Clinical trial NCT04772508: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: periodontitis
taurine
amnion membrane
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 45
Sex: ALL
Minimum age (years): 29
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: TNF-α level
timeFrame: changes from baseline to 45 days
measure: Probing pocket depth (PPD)
timeFrame: changes from baseline to 45 days
measure: Relative attachment level (RAL)
timeFrame: changes from baseline to 45 days
Secondary outcomes:
measure: Plaque index (PI)
timeFrame: changes from baseline to 45 days
measure: Gingival index (GI)
timeFrame: changes from baseline to 45 days
measure: Bleeding on probing (BOP)
timeFrame: changes from baseline to 45 days
Other outcomes:
Locations:
city: Ambala
country: India
facility: Department of Periodontology, M.M. College of Dental Sciences and Research.
state: Haryana
Study officials:
affiliation: PROFESSOR
name: surinder sachdeva, M.D.S.
role: STUDY_DIRECTOR
References:
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.
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.