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

被引：5

作者：

Seehra, Jadbinder ^{[1
]}

DiBiase, Andrew T. ^{[2
]}

Patel, Shruti ^{[3
]}

Stephens, Rachel ^{[3
]}

Littlewood, Simon J. ^{[4
]}

Spencer, Richard J. ^{[5
]}

Frawley, Tom ^{[6
]}

Benson, Philip E. ^{[6
]}

Ireland, Anthony J. ^{[7
]}

Parvizi, Farnaz ^{[7
]}

Atack, Nikki ^{[8
]}

Kidner, Giles ^{[9
]}

Wojewodka, Gabriella ^{[10
]}

Ward, Christopher ^{[11
]}

Papageorgiou, Spyridon N. ^{[12
]}

Newton, Jonathon T. ^{[13
]}

Cobourne, Martyn T. ^{[1
]}

机构：

[1] Guys Hosp, Kings Coll London, Fac Dent Oral & Craniofacial Sci, Ctr Craniofacial Dev & Regenerat, Floor 27, London SE1 9RT, England

[2] William Harvey Hosp, Maxillofacial Unit, Kennington Rd, Ashford TN24 0LZ, Kent, England

[3] Kings Coll Hosp NHS Fdn Trust, Dept Orthodont, Bessemer Rd, London SE5 9RS, England

[4] St Lukes Hosp, Orthodont Dept, Little Horton Lane, Bradford BD5 0NA, W Yorkshire, England

[5] Pinderfields Gen Hosp, Orthodont Dept, Aberford Rd, Wakefield WF1 4DG, England

[6] Sch Clin Dent, Acad Unit Oral Hlth & Dev, Sheffield S10 2TA, S Yorkshire, England

[7] Royal United Hosp, Combe Pk, Bath BA1 3NG, Avon, England

[8] Bristol Dent Sch, Child Dent Hlth, Lower Maudlin St, Bristol BS1 2LY, Avon, England

[9] Stoke Mandeville Hosp, Orthodont Dept, Aylesbury HP17 8UZ, Bucks, England

[10] Guys Hosp, Kings Coll London, Fac Dent Oral & Craniofacial Sci FoDOCS, Room 365,Floor 25 Tower Wing, London SE1 9RT, England

[11] Guys Hosp, NIHR Clin Res Network CRN, 16th Floor BRC Fac,Guys Tower, London SE1 9RT, England

[12] Univ Zurich, Ctr Dent Med, Clin Orthodont & Pediat Dent, Plattenstr 11, CH-8032 Zurich, Switzerland

[13] Guys Hosp, Populat & Patient Hlth, Floor 18,Tower Wing, London SE1 9RT, England

来源：

TRIALS | 2022年 / 23卷 / 01期

关键词：

Maxillary central incisor; Supernumerary tooth; Orthodontic space opening; Orthodontic traction; Randomised clinical trial; Unerupted; Eruption; QUALITY-OF-LIFE; DISPLACED CANINES; PROGNOSIS; ERUPTION; CHILDREN; REMOVAL;

D O I：

10.1186/s13063-022-06711-0

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：10

共 28 条

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