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OpenTrials
Completed

NCT Number: NCT04772508

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

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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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

29 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology, M.M. College of Dental Sciences and Research.

Ambāla, Haryana, 133207, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Scaling and Root Planing

Procedure

15 sites with periodontal pockets ≥ 5mm received only SRP

Other names: SRP

Amnion membrane

Biological

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

Other names: AM

Taurine

Drug

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

Other names: T

Primary outcomes

  1. TNF-α level

    Time frame: changes from baseline to 45 days

    TNF-α level in Gingival crevicular fluid

  2. Probing pocket depth (PPD)

    Time frame: changes from baseline to 45 days

    Probing pocket depth at selected site

  3. Relative attachment level (RAL)

    Time frame: changes from baseline to 45 days

    Relative attachment level from stent to base of the pocket

Secondary outcomes

  1. Plaque index (PI)

    Time frame: changes from baseline to 45 days

    Plaque index (PI) - Silness and Loe 1964 site specific

  2. Gingival index (GI)

    Time frame: changes from baseline to 45 days

    Gingival index (GI) - Loe and Silness 1963 site specific

  3. Bleeding on probing (BOP)

    Time frame: changes from baseline to 45 days

    Bleeding on probing (BOP): Muhlemann HR & Son 1971 sit specific

Sponsors and collaborators

Lead sponsor

Maharishi Markendeswar University (Deemed to be University)

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2021
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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