Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04772508
Enrollment
45
Registered
2021-02-26
Start date
2020-12-01
Completion date
2021-03-13
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

periodontitis, taurine, amnion membrane

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.

Interventions

PROCEDUREScaling and root planing

15 sites with periodontal pockets ≥ 5mm received only SRP

BIOLOGICALAmnion membrane

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

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

Sponsors

Maharishi Markendeswar University (Deemed to be University)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

patients and statistician are masked about treatment modality

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.

Eligibility

Sex/Gender
ALL
Age
29 Years to 60 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
TNF-α levelchanges from baseline to 45 daysTNF-α level in Gingival crevicular fluid
Probing pocket depth (PPD)changes from baseline to 45 daysProbing pocket depth at selected site
Relative attachment level (RAL)changes from baseline to 45 daysRelative attachment level from stent to base of the pocket

Secondary

MeasureTime frameDescription
Plaque index (PI)changes from baseline to 45 daysPlaque index (PI) - Silness and Loe 1964 site specific
Gingival index (GI)changes from baseline to 45 daysGingival index (GI) - Loe and Silness 1963 site specific
Bleeding on probing (BOP)changes from baseline to 45 daysBleeding on probing (BOP): Muhlemann HR & Son 1971 sit specific

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026