Clincosm LogoSign in Get a demo

Periodontally Accelerated Osteogenic Orthodontics With BMP2

Sponsor
SVS Institute of Dental Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03396900
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
16
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

rhBMP-2 has the potential to function as a regenerative material in periodontally accelerated osteogenic orthodontics (PAOO). This study aimed to assess the effects of PAOO with BMP-2 on outcomes such as treatment period, bone density, healing and pain.

Condition or Disease Intervention/Treatment Phase
  • Drug: RhBMP-2 Protein, Recombinant
  • Other: Conventional Corticotomy
 Phase 2

Detailed Description

Subjects were randomly assigned into each of the following experimental groups; C+BMP:

corticotomy with 0.5 μg/mL rhBMP-2 and C: corticotomy only. Clinical parameters included recording the duration of treatment period, visual analogue scale (VAS) scores and early healing index (EHI) scores. The evaluation of bone density was performed at baseline, 3 months and 6 months by using RVG.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is a randomized controlled clinical trial where systemically healthy individuals undergoing orthodontic therapy and willing to participate in the study were referred from the Department of Orthodontics and were followed up over a 6 month period after treatment.This study is a randomized controlled clinical trial where systemically healthy individuals undergoing orthodontic therapy and willing to participate in the study were referred from the Department of Orthodontics and were followed up over a 6 month period after treatment.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
The orthodontist (HA) who performed the relevant treatment after PAOO was different from the orthodontist (MRR) randomizing the subjects into C or C+BMP groups and hence was blinded to the treatment received by the patient. One periodontist performed the PAOO surgeries (KM) and another periodontist (RVC) blinded to the therapy received by the subjects recorded the clinical and radiographic data pertinent to the study. The blind was not broken until the end of study period.
Primary Purpose:
Treatment
Official Title:
Periodontally Accelerated Osteogenic Orthodontics Combined With Recombinant Human Bone Morphogenetic Protein-2: An Outcome Assessment
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: RhBMP-2 Protein, Recombinant

15 subjects treated with corticotomy with rhBMP-2 (C+BMP)

Drug: RhBMP-2 Protein, Recombinant
Bone morphogenetic proteins (BMPs) are a category of proteins that are involved in bone formation and repair. Among these, BMP-2 is one of the most potent members of the BMP family and has been used for correcting intrabony, supraalveolar, furcation, and fenestration defects due to its osteoinductive property. BMP's are also essential for differentiation of osteoclasts, but their role in this process remains unclear. Treatment of osteoclasts with exogenous BMP-2 directly enhances RANKL-stimulated differentiation of osteoclast precursors in vitro and stimulates survival and resorptive activity of mature osteoclasts that accelerates the tooth movement.
Other Names:
  • Osteogenic protein

    		•
    Experimental: Conventional Corticotomy

    15 subjects treated with conventional corticotomy (C) as in the PAOO protocol

    Other: Conventional Corticotomy
    A conventional PAOO Surgical procedure will be performed for individuals in this arm
    Other Names:
  • PAOO Surgery

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Orthodontic treatment duration [Up to 6 months]

      Periodic recall of patients for every two weeks was done to assess the amount of crowding relieved by using digital Vernier calipers and photographs. The time taken to unravel the crowding in the pretreatment and post treatment study models and photographs was recorded.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 30 subjects with moderate crowding of lower incisors based upon Little's index and willing to undergo undergoing orthodontic treatment with extraction therapy of lower 1st premolars and PAOO were included in the study.
    Exclusion Criteria:
    • Smokers and subjects with severe crowding of anterior teeth, periodontitis and systemic diseases were excluded from the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SVS Institute of Dental Sciences, Mahabubnagar Hyderabad Andhra Pradesh India 509002

    Sponsors and Collaborators

    • SVS Institute of Dental Sciences

    Investigators

    • Study Chair: Madhukar R Rachala, MDS, SVS Institute of Dental Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr R Viswa Chandra, Investigator, SVS Institute of Dental Sciences
    ClinicalTrials.gov Identifier:
    NCT03396900
    Other Study ID Numbers:
    • SVSIDS/PERIO/2/2015
    First Posted:
    Jan 11, 2018
    Last Update Posted:
    Jan 11, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Malocclusion

    Study Results

    No Results Posted as of Jan 11, 2018