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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-03-13

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.

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

patients and statistician are masked about treatment modality

Study Groups

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Group A

15 sites received only scaling and root planing

Group Type SHAM_COMPARATOR

Scaling and root planing

Intervention Type PROCEDURE

15 sites with periodontal pockets ≥ 5mm received only SRP

Group B

15 sites received scaling and root planing with subgingival placement of amnion membrane

Group Type ACTIVE_COMPARATOR

Scaling and root planing

Intervention Type PROCEDURE

15 sites with periodontal pockets ≥ 5mm received only SRP

Amnion membrane

Intervention Type BIOLOGICAL

15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane.

Group C

15 sites received scaling and root planing with subgingival placement of amnion membrane hydrated with Taurine

Group Type ACTIVE_COMPARATOR

Scaling and root planing

Intervention Type PROCEDURE

15 sites with periodontal pockets ≥ 5mm received only SRP

Amnion membrane

Intervention Type BIOLOGICAL

15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane.

Taurine

Intervention Type DRUG

15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane hydrated with taurine.

Interventions

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Scaling and root planing

15 sites with periodontal pockets ≥ 5mm received only SRP

Intervention Type PROCEDURE

Amnion membrane

15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane.

Intervention Type BIOLOGICAL

Taurine

15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane hydrated with taurine.

Intervention Type DRUG

Other Intervention Names

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SRP AM T

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).

Minimum Eligible Age

29 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No