Periodontal Intrabony Defects Clinical Trial
Official title:
A Clinical and Radiographic Evaluation of DFDBA (Demineralised Freeze Dried Bone Allograft) With Amniotic Membrane (AM) in the Treatment of Periodontal Osseous Defects-12 Month Randomized Controlled Clinical Trial
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02949557 -
DFDBA and Xenograft (Cerabone)TM With Decortication in Intrabony Defects
|
Phase 4 | |
| Not yet recruiting |
NCT05177198 -
Effects of Modified Minimally Invasive Surgical Technique With Clindamycin Augmented Platelet-rich Fibrin Versus Platelet-rich Fibrin Alone for Management of Periodontal Intrabony Defects.
|
N/A |