Periodontally Accelerated Osteogenic Orthodontics With BMP2

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396900
• Other study ID #: SVSIDS/PERIO/2/2015
• Status: Completed
• Phase: Phase 2
• First received: December 27, 2017
• Last updated: January 4, 2018
• Start date: July 1, 2016
• Est. completion date: November 1, 2017

Study information

• Verified date: January 2018
• Source: SVS Institute of Dental Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion

Intervention

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

Locations

Country	Name	City	State
India	SVS Institute of Dental Sciences, Mahabubnagar	Hyderabad	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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