Periodontally Accelerated Osteogenic Orthodontics With BMP2

Periodontally Accelerated Osteogenic Orthodontics Combined With Recombinant Human Bone Morphogenetic Protein-2: An Outcome Assessment

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Drug: RhBMP-2 Protein, Recombinant; Other: Conventional Corticotomy

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 509002
      • SVS Institute of Dental Sciences, Mahabubnagar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: SVSIDS/PERIO/2/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Published data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No