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

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Scaling and root planing
Amnion membrane
Taurine
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, taurine, amnion membrane

Eligibility Criteria

29 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

15 sites received only scaling and root planing

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

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

Outcomes

Primary Outcome Measures

TNF-α level
TNF-α level in Gingival crevicular fluid
Probing pocket depth (PPD)
Probing pocket depth at selected site
Relative attachment level (RAL)
Relative attachment level from stent to base of the pocket

Secondary Outcome Measures

Plaque index (PI)
Plaque index (PI) - Silness and Loe 1964 site specific
Gingival index (GI)
Gingival index (GI) - Loe and Silness 1963 site specific
Bleeding on probing (BOP)
Bleeding on probing (BOP): Muhlemann HR & Son 1971 sit specific

Full Information

First Posted
February 23, 2021
Last Updated
March 13, 2021
Sponsor
Maharishi Markendeswar University (Deemed to be University)
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1. Study Identification

Unique Protocol Identification Number
NCT04772508
Brief Title
Effect of Amnion Membrane With and Without Taurine on GCF TNF α Level.
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
March 13, 2021 (Actual)
Study Completion Date
March 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi Markendeswar University (Deemed to be University)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
periodontitis, taurine, amnion membrane

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
patients and statistician are masked about treatment modality
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Sham Comparator
Arm Description
15 sites received only scaling and root planing
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
15 sites received scaling and root planing with subgingival placement of amnion membrane
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
15 sites received scaling and root planing with subgingival placement of amnion membrane hydrated with Taurine
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Other Intervention Name(s)
SRP
Intervention Description
15 sites with periodontal pockets ≥ 5mm received only SRP
Intervention Type
Biological
Intervention Name(s)
Amnion membrane
Other Intervention Name(s)
AM
Intervention Description
15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane.
Intervention Type
Drug
Intervention Name(s)
Taurine
Other Intervention Name(s)
T
Intervention Description
15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane hydrated with taurine.
Primary Outcome Measure Information:
Title
TNF-α level
Description
TNF-α level in Gingival crevicular fluid
Time Frame
changes from baseline to 45 days
Title
Probing pocket depth (PPD)
Description
Probing pocket depth at selected site
Time Frame
changes from baseline to 45 days
Title
Relative attachment level (RAL)
Description
Relative attachment level from stent to base of the pocket
Time Frame
changes from baseline to 45 days
Secondary Outcome Measure Information:
Title
Plaque index (PI)
Description
Plaque index (PI) - Silness and Loe 1964 site specific
Time Frame
changes from baseline to 45 days
Title
Gingival index (GI)
Description
Gingival index (GI) - Loe and Silness 1963 site specific
Time Frame
changes from baseline to 45 days
Title
Bleeding on probing (BOP)
Description
Bleeding on probing (BOP): Muhlemann HR & Son 1971 sit specific
Time Frame
changes from baseline to 45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
surinder sachdeva, M.D.S.
Organizational Affiliation
PROFESSOR
Official's Role
Study Director
Facility Information:
Facility Name
Department of Periodontology, M.M. College of Dental Sciences and Research.
City
Ambala
State/Province
Haryana
ZIP/Postal Code
133207
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18241224
Citation
Giris M, Depboylu B, Dogru-Abbasoglu S, Erbil Y, Olgac V, Alis H, Aykac-Toker G, Uysal M. Effect of taurine on oxidative stress and apoptosis-related protein expression in trinitrobenzene sulphonic acid-induced colitis. Clin Exp Immunol. 2008 Apr;152(1):102-10. doi: 10.1111/j.1365-2249.2008.03599.x. Epub 2008 Jan 28.
Results Reference
background
PubMed Identifier
21574832
Citation
Gultekin SE, Senguven B, Sofuoglu A, Taner L, Koch M. Effect of the topical use of the antioxidant taurine on the two basement membrane proteins of regenerating oral gingival epithelium. J Periodontol. 2012 Jan;83(1):127-34. doi: 10.1902/jop.2011.100568. Epub 2011 May 16.
Results Reference
background

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

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