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Comparative Study of Different Bone Grafts in Accelerating Tooth Movement

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ClinicalTrials.gov Identifier: NCT02796911
Recruitment Status : Unknown
Verified June 2016 by Maha A. Bahammam, King Abdulaziz University.
Recruitment status was:  Recruiting
First Posted : June 13, 2016
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Maha A. Bahammam, King Abdulaziz University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Orthodontics Drug: Xenograft Drug: Bioactive glass Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Bovine Derived Xenograft Versus Bioactive Glass With Periodontally Accelerated Osteogenic Orthodontics in Adults
Study Start Date : September 2015
Estimated Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Corticotomy alone
Group I will be treated with a modified technique of corticotomy assisted orthodontic treatment (CAOT) alone
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);
Drug: Xenograft
group II will be treated with CAOT combined with bovine derived xenograft (Biogen, Biotecksrl Fermi, Arcugraro VI, Italy);
Other Name: bovine derived xenograft

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).
Drug: Bioactive glass
group III will be treated with CAOT combined with bioactive glass (Bio-Glass, Excellence Pharm Inc., Egypt).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796911


Locations
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Saudi Arabia
King Abdelaziz University. Faculty of dentistry Recruiting
Jeddah, Saudi Arabia, 21589
Contact: Maha A Bahammam, DSc    +9660126402000 ext 20799    mbahammam@kau.edu.sa   
Sponsors and Collaborators
King Abdulaziz University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maha A. Bahammam, Associate Professor and Consultant of Periodontology, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT02796911     History of Changes
Other Study ID Numbers: 029-16
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors