Study protocol for the management of impacted maxillary central incisors: a multicentre randomised clinical trial: the iMAC Trial

BACKGROUND Failure of eruption of the maxillary permanent incisor teeth usually presents in the mixed dentition between the ages of 7 and 9 years. Missing and unerupted maxillary incisors can be regarded as unattractive and have a potentially negative impact on facial and dental aesthetics. The presence of a supernumerary tooth (or odontoma) is commonly responsible for failed eruption or impaction of the permanent maxillary incisors. The primary objective of this trial is to investigate the success of eruption associated with maxillary incisor teeth that have failed to erupt because of a supernumerary tooth in the anterior maxilla. METHODS This protocol describes an interventional multicentre two-arm randomised clinical trial. Participants meeting the eligibility criteria will be randomised (unrestricted equal participant allocation [1:1]) to either space creation with an orthodontic appliance, removal of the supernumerary tooth and application of direct orthodontic traction or space creation with an orthodontic appliance, removal of the supernumerary tooth and monitoring. The primary outcome of this trial is to determine the prevalence of successfully erupted maxillary central permanent incisors at 6 months following removal of the supernumerary tooth. Secondary outcome measures include (1) the effect of initial tooth position (assessed radiographically) on time taken for the tooth to erupt, (2) time taken to align the unerupted tooth to the correct occlusal position, (3) gingival aesthetics and (4) changes in the self-reported Oral Health Related-Quality of Life (OHRQoL) (pre-and post-treatment). DISCUSSION There is a lack of high-quality robust prospective studies comparing the effectiveness of interventions to manage this condition. Furthermore, the UK national clinical guidelines have highlighted a lack of definitive treatment protocols for the management of children who present with an unerupted maxillary incisor due to the presence of a supernumerary tooth. The results of this trial will inform future treatment guidelines for the management of this condition in young children. TRIAL REGISTRATION ISRCTN Registry ISRCTN12709966 . Registered on 16 June 2022

Outcome measures in ULCP:the modified 5-Year-Olds'-Index-development and reliability

Objective: Can we reliably discriminate severity within the existing categories of the 5-Year-Olds’ Index? Design: Retrospective method comparison and development study. Setting: School of Oral and Dental Science, University of Bristol. Methods: Dental study models of 5-year-olds with unilateral cleft lip and palate (UCLP) were collected from the archives of 2 national cleft surveys (n = 351). One hundred randomly selected models were ranked to construct the modified 5-Year-Olds’ Index and also scored using a visual analogue scale (VAS). Reliability testing was performed on 51 study models. Visual analogue scale scores were used to aid statistical analysis and investigate the reliability of a VAS for outcome measurement. The modified 5-Year-Olds’ Index was then applied to 198 study models of 5-year-olds with UCLP. Results: The modified 5-Year-Olds’ Index showed excellent intra and interexaminer agreement (intraclass correlation &gt; 0.94) and good discrimination of severity. When applied to the Cleft Care UK participants (n = 198), the modified 5-Year-Olds’ Index showed good discrimination of severity within the better categories (groups 1-3) of the 5-Year-Olds’ Index. Visual analogue Scale scores resulted in unacceptable variation between measurements. Conclusions: The new modified 5-Year-Olds’ Index is a reliable method of assessing outcomes at 5 years of age and showed improved discriminatory power between the “better” outcome categories than the original 5-Year-Olds’ Index. A VAS was found to be unsuitable for assessing outcome at 5 years of age for children with UCLP. </jats:sec

Supplemental Material, Reference_Models - Outcome Measures in ULCP: The Modified 5-Year-Olds’-Index—Development and Reliability

<p>Supplemental Material, Reference_Models for Outcome Measures in ULCP: The Modified 5-Year-Olds’-Index—Development and Reliability by Tarun K. Mittal, Anthony J. Ireland, Nikki E. Atack, Sam D. Leary, Joyce I. Russell, Scott A. Deacon, Andy R. Ness, and Jonathan R. Sandy in The Cleft Palate-Craniofacial Journal</p