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Periodontally Accelerated Osteogenic Orthodontics With BMP2

Primary Purpose

Malocclusion

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
RhBMP-2 Protein, Recombinant
Conventional Corticotomy
Sponsored by
SVS Institute of Dental Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • SVS Institute of Dental Sciences, Mahabubnagar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

RhBMP-2 Protein, Recombinant

Conventional Corticotomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Orthodontic treatment duration
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.

Secondary Outcome Measures

Full Information

First Posted
December 27, 2017
Last Updated
January 4, 2018
Sponsor
SVS Institute of Dental Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03396900
Brief Title
Periodontally Accelerated Osteogenic Orthodontics With BMP2
Official Title
Periodontally Accelerated Osteogenic Orthodontics Combined With Recombinant Human Bone Morphogenetic Protein-2: An Outcome Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SVS Institute of Dental Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RhBMP-2 Protein, Recombinant
Arm Type
Active Comparator
Arm Description
15 subjects treated with corticotomy with rhBMP-2 (C+BMP)
Arm Title
Conventional Corticotomy
Arm Type
Experimental
Arm Description
15 subjects treated with conventional corticotomy (C) as in the PAOO protocol
Intervention Type
Drug
Intervention Name(s)
RhBMP-2 Protein, Recombinant
Other Intervention Name(s)
Osteogenic protein
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Corticotomy
Other Intervention Name(s)
PAOO Surgery
Intervention Description
A conventional PAOO Surgical procedure will be performed for individuals in this arm
Primary Outcome Measure Information:
Title
Orthodontic treatment duration
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhukar R Rachala, MDS
Organizational Affiliation
SVS Institute of Dental Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
SVS Institute of Dental Sciences, Mahabubnagar
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
509002
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Published data will be shared

Learn more about this trial

Periodontally Accelerated Osteogenic Orthodontics With BMP2

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