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Clinical Trials/CTRI/2025/06/089046
CTRI/2025/06/089046Not yet recruitingPhase 3

Evaluation Of Tunneling Technique With Amniotic Membrane Titanium-Platlet Rich Fibrin For Recession Coverage A Soft Tissue Cone Beam Computed Tomography Analysis

Institute Of Dental Sciences Bareilly1 site in 1 country24 target enrollmentStarted: July 18, 2025Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
To evaluate clinical efficiency of amniotic membrane for recession coverage using tunnel technique.

Study Overview

Brief Summary

Gingival recession GR  is the apical displacement of the gingival margin  exposing the tooth root and potentially causing sensitivity  aesthetic issues  and root caries. While traditional treatments like connective tissue grafts CTG are effective they involve donor site morbidity. The Vestibular Incision Subperiosteal Tunnel Access  VISTA  technique  a minimally invasive method  allows for efficient root coverage with fewer complications.

This study aims to compare the clinical effectiveness of two biomaterials Amniotic Membrane  AM  and Titanium Platelet Rich Fibrin  T PRF used in conjunction with the VISTA technique in treating Millers Class I gingival recession. The comparison focuses on parameters like gingival thickness keratinized tissue width  recession height  and mean root coverage.

A total of 24 sites will be randomly assigned to two groups  12 AM  12 T PRF. Pre  and post operative measurements, including soft tissue CBCT for gingival thickness  will be recorded and analyzed statistically.

The study is designed to determine which biomaterial offers better clinical outcomes and tissue regeneration potential, contributing to more effective, minimally invasive treatment strategies for gingival recession.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients above the age of 18yrs with one or more adjacent Type I recession site Miller Class I Individuals who will be systemically healthy with good oral hygiene practices.
  • •A visible cementoenamel junction CEJ and having a probing depth PD less than or equal to 4mm.

Exclusion Criteria

  • •They will have nonvital teeth at or adjacent to the recession site.
  • •Presence of cervical defects Pregnant or lactating women Those who had received any periodontal surgery or regenerative treatments in the last 6 months Restorations in adjacent teeth that could interfere with surgical success.
  • •Patients who are current smokers or with smoking history Patients with active periodontal disease Individuals on any medications that might disrupt periodontal tissue condition or healing process.

Outcomes

Primary Outcomes

To evaluate clinical efficiency of amniotic membrane for recession coverage using tunnel technique.

Time Frame: To evaluate clinical efficiency of amniotic membrane for recession coverage using tunnel technique. | To evaluate clinical efficiency of T-PRF for recession coverage using tunnel technique. | To compare the clinical results of using amniotic membrane versus T-PRF along with tunnel technique in the treatment of gingival recession defects. | To evaluate and compare the gingival tissue thickness before and after recession coverage using soft tissue CBCT technique.

To evaluate clinical efficiency of T-PRF for recession coverage using tunnel technique.

Time Frame: To evaluate clinical efficiency of amniotic membrane for recession coverage using tunnel technique. | To evaluate clinical efficiency of T-PRF for recession coverage using tunnel technique. | To compare the clinical results of using amniotic membrane versus T-PRF along with tunnel technique in the treatment of gingival recession defects. | To evaluate and compare the gingival tissue thickness before and after recession coverage using soft tissue CBCT technique.

To compare the clinical results of using amniotic membrane versus T-PRF along with tunnel technique in the treatment of gingival recession defects.

Time Frame: To evaluate clinical efficiency of amniotic membrane for recession coverage using tunnel technique. | To evaluate clinical efficiency of T-PRF for recession coverage using tunnel technique. | To compare the clinical results of using amniotic membrane versus T-PRF along with tunnel technique in the treatment of gingival recession defects. | To evaluate and compare the gingival tissue thickness before and after recession coverage using soft tissue CBCT technique.

To evaluate and compare the gingival tissue thickness before and after recession coverage using soft tissue CBCT technique.

Time Frame: To evaluate clinical efficiency of amniotic membrane for recession coverage using tunnel technique. | To evaluate clinical efficiency of T-PRF for recession coverage using tunnel technique. | To compare the clinical results of using amniotic membrane versus T-PRF along with tunnel technique in the treatment of gingival recession defects. | To evaluate and compare the gingival tissue thickness before and after recession coverage using soft tissue CBCT technique.

Secondary Outcomes

  • •To evaluate clinical efficiency of amniotic membrane for recession coverage using tunnel technique.(baseline(preoperatively) and at 6 months after the procedure.)

Investigators

Sponsor
Institute Of Dental Sciences Bareilly
Sponsor Class
Other [Institute of dental sciences Bareilly]

Study Sites (1)

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