- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02796911
Comparative Study of Different Bone Grafts in Accelerating Tooth Movement
Effectiveness of Bovine Derived Xenograft Versus Bioactive Glass With Periodontally Accelerated Osteogenic Orthodontics in Adults
Objective: Periodontally accelerated osteogenic orthodontics(PAOO) will minimize treatment time. The current study will be carried to evaluate the effectiveness of different bone grafts with a modified, less invasive corticotomy technique in the treatment of adult patients with moderate crowding.
Subjects and Methods: Thirty orthodontic patients will be selected. Patients were randomly classified into three groups. Group I will be treated with a modified technique of corticotomy, whereas group II will be treated with the same technique combined with PAOO using bovine derived xenograft, and group III will be treated with the same technique combined with PAOO using with bioactive glass. The total duration of active orthodontic treatment will be estimated. Probing depth, bone density and root length will be also evaluated. The measurements will be recorded.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: Periodontally accelerated osteogenic orthodontics(PAOO) combines periodontal therapy with orthodontic therapy, which will minimize treatment time. The current study will be carried to evaluate the effectiveness of bovine derived xenograft versus bioactive glass with a modified, less invasive corticotomy technique in the treatment of adult patients with moderate crowding.
Subjects and Methods: Thirty orthodontic patients will be selected. Patients were randomly classified into three groups. Group I will be treated with a modified technique of corticotomy on the labial side only, whereas group II will be treated with the same technique combined with PAOO using bovine derived xenograft, and group III will be treated with the same technique combined with PAOO using with bioactive glass. The total duration of active orthodontic treatment will be estimated from the time of starting the active orthodontic treatment, immediately following the corticotomy procedure, to the time of debonding. Probing depth will be evaluated clinically whereas bone density and root length will be evaluated radiographically. The measurements will be recorded at day of surgery (baseline) (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Jeddah, Saudi Arabia, 21589
- King Abdelaziz University. Faculty of dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A moderate 4-5mm crowding of the lower anterior teeth
- Good oral hygiene
- Healthy systemic condition
Exclusion Criteria:
- previous orthodontic treatment
- Probing depth values exceeding 3 mm
- Radiographic evidence of bone loss
- Regular administration medication that affects bone metabolism such as prolonged use of corticosteroids, or bisphosphonates and NSAIDs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Corticotomy alone
Group I will be treated with a modified technique of corticotomy assisted orthodontic treatment (CAOT) alone
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|
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Experimental: Corticotomy + xenograft
group II (included 6 females and 5 males) that treated with CAOT combined with bovine derived xenograft (Biogen, Biotecksrl Fermi, Arcugraro VI, Italy);
|
group II will be treated with CAOT combined with bovine derived xenograft (Biogen, Biotecksrl Fermi, Arcugraro VI, Italy);
Other Names:
|
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Experimental: Corticotomy + bioactive glass
group III (included 7 females and 4 males) that treated with CAOT combined with bioactive glass (Bio-Glass, Excellence Pharm Inc., Egypt).
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group III will be treated with CAOT combined with bioactive glass (Bio-Glass, Excellence Pharm Inc., Egypt).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speed of tooth movement
Time Frame: Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
|
The total duration of active orthodontic treatment will be estimated in weeks from the time of starting the active orthodontic treatment, immediately following the corticotomy procedure, to the time of debonding.
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Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone density
Time Frame: Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
|
Bone density will be evaluated radiographically
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Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
|
|
Root length
Time Frame: Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
|
Root length will be evaluated radiographically
|
Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 029-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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