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

Not Applicable

Not yet recruiting

• Conditions: Cross-linked Hyaluronic Acid
• Interventions: Device: With Cross-linked Hyaluronic Acid

• Registration Number: NCT05436002
• Lead Sponsor: University of Lisbon

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.

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 Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-22
• Last Update Submitted: 2022-06-22
• Study First Posted: 2022-06-28
• Last Update Posted: 2022-06-28
• Study Start: 2022-10-15
• Primary Completion: 2023-05-15
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With Cross-linked Hyaluronic Acid	With Cross-linked Hyaluronic Acid	Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft.
Whitout Cross-linked Hyaluronic Acid	With Cross-linked Hyaluronic Acid	Tunnel Technique in Conjunction With Subepithelial Connective Tissue Graft.

Primary Outcome Measures

Name	Time	Method
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).
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.
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.
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.
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.