Assessment of Extraction of Primary Canines in Treating Mesioangular Displaced Permanent Canines

NCT03684525 | Unknown DMC

• 1 other identifier: KingAbdulazizUniversity
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Displaced Tooth

Keywords

Mesioangular displaced canines; Interceptive treatment

Outcome Measures

Primary Outcomes (1)

• Successful eruption of maxillary permanent canines into the dental arch

  The successful outcome is the eruption of maxillary permanent canines within 12 months into the dental arch

  12 months

Secondary Outcomes (1)

• Successful improvement of permanent canine position radiographically

  12 months

Study Arms (2)

Extraction of primary canines only

EXPERIMENTAL

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

Procedure: Extraction of primary canines

Control group- no extraction

NO INTERVENTION

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

Interventions

Extraction of primary canines PROCEDURE

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

Extraction of primary canines only

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Any systemic condition, craniofacial syndromes or cleft lip and/or palate.
• 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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University, Dental University Hospital

Jeddah, 21589, Saudi Arabia

RECRUITING

Related Publications (10)

• American Academy of Oral and Maxillofacial Radiology. Clinical recommendations regarding use of cone beam computed tomography in orthodontics. [corrected]. Position statement by the American Academy of Oral and Maxillofacial Radiology. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Aug;116(2):238-57. doi: 10.1016/j.oooo.2013.06.002.

  PMID: 23849378 BACKGROUND

• Bennett ME, Tulloch JF, Vig KW, Phillips CL. Measuring orthodontic treatment satisfaction: questionnaire development and preliminary validation. J Public Health Dent. 2001 Summer;61(3):155-60. doi: 10.1111/j.1752-7325.2001.tb03383.x.

  PMID: 11603319 BACKGROUND

• Donner A, Birkett N, Buck C. Randomization by cluster. Sample size requirements and analysis. Am J Epidemiol. 1981 Dec;114(6):906-14. doi: 10.1093/oxfordjournals.aje.a113261. No abstract available.

  PMID: 7315838 BACKGROUND

• Ericson S, Kurol J. Incisor root resorptions due to ectopic maxillary canines imaged by computerized tomography: a comparative study in extracted teeth. Angle Orthod. 2000 Aug;70(4):276-83. doi: 10.1043/0003-3219(2000)0702.0.CO;2.

  PMID: 10961776 BACKGROUND

• Feldmann I, List T, John MT, Bondemark L. Reliability of a questionnaire assessing experiences of adolescents in orthodontic treatment. Angle Orthod. 2007 Mar;77(2):311-7. doi: 10.2319/0003-3219(2007)077[0311:ROAQAE]2.0.CO;2.

  PMID: 17319767 BACKGROUND

• Ludlow JB, Timothy R, Walker C, Hunter R, Benavides E, Samuelson DB, Scheske MJ. Effective dose of dental CBCT-a meta analysis of published data and additional data for nine CBCT units. Dentomaxillofac Radiol. 2015;44(1):20140197. doi: 10.1259/dmfr.20140197.

  PMID: 25224586 BACKGROUND

• Ludlow JB, Walker C. Assessment of phantom dosimetry and image quality of i-CAT FLX cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):802-17. doi: 10.1016/j.ajodo.2013.07.013.

  PMID: 24286904 BACKGROUND

• Naoumova J, Kjellberg H, Palm R. Cone-beam computed tomography for assessment of palatal displaced canine position: a methodological study. Angle Orthod. 2014 May;84(3):459-66. doi: 10.2319/070913-502.1. Epub 2013 Oct 25.

  PMID: 24160995 BACKGROUND

• Naoumova J, Kurol J, Kjellberg H. Extraction of the deciduous canine as an interceptive treatment in children with palatal displaced canines - part I: shall we extract the deciduous canine or not? Eur J Orthod. 2015 Apr;37(2):209-18. doi: 10.1093/ejo/cju040. Epub 2014 Sep 22.

  PMID: 25246604 BACKGROUND

• NOLLA, C. 1960. The development of the Permanent Teeth. Journal of Dentistry of Children 27, 254-266.

  BACKGROUND

Study Officials

• Najlaa M Alamoudi, BDS MSc DSc

  King Abdulaziz University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Najlaa M Alamoudi, BDS MSc DSc

CONTACT

00966126402000; nalamoudi@kau.edu.sa

Reem K Naaman, BDs MSc

CONTACT

+966126402000; dr.reem.naaman@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Najlaa Alamoudi

Model Details: Randomized controlled clinical trial following CONSORT guidelines. Patients to be allocated equally to two groups: one treatment group and one control group as follows: * Group 1: Extraction of primary maxillary canines group (EG) * Group 2: Control group - no extraction (CG)

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: September 25, 2018
• Study Start: November 28, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: September 25, 2018

Record last verified: 2018-09

Locations

SA (1)