Treatment of Buccal Ginvigal Recessions With the Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. A Randomized Clinical Trial

• Sponsor: University of Lisbon (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05436002
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief Summary

To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.

Condition or Disease	Intervention/Treatment	Phase
Cross-linked Hyaluronic Acid	Device: With Cross-linked Hyaluronic Acid	N/A

Detailed Description

To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.

To evaluate the esthetic outcome as perceived by periodontists, using the root coverage esthetic score (RES).

Test Group - Tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.

Control Group - Tunnel technique and subepithelial palatal connective tissue grafts.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Buccal Ginvigal Recessions With the Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. A Randomized Clinical Trial
• Anticipated Study Start Date: Oct 15, 2022
• Anticipated Primary Completion Date: May 15, 2023
• Anticipated Study Completion Date: Oct 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: With Cross-linked Hyaluronic Acid Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft.	Device: With Cross-linked Hyaluronic Acid; Without Cross-linked Hyaluronic Acid
Placebo Comparator: Whitout Cross-linked Hyaluronic Acid Tunnel Technique in Conjunction With Subepithelial Connective Tissue Graft.	Device: With Cross-linked Hyaluronic Acid; Without Cross-linked Hyaluronic Acid

Outcome Measures

Primary Outcome Measures

1. Gingival margin [6 month after surgery]

   Score 0: failure of root coverage (gingival margin apical or equal to the baseline recession); Score 3: partial root coverage; Score 6: complete root coverage with no detectable CEJ.

2. Marginal tissue contour [6 month after surgery]

   Score 0: irregular gingival margin (it does not follow CEJ); Score 1: proper marginal contour/scalloped gingival margin (following CEJ).

3. Soft tissue texture [6 month after surgery]

   Score 0: presence of scar formation and/or keloid-like appearance; Score 1: absence of scar or keloid formation.

4. Mucogingival junction [6 month after surgery]

   Score 0: MGJ not aligned with MGJ on adjacent teeth; Score 1: MGJ aligned with MGJ on adjacent teeth.

5. Gingival color [6 month after surgery]

   Score 0: color of tissue differs from gingival color on adjacent teeth; Score 1: normal color and integration with the adjacent soft tissues.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• None of the patients were smokers and all were systemically healthy without any signs of periodontal disease.

• Each patient had to display at least one ginvigal recession (RT1) of a depth of ≥ 2 mm.

• Patients exhibited an adequate level of oral hygiene evidenced by a full- mouth plaque score (FMPS) < 25%39 and full-mouth bleeding score (FMBS) < 25%.

Exclusion Criteria:

• Smokers

• Gingival recesstion RT 2 or RT 3 (Cairo 2011).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Lisbon

Investigators

• Principal Investigator: Vanessa Rodrigues, Dr, University of Lisbon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vanessa Rocha Rodrigues, Dra, University of Lisbon
• ClinicalTrials.gov Identifier: NCT05436002
• Other Study ID Numbers: Cross-linked hyaluronic acid
• First Posted: Jun 28, 2022
• Last Update Posted: Jun 28, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vanessa Rocha Rodrigues, Dra, University of Lisbon: cross-linked hyaluronic acid; tunnel technique; gingival recession
• Additional relevant MeSH terms: Hyaluronic Acid

Study Results

No Results Posted as of Jun 28, 2022