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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772508
• Other study ID #: 13/395
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: March 13, 2021

Study information

• Verified date: March 2021
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 13, 2021
• Est. primary completion date: March 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Scaling and root planing
15 sites with periodontal pockets = 5mm received only SRP

Biological:
• Amnion membrane
15 sites with periodontal pockets = 5mm received SRP along with placement of amnion membrane.

Drug:
• Taurine
15 sites with periodontal pockets = 5mm received SRP along with placement of amnion membrane hydrated with taurine.

Locations

Country	Name	City	State
India	Department of Periodontology, M.M. College of Dental Sciences and Research.	Ambala	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi Markendeswar University (Deemed to be University)

Country where clinical trial is conducted

India, 

References & Publications (2)

Giris M, Depboylu B, Dogru-Abbasoglu S, Erbil Y, Olgaç V, Alis H, Aykaç-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. — View Citation

Gültekin SE, Sengüven 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TNF-a level	TNF-a level in Gingival crevicular fluid	changes from baseline to 45 days
Primary	Probing pocket depth (PPD)	Probing pocket depth at selected site	changes from baseline to 45 days
Primary	Relative attachment level (RAL)	Relative attachment level from stent to base of the pocket	changes from baseline to 45 days
Secondary	Plaque index (PI)	Plaque index (PI) - Silness and Loe 1964 site specific	changes from baseline to 45 days
Secondary	Gingival index (GI)	Gingival index (GI) - Loe and Silness 1963 site specific	changes from baseline to 45 days
Secondary	Bleeding on probing (BOP)	Bleeding on probing (BOP): Muhlemann HR & Son 1971 sit specific	changes from baseline to 45 days