Unerupted (impacted) maxillary incisor teeth with associated supernumerary tooth Oral Health
Conditions
Interventions
This is a multicentre randomised clinical trial consisting of two parallel groups with equal randomisation to detect the superiority of one intervention over the other.
Randomization of the particip
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 30/10/2025: 1. Aged between 8-12 (up to the day before their 13th 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 _____ Previous key 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effect of initial tooth position on time taken for the tooth to erupt measured using radiography to assess initial tooth position at baseline and time to eruption (as defined above) using assessment of the pretreatment orthopantomogram radiographic image taken at baseline and the time (days) taken for the tooth to erupt (T2) through observation for up to 6 months. 2. Time taken to align the unerupted tooth to the correct occlusal position measured as time to correct occlusal position assessed using observation for up to 6 months to calculate the time (days) between T2 (successful eruption of the maxillary incisor tooth at 6 months post-supernumerary removal) and T3 (correct occlusal position of the unerupted incisor tooth). 3. Gingival (gum line) aesthetics measured using a rating of crown length using a visual analog scale (VAS) and subjective judgments relating to the appearance of the operated maxillary central incisor by two groups of judges (layperson and professional) to assess intra-oral photographs taken at 3 months post-orthodontic appliance removal 4. Quality of Life measured using self-reported Oral Health Related-Quality of Life (OHRQoL) at baseline, 6, and 9 months | — |
Countries
England, United Kingdom
Outcome results
None listed