The iMAC Trial (Management of impacted MAxillary Central incisors)

Not Applicable

• Conditions: nerupted (impacted) maxillary incisor teeth with associated supernumerary tooth; Oral Health

• Registration Number: ISRCTN12709966
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-16
• Last Update Posted: 5 August 2022
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. Aged between 8-10.5 (6 months to the day after their 10th birthday) years
2. Fit and well
3. Good oral hygiene
4. Present with the Unilateral impaction of an upper maxillary central incisor due to the presence of a (supernumerary) tooth
5. In the mixed dentition with eruption of upper 6’s, single maxillary central incisor and lateral incisors
6. Parents able to give informed consent

Exclusion Criteria

1. History of previous orthodontic treatment
2. Presence of an impacted maxillary incisor due to root dilaceration/unfavourable morphology
3. Participants participating in other trials or studies
4. Participants with a history of nickel allergy
5. Participants who decline to take part in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of successfully erupted permanent maxillary incisors (top front tooth) following removal of the supernumerary tooth (obstruction) measured using clinical assessment of intra-oral photographs at baseline and 6 months. The successful eruption will be defined as the eruption (successful outcome) of the unerupted maxillary central through the gingival mucosa during the 6-month observation period. Clinically, the amount of clinical crown visible should allow the placement of an orthodontic attachment or removal of the bonded gold chain attachment and placement of an orthodontic attachment/bracket.