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

NCT04772508 — Not applicable, Completed, 45 participants, Maharishi Markendeswar University (Deemed to be University)

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

Registry	NCT04772508
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	45 (Actual)
Sponsor	Maharishi Markendeswar University (Deemed to be University) (Other)
Conditions	Periodontitis
Interventions	Scaling and root planing, Amnion membrane, Taurine (Procedure, biological, drug)
Dates	start 2020-12-01, primary completion 2021-03-13, completion 2021-03-13, first posted 2021-02-26, last updated 2021-03-16
Locations	1 site in India

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Group A	Sham comparator	Procedure: Scaling and root planing	15 sites received only scaling and root planing
Group B	Active comparator	Procedure: Scaling and root planing; Biological: Amnion membrane	15 sites received scaling and root planing with subgingival placement of amnion membrane
Group C	Active comparator	Procedure: Scaling and root planing; Biological: Amnion membrane; Drug: Taurine	15 sites received scaling and root planing with subgingival placement of amnion membrane hydrated with Taurine

Scaling and root planing (Procedure), also known as SRP: 15 sites with periodontal pockets ≥ 5mm received only SRP
Amnion membrane (Biological), also known as AM: 15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane.
Taurine (Drug), also known as T: 15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane hydrated with taurine.

+Outcome measures

Primary outcomes

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 outcomes

Plaque index (PI) [changes from baseline to 45 days]: Plaque index (PI) - Silness and Loe 1964 site specific
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

+Eligibility

Sex: All, ages: 29 Years to 60 Years

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).

+Locations (1)

Facility	City	Country	Status
Department of Periodontology, M.M. College of Dental Sciences and Research.	Ambāla, Haryana	India

+Publications

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. PMID 18241224
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. PMID 21574832

+Investigators

surinder sachdeva, M.D.S., Study director, PROFESSOR