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).

Anterior Segmental Distraction Osteogenesis in the Hypoplastic Cleft Maxilla: Report of five cases.

Orthognathic surgery and distraction osteogenesis play a prime role in the correction of maxillary hypoplasia in patients with cleft lip and palate (CLP). Advancement of the anterior maxilla alone without interfering with the velopharyngeal sphincter may be advantageous in cleft patients, who more commonly have speech deficits and dental crowding. We present a case series of anterior maxillary segmental distraction for maxillary hypoplasia in 5 CLP patients with a one-year follow-up. A custom-made tooth-borne distraction device with a hyrax screw positioned anteroposteriorly was used. The evaluation comprised of hard and soft tissue analysis and speech assessment. A stable occlusion with positive overjet and correction of dental-crowding without extraction was achieved at one year post-distraction. Facial profile and lip support improved. There was no deterioration in speech.

Evaluation of demineralization adjacent to orthodontic bracket and bond strength using fluoride-releasing and conventional bonding agents.

BACKGROUND AND OBJECTIVES: One of the most difficult problems encountered in orthodontic treatment with fixed appliance is the control of enamel demineralization around the brackets. Fluoride-releasing bonding adhesives were introduced to aid in the prevention of demineralization adjacent to orthodontic brackets. Hence, an in vitro study was conducted to evaluate and compare demineralization adjacent to the orthodontic bracket and the bond strength using fluoride-releasing adhesive and conventional adhesive. MATERIALS AND METHODS: One hundred and twenty healthy extracted premolars were selected for the study and were divided into two groups, each group consisting of 60 teeth. Both groups were further divided into three subgroups consisting of 20 samples each. Samples of subgroups A and B were bonded with two prototypes of fluoride-releasing adhesives (i.e. Rely-a-bond and Tru-bond). Samples of subgroup C (ortho-one) were bonded with conventional non-fluoride-releasing adhesive. Group I samples were subjected to demineralization in an acidic medium (methyl cellulose buffered with acetic acid at a pH of 4.5) for 4 weeks, which were later observed under a stereomicroscope. Group II samples were tested for shear bond strength using the Instron Universal testing machine. RESULTS: Both fluoride-releasing adhesives showed statistically significant lower enamel demineralization around the bracket when compared with the conventional adhesive. There was no statistically significant difference on comparing the demineralization between the two prototypes of fluoride-releasing adhesive. Evaluation of shear bond strength revealed that there was no significant difference between the subgroups. CONCLUSION: Fluoride-releasing adhesives might aid in the prevention of demineralization adjacent to the orthodontic bracket with acceptable bond strength.

Crystal growth vs. conventional acid etching: a comparative evaluation of etch patterns, penetration depths, and bond strengths.

The present study was undertaken to investigate the effect on enamel surface, penetration depth, and bond strength produced by 37% phosphoric acid and 20% sulfated polyacrylic acid as etching agents for direct bonding. Eighty teeth were used to study the efficacy of the etching agents on the enamel surface, penetration depth, and tensile bond strength. It was determined from the present study that a 30 sec application of 20% sulfated polyacrylic acid produced comparable etching topography with that of 37% phosphoric acid applied for 30 sec. The 37% phosphoric acid dissolves enamel to a greater extent than does the 20% sulfated polyacrylic acid. Instron Universal testing machine was used to evaluate the bond strengths of the two etching agents. Twenty percent sulfated polyacrylic acid provided adequate tensile bond strength. It was ascertained that crystal growth can be an alternative to conventional phosphoric acid etching as it dissolves lesser enamel and provides adequate tensile bond strength.

Molar bands for 'precision' bonding of lingual retainers.

Bonded retainers have been used principally for long-term retention of treated cases. Various methods of bonding lingual retainers have been described in the literature over the past two decades. However, accurate and passive placement of retainers has always been a matter of concern. This report presents a simple and economical method for accurate and passive placement of bonded lingual retainers that enables the operator to save considerable chair time.