Effect of Amnion Membrane With and Without Taurine on GCF TNF α Level.

Study Overview
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Brief Summary
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45 sites in 15 patients with periodontal pockets ≥ 5mm were selected. These selected sites were divided into 3 groups as Group A, B and C.

Detailed Description
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Group A (Control): 15 sites received only SRP, Group B: 15 sites received SRP with subgingival placement of amnion membrane, Group C: 15 sites received SRP with subgingival placement of Amnion membrane hydrated with Taurine.

Official Title
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Efficacy of Subgingivally Placed Amnion Membrane With and Without Taurine as an Adjunct to Scaling and Root Planing in the Treatment of Chronic Periodontitis

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: Scaling and root planing
* Biological: Amnion membrane
* Drug: Taurine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: •Systemically healthy patients with sites showing probing depth (PD) ≥ 5mm, clinical attachment level (CAL) ≥ 4 mm, and vertical bone loss ≥ 3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months Exclusion Criteria: Any systemic disease that could influence the outcome of periodontal therapy. Smokers, alcoholics & patients with other adverse habits. Pregnant or nursing women. Any known allergy or hypersensitivity to any product used in the study. Patients on long term systemic therapy (antibiotics, anti-inflammatory and any other).

Ages Eligible for Study
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Minimum Age: 29 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Group A (Control): 15 sites received only SRP, Group B: 15 sites received SRP with subgingival placement of amnion membrane, Group C: 15 sites received SRP with subgingival placement of Amnion membrane hydrated with Taurine.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group A<br>15 sites received only scaling and root planing | Procedure: Scaling and root planing<br>* 15 sites with periodontal pockets ≥ 5mm received only SRP<br>* Other names: SRP;|
| Active Comparator: Group B<br>15 sites received scaling and root planing with subgingival placement of amnion membrane | Procedure: Scaling and root planing<br>* 15 sites with periodontal pockets ≥ 5mm received only SRP<br>* Other names: SRP;Biological: Amnion membrane<br>* 15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane.<br>* Other names: AM;|
| Active Comparator: Group C<br>15 sites received scaling and root planing with subgingival placement of amnion membrane hydrated with Taurine | Procedure: Scaling and root planing<br>* 15 sites with periodontal pockets ≥ 5mm received only SRP<br>* Other names: SRP;Biological: Amnion membrane<br>* 15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane.<br>* Other names: AM;Drug: Taurine<br>* 15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane hydrated with taurine.<br>* Other names: T;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF-α level | TNF-α level in Gingival crevicular fluid | changes from baseline to 45 days | 
| Probing pocket depth (PPD) | Probing pocket depth at selected site | changes from baseline to 45 days | 
| Relative attachment level (RAL) | Relative attachment level from stent to base of the pocket | changes from baseline to 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index (PI) | Plaque index (PI) - Silness and Loe 1964 site specific | changes from baseline to 45 days | 
| Gingival index (GI) | Gingival index (GI) - Loe and Silness 1963 site specific | changes from baseline to 45 days | 
| Bleeding on probing (BOP) | Bleeding on probing (BOP): Muhlemann HR & Son 1971 sit specific | changes from baseline to 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, taurine, amnion membrane