DFDBA and Amniotic Membrane in the Treatment of Periodontal Osseous Defects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Periodontal Intrabony Defects

Intervention / Treatment
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* Procedure: OFD+ DFDBA
* Procedure: OFD+ DFDBA+ AM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OFD + DFDBA<br>Intrabony defects treatment was carried out with OFD + DFDBA | Procedure: OFD+ DFDBA<br>* After Phase I therapy, patient's were assigned for OFD+DFDBA group. Mucoperiosteal flap were reflected.After Open Flap Debridement (OFD), DFDBA graft was placed for the treatment of intrabony defects.<br>|
| Active Comparator: OFD+DFDBA+AM<br>Intrabony defects treatment was carried out with OFD + DFDBA+ AM | Procedure: OFD+ DFDBA+ AM<br>* After Phase I therapy, patient's were assigned for OFD+DFDBA + AM group. Mucoperiosteal flap were reflected. After Open Flap Debridement (OFD). DFDBA and AM was placed for the treatment of intrabony defects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level (CAL) | Clinical attachment level measured in mm from cementoenamel junction to base of the pocket) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index | Plaque index is measured for periodontal health | 1 year | 
| Gingival index | Gingival index is measured for periodontal health | 1 year | 
| Bleeding index | Bleeding index is measured for periodontal health | 1 year | 
| Pocket Probing depth | Pocket probing depth level measured in mm from gingival margin to base of the pocket) | 1 year | 
| Bone Fill | Bone fill measured in mm in radiographs from alveolar crest to base of the pocket | 1 year |