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 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)

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 effi cacy 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, signifi cant 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

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

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