Comparing Collagen and Natural Membrane to Treat Receding Gums Using a Gentle, Stitch-Free Technique

Comparative evaluation of the efficacy of collagen and amniotic in a non invasive approach to root coverage using pinhole surgical technique - a randomised controlled clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090574

Enrollment

Registered

2025-07-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Health Condition 1: K055- Other periodontal diseases

Interventions

Intervention1: Amniotic membrane: amniotic membrane is a periodontal tissue regenerative material with scaffold properties . it has anti-inflammatory and antimicrobial properties required for tissue r

Eligibility

Inclusion criteria

Inclusion criteria: Patient in the age group of 18 to 60 years. Miller Class I or II gingival recessions affecting the canines, vital anterior teeth, or premolars. The cementoenamel junction (CEJ) must be clearly identifiable, and the gingival thickness in the area of the recession must be at least 1 mm. The individual must exhibit good periodontal health, with no evidence of active periodontal disease or inflammation. Participants also agreed to participate and signed an informed consent form.

Exclusion criteria

Exclusion criteria: Patients who failed to maintain proper oral hygiene plaque index is greater than 1 after phase 1 therapy. Pregnant or lactating females. Individuals with fully restored teeth, dental mobility, cervical abrasion, caries, or abfraction. Those with a history of prolonged antibiotic use. Smokers and individuals who engage in Tobacco chewing.

Design outcomes

Primary

Measure	Time frame
Both materials are expected to aid wound healing. The amniotic membrane may improve comfort (VAS) and regeneration (CAL). Key clinical measures include: Recession Depth (RD), Recession Width (RW), Keratinized Tissue Width (KTW), Gingival Thickness (GT), Root Coverage (RC) %, Gingival Index (GI), Plaque Index (PI), and Probing Pocket Depth (PPD). If effective, it could be a cost-efficient option for gingival recession treatment. Timepoint: follow up at baseline, 3 months and 6 months	—

Measure

Time frame

Both materials are expected to aid wound healing. The amniotic membrane may improve comfort (VAS) and regeneration (CAL). Key clinical measures include: Recession Depth (RD), Recession Width (RW), Keratinized Tissue Width (KTW), Gingival Thickness (GT), Root Coverage (RC) %, Gingival Index (GI), Plaque Index (PI), and Probing Pocket Depth (PPD). If effective, it could be a cost-efficient option for gingival recession treatment. Timepoint: follow up at baseline, 3 months and 6 months

—

Secondary

Measure	Time frame
Changes in Gingival Index (GI), Plaque Index (PI), and Probing Pocket Depth (PPD) to assess gingival health, oral hygiene status, and periodontal stability throughout the study period. Timepoint: follow up at baseline, 3 months and 6 months	—

Countries

India

Contacts

Public ContactTanvika Mall

Santosh Demeed to be University

drshivani.sharma@santosh.ac.in9971794472

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026