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

March 13, 2021 updated by: DR SURINDER SACHDEVA, Maharishi Markendeswar University (Deemed to be University)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Ambala, Haryana, India, 133207
        • Department of Periodontology, M.M. College of Dental Sciences and Research.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

29 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TNF-α level
Time Frame: changes from baseline to 45 days
TNF-α level in Gingival crevicular fluid
changes from baseline to 45 days
Probing pocket depth (PPD)
Time Frame: changes from baseline to 45 days
Probing pocket depth at selected site
changes from baseline to 45 days
Relative attachment level (RAL)
Time Frame: changes from baseline to 45 days
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)
Time Frame: changes from baseline to 45 days
Plaque index (PI) - Silness and Loe 1964 site specific
changes from baseline to 45 days
Gingival index (GI)
Time Frame: changes from baseline to 45 days
Gingival index (GI) - Loe and Silness 1963 site specific
changes from baseline to 45 days
Bleeding on probing (BOP)
Time Frame: changes from baseline to 45 days
Bleeding on probing (BOP): Muhlemann HR & Son 1971 sit specific
changes from baseline to 45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maharishi Markendeswar University (Deemed to be University)

Investigators

  • Study Director: surinder sachdeva, M.D.S., Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

March 13, 2021

Study Completion (Actual)

March 13, 2021

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 13, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/395

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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