Periodontally Accelerated Osteogenic Orthodontics With BMP2

Phase 2

Completed

• Conditions: Malocclusion
• Interventions: Drug: RhBMP-2 Protein, Recombinant; Other: Conventional Corticotomy

• Registration Number: NCT03396900
• Lead Sponsor: SVS Institute of Dental Sciences

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.

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-08-01
• Study Completion: 2017-11-01
• Study First Submitted: 2017-12-27
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-04
• Last Update Submitted: 2018-01-04
• Study First Posted: 2018-01-11
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RhBMP-2 Protein, Recombinant	RhBMP-2 Protein, Recombinant	15 subjects treated with corticotomy with rhBMP-2 (C+BMP)
Conventional Corticotomy	Conventional Corticotomy	15 subjects treated with conventional corticotomy (C) as in the PAOO protocol

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

SVS Institute of Dental Sciences, Mahabubnagar; 🇮🇳 Hyderabad, Andhra Pradesh, India