Periodontally Accelerated Osteogenic Orthodontics With BMP2

NCT03396900 | Completed Phase 2

• 1 other identifier: SVSIDS/PERIO/2/2015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 months

Study Arms (2)

RhBMP-2 Protein, Recombinant

ACTIVE COMPARATOR

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

Drug: RhBMP-2 Protein, Recombinant

Conventional Corticotomy

EXPERIMENTAL

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

Other: Conventional Corticotomy

Interventions

RhBMP-2 Protein, Recombinant DRUG

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.

Also known as: Osteogenic protein

RhBMP-2 Protein, Recombinant

Conventional Corticotomy OTHER

A conventional PAOO Surgical procedure will be performed for individuals in this arm

Also known as: PAOO Surgery

Conventional Corticotomy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Smokers and subjects with severe crowding of anterior teeth, periodontitis and systemic diseases were excluded from the study.

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, 509002, India

Location

MeSH Terms

Conditions

Malocclusion

Interventions

recombinant human bone morphogenetic protein-2

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Madhukar R Rachala, MDS

  SVS Institute of Dental Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 11, 2018
• Study Start: July 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)