Optimum Micro-osteoperforations Accelerated Tooth Movement Interval
NCT ID: NCT02571348
Last Updated: 2016-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
36 participants
INTERVENTIONAL
2015-09-30
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The significance of the outcome is to determine optimum recommended interval for micro-osteopeforation which can be used to accelerate orthodontic tooth movement. By finding out the optimum interval, the investigator can come with a recommended interval of micro-osteoperforation which can be used routinely in patients to fasten orthodontic tooth movement.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
2. SAMPLE SIZE CALCULATION Sample size calculation is based on a type 1 error frequency of 5% and the power of the statistical test set at 90% ( P = 0.9, B = 0.1 ) This is based on animal study as a guide to detect at least 50% difference in the rate of tooth movement. ( Teixeira CC et al.,2010). The sample size was calculated based on a formula described by Lisa Kuramoto from Vancouver Coastal Health Research Institute. Total participant needed with be 30 with minimum of 10 participants per group. We anticipate 20% drop-outs based on previous study. Thus, a minimum of 36 participants will be recruited.
4\. ETHICAL APPROVAL Approval for the conduct of this study had been obtained from Medical Ethics Committee, University of Malaya 5. RANDOMIZATION This study will be conducted by one orthodontic resident together with one orthodontic Consultant from Faculty of Dentistry, University Malaya, who is the main supervisor of this study. A simple randomization method will be employed to assign patient into experimental site and also the for the frequency interval of micro-osteoperforation.
6\. INTERVENTION Sequence of events during clinical trial is as follows:-
1. Diagnostic record taking (Study models, Photographs, and x-ray)
2. Randomization for experimental sites in maxilla and mandible \& randomization for interval of micro-osteoperforation (Group 1: 4weeks maxilla \& 8weeks mandible, Group 2: 8weeks maxilla \& 12weeks mandible, Group 3: 12 weeks maxilla \& 4 weeks mandible)
3. Treatment planning with Orthodontic Consultant
4. Placement of TADs bilaterally in maxilla and mandible \& Clinical calibration for inter-observer error
5. Referral for extraction of 14,24,34 and 44 (Extraction must be done within 2 weeks after insertion of TADs)
6. One month after extraction, Banding and Bonding of upper and lower preadjusted edgewise fixed appliances (MBT prescription 0.022"x 0.028" slot).
7. Arch wire sequence for levelling and aligning are as follows:-
* Upper and lower 0.014 NiTi Arch wire
* Upper and lower 0.018 NiTi Arch wire
* Upper and lower 17 x 25 NiTi Arch wire
* Upper and lower 19 x 25 SS Arch wire
* Dead coil will be placed to maintain the extraction space of premolars
* Interval between each arch wire sequence is 6 weeks
8. One month after the insertion of working arch wire, micro-osteoperforations will be performed \& Inter-obverver error measurement will be done 2 weeks after insertion of working arch wire and on the day of mirco-osteoperforations.
9. Three micro-osteoperforations will be placed at the buccal aspect on the buccal cortical bone at the site of premolar extraction(experimental site only) and both canine will be retracted bilaterally with NiTi Coil Spring.
10. Participants will be given questionnaire after the procedure and the questionnaire will be collected the following visit 11 From now onwards, participants will be reviewed at their respective interval. Either 4,8 or 12 weeks interval.
12\. This is the critical period of this study in which micro-osteoperforations will be performed and questionnaire will be given to participants.
13\. Data collection will be conducted for a period of 16weeks(4 months) - during canine retraction
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
4 weeks and 8 weeks
Micro-osteoperforation will be done on either side of the maxilla at 4 weeks interval and the contralateral site will be the control. In mandible, micro-osteoperforation will be done every 8 weeks and the contralateral site will serve as the control
micro-osteoperforation
micro-osteoperforation with mini implant at different interval
8 weeks and 12 weeks
Micro-osteoperforation will be done on either side of the maxilla at 8 weeks interval and the contralateral site will be the control. In mandible, micro-osteoperforation will be done every 12 weeks and the contralateral site will serve as the control
micro-osteoperforation
micro-osteoperforation with mini implant at different interval
12 weeks and 4 weeks
Micro-osteoperforation will be done on either side of the maxilla at 12 weeks interval and the contralateral site will be the control. In mandible, micro-osteoperforation will be done every 4 weeks and the contralateral site will serve as the control
micro-osteoperforation
micro-osteoperforation with mini implant at different interval
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
micro-osteoperforation
micro-osteoperforation with mini implant at different interval
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Average vertical facial proportions
* No systemic disease
* Good oral hygiene
* No history of periodontal therapy
* No current active periodontal disease
Exclusion Criteria
* Systemic disease especially on long term use of antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroid and calcium channel blockers
* Poor oral hygiene for more than 3 visits
* Past periodontal disease
* Current periodontal disease
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Malaya
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wey Mang Check
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry, University of Malaya
Jennifer Geraldine Doss
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry, University of Malaya
Saritha Sivarajan
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry, University of Malaya
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Dentistry, University of Malaya
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Alikhani M, Khoo E, Alyami B, Raptis M, Salgueiro JM, Oliveira SM, Boskey A, Teixeira CC. Osteogenic effect of high-frequency acceleration on alveolar bone. J Dent Res. 2012 Apr;91(4):413-9. doi: 10.1177/0022034512438590. Epub 2012 Feb 14.
Teixeira CC, Khoo E, Tran J, Chartres I, Liu Y, Thant LM, Khabensky I, Gart LP, Cisneros G, Alikhani M. Cytokine expression and accelerated tooth movement. J Dent Res. 2010 Oct;89(10):1135-41. doi: 10.1177/0022034510373764. Epub 2010 Jul 16.
Krishnan V, Davidovitch Z. On a path to unfolding the biological mechanisms of orthodontic tooth movement. J Dent Res. 2009 Jul;88(7):597-608. doi: 10.1177/0022034509338914.
Krishnan V, Davidovitch Z. Cellular, molecular, and tissue-level reactions to orthodontic force. Am J Orthod Dentofacial Orthop. 2006 Apr;129(4):469.e1-32. doi: 10.1016/j.ajodo.2005.10.007.
Ren Y, Kuijpers-Jagtman AM, Maltha JC. Immunohistochemical evaluation of osteoclast recruitment during experimental tooth movement in young and adult rats. Arch Oral Biol. 2005 Dec;50(12):1032-9. doi: 10.1016/j.archoralbio.2005.04.005. Epub 2005 Jun 15.
Long H, Pyakurel U, Wang Y, Liao L, Zhou Y, Lai W. Interventions for accelerating orthodontic tooth movement: a systematic review. Angle Orthod. 2013 Jan;83(1):164-71. doi: 10.2319/031512-224.1. Epub 2012 Jun 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DF CD1412/0089(P)
Identifier Type: -
Identifier Source: org_study_id