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Open Access 01-12-2022 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2022

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.

Available only for authorised users

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Title: Study protocol for the management of impacted maxillary central incisors: a multicentre randomised clinical trial: the iMAC Trial
Authors: 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
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06711-0

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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