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

NCT04772508 | Completed DMC

• 1 other identifier: 13/395
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

periodontitis; taurine; amnion membrane

Outcome Measures

Primary Outcomes (3)

• TNF-α level

  TNF-α level in Gingival crevicular fluid

  changes from baseline to 45 days

• Probing pocket depth (PPD)

  Probing pocket depth at selected site

  changes from baseline to 45 days

• Relative attachment level (RAL)

  Relative attachment level from stent to base of the pocket

  changes from baseline to 45 days

Secondary Outcomes (3)

• Plaque index (PI)

  changes from baseline to 45 days

• Gingival index (GI)

  changes from baseline to 45 days

• Bleeding on probing (BOP)

  changes from baseline to 45 days

Study Arms (3)

Group A

SHAM COMPARATOR

15 sites received only scaling and root planing

Procedure: Scaling and root planing

Group B

ACTIVE COMPARATOR

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

Procedure: Scaling and root planing; Biological: Amnion membrane

Group C

ACTIVE COMPARATOR

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

Procedure: Scaling and root planing; Biological: Amnion membrane; Drug: Taurine

Interventions

Scaling and root planing PROCEDURE

15 sites with periodontal pockets ≥ 5mm received only SRP

Also known as: SRP

Group A; Group B; Group C

Amnion membrane BIOLOGICAL

15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane.

Also known as: AM

Group B; Group C

Taurine DRUG

15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane hydrated with taurine.

Also known as: T

Group C

Eligibility Criteria

• Age: 29 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maharishi Markendeswar University (Deemed to be University): lead

Study Sites (1)

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

Ambāla, Haryana, 133207, India

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing; Taurine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• surinder sachdeva, M.D.S.

  PROFESSOR

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients and statistician are masked about treatment modality
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: 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 Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: December 1, 2020
• Primary Completion: March 13, 2021
• Study Completion: March 13, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)