Assessment of Extraction of Primary Canines in Treating Mesioangular Displaced Permanent Canines Using Cone Beam Computed Tomography (CBCT). A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- King Abdulaziz University
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Successful eruption of maxillary permanent canines into the dental arch
Study Overview
Brief Summary
This research project is important because there is no gold standard to rely on regarding the effect of the extraction of primary canines as an interceptive treatment for children with mesioangular displaced canines.
Further investigations are needed to assess the impact of extractions of primary canines approach on the eruption rate or change in position of mesioangular displaced canines by comparing to non-extraction control group in an attempt to overcome the deficiencies in study designs of previously published studies.
Detailed Description
Primary objective:
To assess the effect of interceptive extraction of the primary canine on success of eruption of the permanent canine or the change in the position of displaced canine radiographically in children with mesioangular displaced canine when compared to non-extraction control group
Secondary objectives:
- To evaluate the patient satisfaction and pain experience during treatment
- To assess the effect of interceptive extraction of the primary canine on the condition of the roots of neighboring teeth
- To evaluate the effect of stage of root development on the level of correction of permanent canine position radiographically over time when comparing unilateral mesioangular displaced canine subgroup with its contralateral control
- To identify the effect of independent variables on the outcome of interceptive treatment
Materials and Methods
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
Two investigators unaware of the group to which the patients belong will carry out all the measurements on CBCT scan. One investigator will crop the view of the extraction site to ensure blinding of the other investigator.
Eligibility Criteria
- Ages
- 9 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The following inclusion (eligibility) criteria have to be fulfilled by the patients participating in the study:
- •Age of patients at diagnosis should be between 9 and 12 years old
- •Presence of firm maxillary primary canines
- •Identification of maxillary unilateral or bilateral mesioangular displaced maxillary canine by clinical examination .
- •Canine position will be confirmed by means of horizontal tube shift following Clark's rule using two peripaical radiographs of the canine region.
Exclusion Criteria
- •Any systemic condition, craniofacial syndromes or cleft lip and/or palate.
- •Patients with previous or ongoing orthodontic treatment Imaging exclusion criteria will be checked at baseline and follow-up.
- •Severe canine displacement according to Power and Short (Power and Short, 1993). This includes complete overlap of the canine relative to adjacent incisor and beyond (Stage 3). Severe angulation relative to the midline. Canine crown vertical height is above the full length of adjacent incisors roots (see index below for illustrations).
- •Severe Resorption of adjacent teeth, grade 3 or 4 according to Ericson and Kurol at baseline or during the trial (Ericson and Kurol, 2000).
- •Presence of pathology surrounding the canine (such as cyst, supernumerary, odontome).
- •Closed apex of mesioangular displaced canine
Arms & Interventions
Extraction of primary canines only
A total of 43 patients with unilateral mesioangular displaced maxillary canines Interceptive treatment: Extraction of both maxillary primary canines will be held at baseline visit At Baseline (T0): Clinical examinatiion + CBCT scan and then both primary canines will be extracted At 6 month follow-up (T1): Clinical examination only At 12 month follow-up: Clinical examination +/- CBCT scan
Treatment Plan :
- If displaced canine is not erupted and no improvement in position radiographically is noticed, patient will be referred to orthodontic/oral surgery department
- If Canine is emerged to oral cavity: No further CBCT scan will be taken
- If Position of canine is improved radiographically: Follow up untill canine emerges, total observation time is 18 months
Intervention: Extraction of primary canines (Procedure)
Control group- no extraction
A total of 43 patients with unilateral mesioangular displaced maxillary canines At Baseline (T0): Clinical examinatiion + CBCT scan , no extraction At 6 month follow-up (T1): Clinical examination At 12 month follow-up: Clinical examination +/- CBCT scan
Treatment Plan :
- If displaced canine is not erupted and no improvement in position radiographically is noticed, patient will be referred to orthodontic/oral surgery department
- If Canine is emerged to oral cavity: No further CBCT scan will be taken
- If Position of canine is improved radiographically: Follow up untill canine emerges, total observation time is 18 months
Outcomes
Primary Outcomes
Successful eruption of maxillary permanent canines into the dental arch
Time Frame: 12 months
The successful outcome is the eruption of maxillary permanent canines within 12 months into the dental arch
Secondary Outcomes
- Successful improvement of permanent canine position radiographically(12 months)
Investigators
Najlaa Alamoudi
Professor Najlaa Alamoudi
King Abdulaziz University