DFDBA and Amniotic Membrane in the Treatment of Periodontal Osseous Defects

Krishnadevaraya College of Dental Sciences & Hospital

Status and phase: Unknown; Phase 4

Conditions: Periodontal Intrabony Defects

Treatments: Procedure: OFD+ DFDBA; Procedure: OFD+ DFDBA+ AM

Study type: Interventional

Funder types: Other

Identifiers

NCT02635529

02_D012_44443

Details and patient eligibility

About

Amniotic membrane may be considered as a biologically active scaffold, which in combination with Bone Replacement Grafts (BRG) can be widely used to reconstruct periodontal Intrabony Defects (IBDs), due to the presence of stem cells and growth factors. The goal of the present study was to evaluate if a biologic AM in combination with DFDBA applied in periodontal IBDs would enhance the regeneration of periodontium.

Full description

Periodontitis is a bacterially induced inflammatory disease of the supporting tissues of the teeth. It is one of the major dental diseases that affect human populations worldwide and has a huge economic impact on national health care systems.The consequence of periodontitis is commonly the formation of intrabony defects.Intrabony defects are more amenable for regenerative procedures. Periodontal regeneration remains a fundamental therapeutic goal for the preservation of teeth through the restoration of health, function, and esthetics of the periodontium. Several treatment procedures like open flap debridement (OFD), autogenous bone replacement bone grafts (BRG), guided tissue regeneration (GTR), bioactive agents like EMD, rhPDGF-BB, laser assisted regeneration (LAR) have shown histologic proof of principle that the periodontal ligament apparatus can be regenerated in human studies. Intrabony defects with the depth of >3 mm and radiographic defect angle ≤ 25 are amenable for periodontal regeneration. DFDBA has stood the test of time and has shown consistent good quality patient oriented evidence in achieving periodontal regeneration with long term stability. GTR techniques have shown added advantage of space maintenance, clot stability, guided cell population, epithelial cell occlusion and the combination therapies. Periodontal regeneration with GTR and BRG demonstrates better results as compared with GTR alone. More recently in the realm of reconstructive biology, the concept of Tissue engineering (TE) has been introduced which utilizes mechanical, cellular or biologic mediators to facilitate reconstruction/regeneration of a particular tissue.

The combination of this novel biologic membrane AM and the already established BRG-DFDBA can be an added advantage in treatment of IBDs. To the best of the investigators knowledge only one clinical trial reports this combination therapy in the scientific literature. There is a need for further research in this area.

Enrollment: 10 estimated patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age group of 25-45 years
• Moderate periodontitis with pocket probing depth more than 6mm
• Bilaterally similar intrabony defects
• Systemically healthy patients
• Vital or endodontically treated teeth
• Good compliance

Exclusion criteria

• Medically compromised
• Pregnant and lactating women
• Smoking
• Teeth with mobility and furcation involvement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

OFD + DFDBA

Active Comparator group

Description:

Intrabony defects treatment was carried out with OFD + DFDBA

Treatment:

Procedure: OFD+ DFDBA

OFD+DFDBA+AM

Active Comparator group

Description:

Intrabony defects treatment was carried out with OFD + DFDBA+ AM

Treatment:

Procedure: OFD+ DFDBA+ AM