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Completed

NCT Number: NCT03396900

Periodontally Accelerated Osteogenic Orthodontics With BMP2

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, 509002, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Osteogenic protein

Conventional Corticotomy

Other

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

Other names: PAOO Surgery

Primary outcomes

  1. Orthodontic treatment duration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

SVS Institute of Dental Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2018
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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