NCT03684525|UnknownDMC
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Sponsor study identifier
interventional
86
1 country
1
Study Start
November 28, 2017
Actual (reported)Primary Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2017
Actual (reported)November 28, 2017
Actual (reported)September 25, 2018
Actual (reported)December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Successful improvement of permanent canine position radiographically
12 months
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
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
King Abdulaziz University, Dental University Hospital
Jeddah, 21589, Saudi Arabia
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.
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.
Najlaa M Alamoudi, BDS MSc DSc
King Abdulaziz University, Faculty of Dentistry
First Submitted
October 10, 2017
First Posted
September 25, 2018
Study Start
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
NOLLA, C. 1960. The development of the Permanent Teeth. Journal of Dentistry of Children 27, 254-266.
November 28, 2017
Primary Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 25, 2018
Record last verified: 2018-09
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Source: ClinicalTrials.gov.
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