A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan

Background Cleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, hearing, dental development, and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. The Timing Of Primary Surgery for cleft palate (TOPS) trial aims to determine whether, in infants with cleft palate, it is better to perform primary surgery at age 6 or 12 months (corrected for gestational age). Methods/design The TOPS trial is an international, two-arm, parallel group, randomised controlled trial. The primary outcome is insufficient velopharyngeal function at 5 years of age. Secondary outcomes, measured at 12 months, 3 years, and 5 years of age, include measures of speech development, safety of the procedure, hearing level, middle ear function, dentofacial development, and growth. The analysis approaches for primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The TOPS protocol has been published previously. Discussion This paper provides details of the planned statistical analyses for the TOPS trial and will reduce the risk of outcome reporting bias and data-driven results. Trial registration ClinicalTrials.gov NCT00993551. Registered on 9 October 2009.

OPTICAL DENSITY OF DIFFERENT PARTS OF JAWS IN ORTHODONTIC PATIENTS DURING DENTOFACIAL DEVELOPMENT

The growth and development of the facial skeleton is closely related to the growth of the cervical division of the spinal column. With a total increase in rate of osteopenic diseases and diseases of periodontal tissues, computed tomography becomes a particular relevant diagnostic technique for assessing bone density. The aim of this study was to carry out a comparative analysis of the mineral density values of the jaw bone tissue and the mineral density values of the second cervical vertebra in patients with malocclusions. Materials and methods. We analyzed 22 computer tomograms of orthodontic patients and divided all cases into two age groups according to the periods of dentofacial development. The bone density of the second cervical vertebra and jaw bones was measured in various sections. Results. The optical bone density in the second cervical vertebra increases with age from 501±61.06 to 550.6±45.32. The densest area in both jaws is the alveolar ridge between the central incisors. The lowest values of optical density were found in the area of the upper jaw tuberosity in both groups. In the lower jaw, similar results of bone density were found out in the second cervical vertebra and the articular head, 436 HU and 557 HU in the groups I and II, respectively. In both jaws, the most similar densitometric indicators of bone density were found in the second cervical vertebra and the bifurcation site of the first molars. Only in the group II, this figure was 724.77±41.64 HU at p2<0,01 in the lower jaw. Conclusions. Bone tissue densitometry by computed tomography is a highly informative diagnostic technique and can be used to diagnose the condition of the jaw bone tissue and to assess the quality of orthodontic treatment. The value of the second cervical vertebra is a stable indicator of mineral density in all age groups. The results obtained allow us to recommend applying these indicators for the comparative characteristic of change in mineral density in the alveolar processes of jaw bones to check the progress of orthodontic treatment.

Timing Of Primary Surgery for cleft palate (TOPS): protocol for a randomised trial of palate surgery at 6 months versus 12 months of age

IntroductionCleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, speech, hearing, dental development and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. This has led to palatal closure in one-stage procedures being carried out around the age of 12 months, but in some cases as early as 6 months. The primary objective of the Timing Of Primary Surgery for Cleft Palate (TOPS)trial is to determine whether surgery for cleft palate performed at 6 or 12 months of age is most beneficial for speech outcomes.Methods and analysisInfants with a diagnosis of non-syndromic isolated cleft palate will be randomised to receive standardised primary surgery (Sommerlad technique) for closure of the cleft at either 6 months or 12 months, corrected for gestational age. The primary outcome will be perceived insufficient velopharyngeal function at 5 years of age. Secondary outcomes measured across 12 months, 3 years and 5 years will include growth, safety of the procedure, dentofacial development, speech, hearing level and middle ear function. Video and audio recordings of speech will be collected in a standardised age-appropriate manner and analysed independently by multiple speech and language therapists. The trial aims to recruit and follow-up 300 participants per arm. Data will be analysed according to the intention-to-treat principle using a 5% significance level. All analyses will be prespecified within a full and detailed statistical analysis plan.Ethics and disseminationEthical approval has been sought in each participating country according to country-specific procedures. Trial results will be presented at conferences, published in peer-reviewed journals and disseminated through relevant patient support groups.Trial registration numberNCT00993551; Pre-results.

Effect of Naso-respiratory Obstruction with Mouth Breathing on Dentofacial and Craniofacial Development

Objective: To evaluate the effects of mouth breathing on craniofacial and dentofacial development during childhood in comparison to nasal breathing in malocclusion patients.Materials & Method: A retrospective study done at SOA University. Cephalometric parameters and clinical variables of 90 pediatric patients who had undergone orthodontic treatment were reviewed. Study group included 40 pediatric patients who suffered from signs and symptoms of nasal obstruction, and control group included 50 patients who were normal nasal breathers. Dental and craniofacial parameters were compared between nasal breathers and mouth breathers using clinical and cephalometric records.Result: The mouth breathers had backward and downward rotation of mandible with increased overjet, increased mandibular plane angle, higher palatal plane, and constriction of upper and lower arches at the level of cuspids and first molars when compared with nasal breathers group. The prevalence of posterior cross bite was observed greater in mouth breathers group (40%) than the nose breathers (20%) (p =0.006). Abnormal lip-to-tongue anterior oral seal was seen more in the mouth breathers group (55%) than in nose breathers group (25%) (p = 0.05).Conclusion: Naso-respiratory obstruction with mouth breathing during growth periods in children has a greater tendency for clockwise rotation of growing mandible, with an irregular increase in anterior lower vertical face height and decreased posterior facial height.

Novel 3-D Analysis for the Assessment of Cleft Dimensions on Digital Models of Infants With Unilateral Cleft Lip and Palate

Objective: To present a 3-D standardized analysis of cleft dimensions. Materials: Thirty-one plaster casts of unilateral cleft lip and palate (UCLP) infants were laser scanned. Landmarks and coordinate system were defined. Linear distances and surfaces were measured, and the ratio between cleft and palatal area was calculated (3-D infant cleft severity ratio [3D ICSR]). The digitally measured areas were compared with silicone membranes, adapted to the plaster casts, and analyzed by optic microscopy. Main Outcome Measures: Repeatability, reproducibility, and validity. Results: Bland-Altman plots showed minor bias for anterior cleft width (0.16 mm), arch length (0.23 mm), and palatal surface (−9.18 mm2). The random error was maximum 0.78 mm for linear measurements and 12.1 mm2 for area measurements, reliability of 3D ICSR was 0.99 (intraclass correlation coefficient), differences between measurements on digital and plaster models were less than 2%. Conclusions: The method offers valid and reproducible 3-D assessment of cleft size and morphology. 3-D infant cleft severity ratio can be used as baseline value for surgical planning and may have a role in predicting dentofacial development.

14th International Symposium on Dentofacial Development and Function & 11th National Congress on Orthodontics Beijing, China, Sept. 19-23, 2012

not availableBan J Orthod & Dentofac Orthop, April 2014; Vol-4 (1-2), P.35