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Clinical Trials/NCT03435653
NCT03435653UnknownNot Applicable

Comparative Clinical and Radiographic Evaluation of Demineralized Freeze-dried Bone Allograft With and Without Decortication in the Treatment of Periodontal Intrabony Defects - a Randomized Controlled Clinical Study.

Postgraduate Institute of Dental Sciences Rohtak2 sites in 1 country36 target enrollmentStarted: December 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
36
Locations
2
Primary Endpoint
Radiographic Bone fill

Study Overview

Brief Summary

To compare clinically and radiographically the efficacy of demineralized freeze-dried bone allograft with and without decortication in the treatment of periodontal intrabony defects assessed by gain in clinical attachment, reduction of pocket depth and radiographic bone fill.To evaluate clinically and radiographically the regenerative potential of demineralized freeze-dried bone graft (DFDBA) material in periodontal intrabony defects.To evaluate clinically and radiographically the regenerative potential of demineralized freeze-dried bone graft (DFDBA) when used in combination with decortication in periodontal intrabony defects.

Detailed Description

INTRODUCTION Periodontitis is a multifactorial infectious disease with microbial plaque as initiator that triggers inflammatory response in the periodontal tissue. As the disease progresses, symptoms may include bleeding gums, periodontal abscesses, increased tooth mobility due to the loss of bone support, tooth migration, exposure of the root surface, and tooth loss. Current periodontal therapy is directed towards establishing a healthy periodontium by attempting to resolve the tissue inflammation induced by bacterial plaque and its products and the restitution of the anatomic defects caused by the disease process. There are many outcomes possible from the periodontal therapy depending upon the goals, the type of therapy, and the methods utilized to evaluate it. These can range from halting the destructive process, maintaining an area to repair a defect and/or regeneration.

Melcher described the concept of selective cell repopulation of defects to enhance healing.The guided tissue regeneration (GTR) technique excludes faster growing epithelial and connective tissue cells with barriers and bone grafts to allow slower moving pluripotential and osteogenic cells to repopulate the treated site. To attain horizontal and/or vertical bone augmentation beyond the envelope of skeletal bone, four principles need to be met: primary wound closure, angiogenesis to provide necessary blood supply and undifferentiated mesenchymal cells, space maintenance and stability of the blood clot .The ultimate goal of the regenerative periodontal therapy is to restore the lost periodontal tissues including cementum, periodontal ligament and alveolar bone.

The current regenerative therapy includes the use of bone grafts, guided tissue regeneration (GTR), bioactive agents like Enamel matrix derivative (EMD) and laser assisted regeneration. The clinical periodontal regenerative treatments focus on the utilization of bone grafts that can be obtained from the same individual (autografts), from different individual of the same species (allografts) or from a different species (xenografts). Apart from these synthetic bone grafts are also available (alloplasts).

Allografts are bone grafts taken for transplantation from one human to another. There are two types of allografts available including freeze-dried bone allograft and demineralized freeze-dried bone allograft (DFDBA). Demineralized freeze-dried bone allograft is a graft that possesses osteoconductive and osteoinductive properties. Demineralization process of the graft exposes the bone inductive properties located in the bone matrix such as bone morpogenetic protein-2(BMP2) and bone morpogenetic protein-7 (BMP 7) that aid in mesenchymal cell migration, attachment and osteogenesis when implanted in well vascularised bone. It has shown to regenerate bone as well as cementum and periodontal ligament in treatment of periodontal osseous defects at the same time eliminates the need for a second surgical site. When used for periodontal regeneration, DFDBA may not only lead to clinical improvements in terms of pocket probing depth (PPD) reduction and gain of clinical attachment level (CAL), but also lead to formation of new connective tissue attachment and new alveolar bone.

Several authors have advocated the use intramarrow penetration (IMP), also known as decortication, as a part of guided bone regeneration procedure. Osteoblasts that form new bone are derived from periosteum, endosteum, and undifferentiated pluripotential mesenchymal cells in the bone marrow. After the elevation of mucoperiosteal flap when the barrier is placed, the contribution of periosteum to GBR procedure is lost. Along with this, a bone graft placed on the cortical bone also interferes with the entry of undifferentiated pluripotential mesenchymal cells from the endosteum and bone marrow towards the GBR-treated site.Therefore drilling holes through cortical bone into more vascular cancellous bone induces bleeding and organised clot releases cytokines and growth factors which attracts the blood vessels, osteoblasts, and pluripotential cells to the grafted sites. It also enhance the physical connection between the bone graft and recipient site to improve its stability and provide firm linking for newly generated bone.Studies have shown that open flap debridement (OFD) combined with decortication produces positive result outcomes in regenerative periodontal treatment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age-28-60 years , patients with chronic periodontitis according to criteria of Armitage GC classification system for periodontal diseases and conditions
  • Presence of 2-, 3-, or combined 2-3-wall intrabony defect ≥ 3 mm deep assessed by transgingival probing and intraoral periapical radiograph, to be confirmed after flap elevation.
  • Test tooth and adjoining teeth testing vital, should be free of caries or inadequate restorations.
  • Non smokers
  • Completed etiological periodontal therapy (oral hygiene instructions and scaling and root-planing with Full-Mouth Bleeding Score FMBS < 20% and plaque index score<1 [Silness and Loe 1964]33).
  • TOOTH OR DEFECT ELIGIBILITY CRITERIA-
  • 2-, 3- or combined 2,3-wall intrabony defect.
  • Pocket probing depth ≥ 5 mm
  • CAL ≥ 5 mm.
  • Tooth mobility < grade 1

Exclusion Criteria

  • Systemic illness known to affect the periodontium or outcome of periodontal therapy.
  • Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
  • Patient allergic to study medications
  • Pregnant or lactating mothers.
  • Tooth with 1wall intrabony defect.
  • Grade2, grade 3 mobile teeth.
  • Defects extending to a root furcation area.
  • Unrestorable tooth.
  • Fractured/perforated roots.
  • Developing permanent tooth.
  • Endodontically treated tooth.
  • Presence of non working interferences.

Outcomes

Primary Outcomes

Radiographic Bone fill

Time Frame: 12 months

gain in bone level in mm

CAL

Time Frame: 12 months

clinical attachment level in mm

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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