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

June 22, 2022 updated by: Vanessa Rocha Rodrigues, University of Lisbon
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival margin
Time Frame: 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.
6 month after surgery
Marginal tissue contour
Time Frame: 6 month after surgery
Score 0: irregular gingival margin (it does not follow CEJ); Score 1: proper marginal contour/scalloped gingival margin (following CEJ).
6 month after surgery
Soft tissue texture
Time Frame: 6 month after surgery
Score 0: presence of scar formation and/or keloid-like appearance; Score 1: absence of scar or keloid formation.
6 month after surgery
Mucogingival junction
Time Frame: 6 month after surgery
Score 0: MGJ not aligned with MGJ on adjacent teeth; Score 1: MGJ aligned with MGJ on adjacent teeth.
6 month after surgery
Gingival color
Time Frame: 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.
6 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lisbon

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2022

Primary Completion (Anticipated)

May 15, 2023

Study Completion (Anticipated)

October 15, 2024

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cross-linked hyaluronic acid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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