Accelerated Tooth Movement Interval Clinical Trial
Official title:
Optimum Micro-osteoperforations Accelerated Tooth Movement Interval, Related Pain Perception and Impact to Daily Functions - A Randomized Controlled Trial
Verified date | December 2016 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | Malaysia: Institutional Review Board |
Study type | Interventional |
This study is intended to investigate the optimum interval between micro-osteoperforations
to accelerate orthodontic tooth movement. Overall, the investigator will be comparing the
rate of tooth movement between micro-osteoperforated site and non micro-osteoperforated
site. Next, the investigator will be comparing the rate of orthodontic tooth movement for
micro-osteperforation performed at 4, 8 and 12 weeks' intervals. In addition, the
investigator will be evaluating the pain intensity and impact of pain on quality of life
during different intervals of micro-osteoperforations at 4, 8 and 12 weeks. Finally, the
investigator will be comparing the rate of orthodontic tooth movement between maxilla and
mandible.
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.
Status | Active, not recruiting |
Enrollment | 36 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Molar Class I malocclusion, molar Class II & III < ½ unit, requiring extraction of all four permanent first premolar and maximum anchorage control with temporary anchorage device (TAD) - Average vertical facial proportions - No systemic disease - Good oral hygiene - No history of periodontal therapy - No current active periodontal disease Exclusion Criteria: - Vertical skeletal discrepancies eg high angle and low angle - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Malaysia | Faculty of Dentistry, University of Malaya | Kuala Lumpur | Wilayah Persekutuan |
Lead Sponsor | Collaborator |
---|---|
University of Malaya |
Malaysia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | rate of orthodontic tooth movement between micro osteoperforated site and non micro-osteoperforated site. | through study completion, an average of 2 years | No | |
Secondary | Rate of orthodontic tooth movement between maxilla and mandible. | through study completion, an average of 2 years | No | |
Secondary | Rate of orthodontic tooth movement when micro-osteperforation performed at 4, 8 and 12 weeks intervals. | through study completion, an average of 2 years | No | |
Secondary | Pain intensity and impact of pain on patient's daily functions during different intervals of micro-osteoperforations at 4, 8 and 12 weeks using questionnaire. | through study completion, an average of 2 years | No |