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Periodontally Accelerated Osteogenic Orthodontics With BMP2

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03396900
Enrollment
30
Registered
2018-01-11
Start date
2016-07-01
Completion date
2017-11-01
Last updated
2018-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion

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.

Interventions

DRUGRhBMP-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.

OTHERConventional Corticotomy

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

Sponsors

SVS Institute of Dental Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Orthodontic treatment durationUp to 6 monthsPeriodic 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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026