Lip and Palate.

BACKGROUND: The cleft lip-nose deformity in unilateral cleft lip and palate is one of the most challenging problem for surgeons to correct. Although nasoalveolar molding has been shown to be effective in improving presurgical symmetry in patients with complete unilateral cleft lip and palate, there is need for better evidence regarding the long-term nasolabial aesthetics of patients who have received this therapy. METHODS: Thirty-eight patients treated with nasoalveolar molding and 48 patients not treated with nasoalveolar molding (but otherwise treated similarly) with unilateral cleft lip and palate were studied to assess and compare the nasolabial aesthetics. The objective evaluation of the nasal symmetry was performed on the basal view of two-dimensional photographs and the subjective nasolabial aesthetic evaluation was performed using the Asher-McDade scale. RESULTS: At 5-year postoperative follow-up, nasoalveolar molding group patients had better mean values on the objective scores; however, these were not statically significant. The nasoalveolar molding group of patients had a statistically significant improvement in the subjective evaluation in comparison to the non-nasoalveolar molding-treated patients. The number of lip revisions was also statistically higher in the non-nasoalveolar molding-treated group of patients. CONCLUSIONS: In this retrospective, single-center study, the authors found that at 5-year postoperative follow-up, nasoalveolar molding-treated patients had improved nasolabial aesthetics and fewer revision operations. These are, however, preliminary results and the patients will be followed up until the end of growth to assess the longer term effects of nasoalveolar molding on the nasolabial aesthetics in unilateral cleft lip and palate. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Alveolar bone grafting and gingivoperiosteoplasty in bilateral cleft lip and palate.

PURPOSE OF REVIEW: Gingivoperiosteoplasty (GPP) and alveolar bone grafting (ABG) procedures have a vast history. There have been many publications regarding ABG and secondary ABG, with and without presurgical infant orthopedics (PSIO), in bilateral cleft lip and palate patients. There is little long-term data available describing results of both techniques. RECENT FINDINGS: The interdisciplinary approach to primary and secondary surgical procedures has proven to be beneficial for patients with bilateral cleft lip and palate. In the neonates, naso-alveolar molding (NAM) has been found to optimize the aesthetic outcome as well as re-approximating the arches to facilitate GPP. During the mixed dentition stage, arch preparation/expansion before the secondary ABG procedure improves arch morphology, restores the functional interarch relationship, and facilitates surgery. SUMMARY: This review aims to highlight the key points of both the procedures and why combining both procedures along with PSIO procedures such as NAM might be helpful for the patients in the long term.

SARS-CoV-2, Uncontrolled Diabetes and Corticosteroids-An Unholy Trinity in Invasive Fungal Infections of the Maxillofacial Region? A Retrospective, Multi-centric Analysis.

OBJECTIVES: Collate and analyse data of maxillofacial/rhino-cerebro-orbital fungal infections reported during the era of the Covid-19 pandemic, with the aim of investigating the common contributing factors leading to such infections and of highlighting the significance of this surge seen in patients infected with SARS-CoV-2. METHOD: This retrospective observational multi-centric study analysed patient data collected from clinicians belonging to different specialties in Bangalore, India. The data included the presentation and management of patients presenting with aggressive maxillofacial and rhino-cerebro-orbital fungal infections and explored the relationship between SARS-CoV-2, corticosteroid administration and uncontrolled diabetes mellitus. RESULTS: All 18 patients were Covid positive. Sixteen of the 18 patients received steroids for Covid treatment and 16 patients were diabetic (of whom 15 patients who were diabetics received steroids for Covid-19 treatment). Loss of vision was noted in 12 of the 18 patients and 7 of them underwent orbital exenteration. The fungi noted was mucormycosis in 16 patients, aspergillosis in 1 patient and a mixed fungal infection in 1 patient. Eleven of the patients survived, 6 died and 1 was lost to follow-up. There was a significantly higher incidence of diabetes (p = 0.03) amongst these cohort of patients who were Covid-19 positive with mucormycosis. A significantly higher number (p = 0.0013) of patients were administered steroids at some point during the treatment. CONCLUSION: Despite the limited sample size, it is evident that there is a significant increase in the incidence of angioinvasive maxillofacial fungal infections in diabetic patients treated for SARS-CoV-2 with a strong association with corticosteroid administration.

Management of the Nasal Deformity in the Unilateral Cleft of the Lip and Nose.

Cleft rhinoplasty is a demanding, technique-sensitive procedure. Part art, part science; it poses several probing questions to the surgeon. The unilateral cleft nasal deformity is a distinct entity because the pursuit of symmetry in the unilateral cleft nose makes the repair much more challenging. The advent of nasoalveolar moulding, the gaining popularity of primary (early) nasal repair and greater refinements in secondary (definitive) rhinoplasty techniques have contributed to better nasal results in unilateral cleft repair. Yet, some obstacles remain. This paper aims to discuss the anatomy of the unilateral cleft nose, enumerate aims and objectives of repair at every stage, and to demonstrate the evolution and varied rationale of management of nasal deformities in the unilateral cleft lip and nose.

A Longitudinal Study of The Nasal Symmetry in Unilateral Cleft Lip And Palate Patients Treated With Nasoalveolar Molding.

Background Nasoalveolar molding (NAM) has been extensively used as a presurgical technique in the treatment of unilateral cleft lip and palate (UCLP) over the last two decades. It has proven to be a useful tool to reduce the cleft size, improve nasal symmetry, and increase the columellar length. The long-term stability of these findings has not been conclusively proven. Methods In this longitudinal study, the nasal symmetry of 24 NAM treated UCLP patients was evaluated to assess the 5-year stability of NAM. The basal photographs were shot postcheiloplasty (T1), at 1-year follow-up (T2), at 3-year follow-up (T3), and 5-year follow-up (T4) appointments. Results In this study, we found that NAM was a useful adjuvant in achieving nasal symmetry in patients with UCLP in the immediate postoperative period. However, as the patients aged, there was a gradual loss of mean nasal height (by 22.83%) and columella length (by 24.89%), a mean gain in nasal width (by 40.25%) and alar base width (by 40.69%), and an increase in the columella deviation (by 3.46%) from the T1 to the T4 follow-up. Conclusion Although there is no conclusive evidence, the loss of symmetry may be due to the unequal growth on the cleft and noncleft sides. These patients will be followed-up till end of growth for a definite conclusion on the long-term effect of NAM.

A Comparative Cephalometric Study of Nasoalveolar Molding- and Non-Nasoalveolar Molding-Treated Bilateral Cleft Patients at Early Mixed Dentition Period.

OBJECTIVE: To evaluate and compare early maxillary growth in 2 groups of patients with repaired bilateral cleft lip and palate (BCLP) who had and had not received nasoalveolar molding (NAM) therapy in infancy. HYPOTHESIS: Nasoalveolar molding does not have any effect on maxillomandibular growth at the early mixed dentition period. DESIGN: Retrospective study. PATIENTS: The study group consisted of forty-two 7-year-old patients with BCLP-20 in the NAM group and 22 in the no-NAM group. The control group consisted of nineteen 7-year-old noncleft, normal patients. INTERVENTIONS: Nasoalveolar molding was carried out prior to surgeries in those children who were brought in within 8 weeks of birth. Children brought in later were treated without a presurgical intervention. All patients were treated with a single-stage modified Millard cheiloplasty without gingivoperiosteoplasty. Palatoplasty was done by single-stage Bardach palatoplasty with muscle repositioning. MEAN OUTCOME MEASURES: Hard tissue and dental cephalometric values measured on lateral cephalograms, recorded at 7 years of age. RESULTS: A comparison of the mean sagittal values showed a statistically significant maxillomandibular retrusion and incisor retroclination of both BCLP groups in comparison to the control group. None of the cephalometric parameters varied statistically between NAM and no-NAM groups. The maxillomandibular relation, lower face height ratio, mandibular plane, and mandibular axis angles did not show statistically significant difference between all 3 groups. CONCLUSIONS: On the basis of this study, NAM does not have any effect on maxillomandibular growth at the early mixed dentition period.

Triclosan: Hazards of Overuse are not limited to Antibiotics.

Antibiotic abuse by patients and overprescription by some dentists are problems in modern healthcare practice. Less understood are the deleterious effects of antiseptics in oral care products marketed for routine home use. Ample literature exists to condemn the routine use of mouthrinses, but criticism focuses on alcohol content and its effects on oral mucosa.1 We highlight the more insidious problem of triclosan, which is added as an antiseptic to toothpastes and mouthrinses.

Risk factors for orofacial clefts in India: A case-control study.

BACKGROUND: Orofacial clefts (OFC) are linked with several genetic and environmental factors. The aim of this study was to explore the association of potential risk factors with OFCs in India. METHODS: This was a hospital-based, matched case-control (1:4 ratio; matching done for parity) study conducted in Hyderabad, Bengaluru, and Delhi-National Capital Region. Cases (nonsyndromic clefts) were recruited from treatment centers, while controls (live births) were recruited from maternity centers. Information on exposures was collected during personal interviews. Exposures of interest included folic acid supplementation during the peri-conceptional period, consanguineous marriage, exposure to drugs, infections during pregnancy, family history of OFC, and dietary factors. RESULTS: A total of 785 participants were included in the study: 157 cases and 628 controls. A family history of cleft lip/palate (adjusted odds ratio [AOR], 15.48; 95% confidence interval [CI], 4.36-54.96; p value = 0.001), exclusive vegetarianism (AOR, 4.47; 95% CI, 1.83-10.98; p value = 0.001), and delayed first conception (AOR, 2.55, 95% CI, 1.25-5.21, p = 0.01) were found to be strongly associated with higher risk of OFCs. Supplementation with folic acid during first 3 months of pregnancy was not found to be protective against OFCs (AOR, 1.24; 95% CI, 0.59-2.58; p value = 0.56). CONCLUSION: Our study confirmed the importance of family history as a risk factor for OFC. Our study did not show an association with folic acid supplementation but was underpowered to detect small effects. Our finding of higher risk among vegetarians requires replication. Birth Defects Research 109:1284-1291, 2017. © 2017 The Authors. Birth Defects Research Published by Wiley Periodicals, Inc.

A Standard Set of Outcome Measures for the Comprehensive Appraisal of Cleft Care.

Care of the patient with cleft lip and/or palate remains complex. Prior attempts at aggregating data to study the effectiveness of specific interventions or overall treatment protocols have been hindered by a lack of data standards. There exists a critical need to better define the outcomes-particularly those that matter most to patients and their families-and to standardize the methods by which these outcomes will be measured. This report summarizes the recommendations of an international, multidisciplinary working group with regard to which outcomes a typical cleft team could track, how those outcomes could be measured and recorded, and what strategies may be employed to sustainably implement a system for prospective data collection. It is only by agreeing on a common, standard set of outcome measures for the comprehensive appraisal of cleft care that intercenter comparisons can become possible. This is important for quality-improvement endeavors, comparative effectiveness research, and value-based health-care reform.

Presurgical nasoalveolar moulding in unilateral cleft lip and palate.

CONTEXT: Presurgical nasoalveolar moulding (PNAM) is a non-surgical method of reshaping the cleft lip, alveolus, palate and the nose to minimize the severity of the cleft deformity, before primary cheiloplastyand palatoplasty. In this context, PNAM proves to be an invaluable asset in the management of unilateral cleft lip and palate. AIMS: The study was conducted to evaluate the efficacy of PNAM in the management of unilateral cleft lip and palate with the following objectives: (1) To assess and compare the degree of reduction in the size of cleft palate and alveolus (pre-PNAM and post-PNAM). (2) To evaluate and compare the improvement in columellar length and correction of columellar deviation (pre-PNAM and post-PNAM). (3) To assess the changes in the position of the alar base and the alar cartilages. SETTINGS AND DESIGN: Prospective study. SUBJECTS AND METHODS: A prospective study consisting of, which included 20 patients with complete unilateral cleft lip and palate was conducted. The age at the start of PNAM treatment of the infants ranged from 2 to 44 days of age reporting to our institute between December 2011 and August 2013. All the patients underwent PNAM therapy before primary cheiloplasty at 6 months of age; clinical parameters were assessed pre- and post-therapy using photographs and dental study models of the maxilla. STATISTICAL ANALYSIS USED: Student's t-test for paired comparisons. RESULTS: Results of the study showed a promising reduction in the cleft size before the surgery, significant improvement in nasal symmetry, including the columellar length on the cleft side. CONCLUSIONS: PNAM is a valuable adjunct to our surgical armamentarium in dealing with the challenges of primary closure of unilateral cleft lip and palate thereby enhancing the overall surgical outcome. The advantages of this method include the simplicity of the procedure and improving the quality of surgical repair, particularly in obtaining tension free muscle closure in unilateral clefts.

Treatment modalities for surgical management of anterior palatal fistula: Comparison of various techniques, their outcomes, and the factors governing treatment plan: A retrospective study.

AIM: Aim of this retrospective study was to access the various surgical treatment options available for repair of Anterior palatal fistula depending upon their size and presenting age, and also to anticipate the treatment outcome. MATERIALS AND METHODS: The series include study report of forty patients with secondary anterior palatal fistula post cleft palate repair, reported in a single unit during a duration of 3 years. All the cases were managed surgically under general anesthesia. The patients were classified depending upon the location of anterior palatal fistula (APF), the quality of tissue and age of patients to chalk out a justified treatment option outlay. RESULTS: Forty cases were split for surgical correction into various options depending on their size, site, and quality of the tissue. Most of the cases were operated with a Bardach's Redo for fistula closure (n = 16) (40%) and crevicular flap technique (n = 13) (32.5%). Our overall success (satisfactory results) was 77.5% as observed in 31 out of 40 cases with individual success rates for Bardach's and crevicular being 75% and 77%, respectively. There was reduction in size of fistula in three cases (7.5%) and a remnant pinpoint hole in four cases (10%) among all the operated cases. CONCLUSION: Management of post palatoplasty fistulas of the hard palate presents a challenging situation for a clinician following the surgical correction of cleft palate. Current paper describes the diagnosis and clinical management of forty cases reporting with unilateral APF following cleft palate surgery, over 3 years. Authors have attempted to propose different treatment modalities for surgical management of unilateral APF. It was concluded in the primary review that the size of fistula was irrelevant in determining the clinical outcome. Instead, the quality and condition of the adjacent tissue appear to be the major governing factors for selecting treatment modality as well as the surgical consequences.

Open versus closed rhinoplasty with primary cheiloplasty: a comparative study.

The repair of unilateral cleft lip nose deformity remains a challenging endeavor for reconstructive surgeons for many reasons, one of which is the timing of rhinoplasty, whether to be synchronous or staged with cleft lip repair and the technique for rhinoplasty. Many authors now favor primary rhinoplasty with the cleft lip repair. Various surgical techniques have been used, most commonly the closed and open rhinoplasty techniques. In this randomized controlled prospective study, we compare the closed rhinoplasty technique with open rhinoplasty during primary unilateral cleft lip repair. Thirty-six patients with unilateral complete cleft lip and nose deformity were selected. Out of this 19 patients were assigned randomly and operated with open rhinoplasty and 17 patients with closed rhinoplasty. The cleft lip repair was done using modified, Millard's rotation-advancement technique in both the groups. Follow-up assessment was done after 6 months. Quantitative and qualitative analysis were done. Statistical analysis of the data was done using SPSS 11.0. Post-operatively, the alar base width difference between the open and closed rhinoplasty techniques was statistically significant. There was no statistically significant difference in other parameters compared.

Unfavourable outcomes in orthognathic surgery.

Unfavourable outcomes are part and parcel of performing surgeries of any kind. Unfavourable outcomes are results of such work, which the patient and or the clinician does not like. This is an attempt to review various causes for unfavorable outcomes in orthognathic surgery and discuss them in detail. All causes for unfavorable outcomes may be classified as belonging to one of the following periods A) Pre- Treatment B) During treatment Pre-Treatment: In orthognathic surgery- as in any other discipline of surgery- which involves changes in both aesthetics and function, the patient motivation for seeking treatment is a very important input which may decide, whether the outcome is going to be favorable or not. Also, inputs in diagnosis and plan for treatment and its sequencing, involving the team of the surgeon and the orthodontist, will play a very important role in determining whether the outcome will be favorable. In other words, an unfavorable outcome may be predetermined even before the actual treatment process starts. During Treatment: Good treatment planning itself does not guarantee favorable results. The execution of the correct plan could go wrong at various stages which include, Pre-Surgical orthodontics, Intra and Post-Operative periods. A large number of these unfavorable outcomes are preventable, if attention is paid to detail while carrying out the treatment plan itself. Unfavorable outcomes in orthognathic surgery may be minimized If pitfalls are avoided both, at the time of treatment planning and execution.

Ophthalmic considerations in cleft lip and palate patients.

Cleft lip and palate (CL and P) represents the second most frequently occurring congenital deformity after clubfoot deformity. CL and P could be associated with many other structural abnormalities of the adjacent vital structures of the face. In this study, an attempt was made to identify the abnormalities of the ocular structures seen in patients with isolated CL and P as well as in those with syndromic CL and P. Of the 322 patients with cleft lip and palate screened, 27 (8.3%) had ocular abnormalities. Totally 47 ocular defects were identified in 27 patients. Abnormalities of the eyelid were the commonest accounting for 22% of the total defects (11/47), which includes symblepharon, ectropion, lid colobomas, euryblepharon and ptosis. Second commonest abnormality was squint 8/47 (17%) followed by orbital defects 8/47 (17%) (Telecanthus and Hypertelorism). Abnormalities of the nasolacrimal apparatus 3/47 (6%), refractive errors 7/47 (15%), dermoids 4/47 (6%), cataract 2/47 (4%) and retinal colobomas 2/47 (4%) constituted the rest. Thus, children with cleft lip and palate should be assessed as soon as possible after birth by a multidisciplinary team involving the Pediatrician, Ophthalmologist and specialists from Maxillofacial, ENT and Plastic surgery. The medical problems in this group of children are global and therefore, should not be looked at in isolation.

Keloidoscope: in search for the ideal treatment of keloids.

Although keloids were recognised in the Smith Papyrus of ancient times, the precise definition, cause and management have remained elusive. Several forms of treatment have been used with varying success.Objectives This study assesses and compares the value of intralesional steroid (Triamcinolone acetonide 40mg/ml), cryotherapy and cryotherapy with intralesional steroid in the treatment of keloids.Methodology 33 patients were studied, 11 each in the three arms and the volume of the keloids was recorded using wax patterns of alginate impressions of the keloids to note the change in size postoperatively.Results The best average percentage response was observed is patients who received both Cryotherapy (CRY) and Intralesional Steroid (ILS) (69.02%) followed by patients who received only intralesional steroid (43.98%). Among the patients who received only cryotherapy, the average percentage response was only 39.24%. 72.73% patients who received intralesional steroid with cryotherapy showed more than 50% improvement (good response) while only 9.09% patients who received intralesional steroid alone and cryotherapy alone showed similar improvement.Conclusion In patients with keloids good response can be obtained with CRY with ILS as compared to ILS alone and CRY alone.