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

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Jadbinder Seehra, Andrew T. DiBiase, Shruti Patel, Rachel Stephens, Simon J. Littlewood, Richard J. Spencer, Tom Frawley, Philip E. Benson, Anthony J. Ireland, Farnaz Parvizi, Nikki Atack, Giles Kidner, Gabriella Wojewodka, Christopher Ward, Spyridon N. Papageorgiou, Jonathon T. Newton, Martyn T. Cobourne

Original languageEnglish
Article number787
JournalTrials
Volume23
Issue number1
Early online date16 Sep 2022
DOIs
Accepted/In press3 Sep 2022
E-pub ahead of print16 Sep 2022
PublishedDec 2022

Bibliographical note

Funding Information: The authors wish to thank the British Orthodontic Society Foundation for providing funding for this trial. Publisher Copyright: © 2022, The Author(s).

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Abstract

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.

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