The iMAC Trial (Management of impacted MAxillary Central incisors)
Research type
Research Study
Full title
Management of impacted maxillary central incisors: a multicentre randomised clinical trial
IRAS ID
280185
Contact name
Martyn Cobourne
Contact email
Sponsor organisation
King's College London
ISRCTN Number
ISRCTN12709966
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Failure of a front tooth in the top jaw to erupt is a common problem in young children aged between 8-10.5 years affecting approx. 3% of the population resulting in a disturbance in dental development, spacing between the teeth, an unattractive smile and a compromise in aesthetics. The impact of not having a front tooth in the top jaw present can cause a negative impact on a child’s self-esteem, social interaction and potentially predispose a child to bullying episodes. In the United Kingdom, in about 50% of cases the cause for the failure of the front tooth to erupt into its normal position is the presence of an extra tooth. In this situation, it is unlikely that the top front tooth will erupt spontaneously hence increasing the need for complex and costly multidisciplinary treatment.
Treatment considered in this clinical situation are: 1) to remove the extra tooth and allow the front tooth to spontaneously erupt or 2) removing the extra tooth, surgical uncovering and bonding a gold chain to the front tooth and using an orthodontic brace to align the tooth.
The disadvantages of the first approach are that the time taken for the tooth to erupt is very variable and it may erupt into a malaligned position, hence requiring further treatment. The second approach is associated with more predictability in terms of the time taken to align the tooth but may result in possible unesthetic alteration of the natural gumline. The current evidence base for best practice is poor. The measurement of outcomes important to patients affected by this condition are also lacking. This study which will be carried out at NHS sites aims to investigate the success of top front tooth eruption following removal of the extra tooth with and without immediate application of orthodontic brace forces.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
22/NW/0062
Date of REC Opinion
22 Mar 2022
REC opinion
Further Information Favourable Opinion