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

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Procedure: Scaling and root planing; Biological: Amnion membrane; Drug: Taurine

• Registration Number: NCT04772508
• Lead Sponsor: Maharishi Markendeswar University (Deemed to be University)

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-26
• Status Verified: 2021-03
• Primary Completion: 2021-03-13
• Study Completion: 2021-03-13
• Last Update Submitted: 2021-03-13
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Amnion membrane	15 sites received scaling and root planing with subgingival placement of amnion membrane
Group B	Scaling and root planing	15 sites received scaling and root planing with subgingival placement of amnion membrane
Group C	Amnion membrane	15 sites received scaling and root planing with subgingival placement of amnion membrane hydrated with Taurine
Group A	Scaling and root planing	15 sites received only scaling and root planing
Group C	Scaling and root planing	15 sites received scaling and root planing with subgingival placement of amnion membrane hydrated with Taurine
Group C	Taurine	15 sites received scaling and root planing with subgingival placement of amnion membrane hydrated with Taurine

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Periodontology, M.M. College of Dental Sciences and Research.; 🇮🇳 Ambala, Haryana, India