Effectiveness of Meshed Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects

Sponsor
Göteborg University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06030947
Collaborator
(none)
30
2
19

Study Details

Study Description

Brief Summary

The objective of this project is to evaluate short-term and 1-year outcomes of treatment of multiple adjacent gingival recession defects (MAGRD) using the modified coronally advanced tunnel (MCAT) with either conventional CTG (control group) or meshed CTG (mesh-CTG) (test group).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Modified Coronally Advanced Tunnel combined with a Connective Tissue Graft
  • Procedure: Modified Coronally Advanced Tunnel combined with a Meshed Connective Tissue Graft
  • Device: Meshing of Connective Tissue Graft
N/A

Detailed Description

Gingival recession defects (GRD) present as a partial exposure of the root surface resulting from gingival margin displacement apical to the cemento-enamel junction (CEJ). A variety of surgical methods have been reported to reestablish root coverage, including tunneling techniques and coronally and laterally advanced flaps. As thin gingival tissue is one of the predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts (CTG) is often considered. CTG is thought to contribute to phenotype modification and stability of treatment outcomes and studies have indicated favorable esthetic results and high degrees of root coverage (documented range: 69% to 97%). The procedure does, however, require a suitable donor site. When multiple adjacent teeth exhibit GRD, the preferred surgical approach should offer the greatest root coverage while limiting drawback (i.e., patient morbidity, esthetic problems). Thus, one of the challenges related to root coverage is the scarcity of donor tissue. In cases when large CTGs are required, additional surgical procedures may even be necessary. As an alternative, modification of the harvested CTG into an expanded "mesh CTG" (mesh-CTG) has been proposed for the treatment of multiple adjacent GRDs (MAGRD). However, the effectiveness and predictability of mesh-CTG using the modified coronally advanced tunnel (MCAT) has not yet been evaluated in direct comparison to conventional CTG.

We hypothesise that no statistically significant differences will be observed in terms of %root coverage and patient satisfaction at 12 months. Subjects in the test group (mesh-CTG) will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Modified Tunnel Surgery Combined With a Meshed Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recession Defects : a Multi-center Controlled Randomized Clinical Trial.
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Connective Tissue Graft

A mucogingival surgery where a conventional connective tissue graft harvested from the palate is placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects.

Procedure: Modified Coronally Advanced Tunnel combined with a Connective Tissue Graft
Multiple adjacent gingival recession defects will be covered by modified coronally advanced tunnel combined with a connective tissue graft harvested from the palate.

Experimental: Meshed Connective Tissue Graft

A mucogingival surgery where a meshed connective tissue graft harvested from the palate is placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects.

Procedure: Modified Coronally Advanced Tunnel combined with a Meshed Connective Tissue Graft
Multiple adjacent gingival recession defects will be covered by modified coronally advanced tunnel combined with a meshed connective tissue graft harvested from the palate.

Device: Meshing of Connective Tissue Graft
The harvested connective tissue graft is meshed with a scalpel blade before being unfolded and placed on the recipient site.

Outcome Measures

Primary Outcome Measures

  1. Mean mid-facial recession coverage (mRC) [up to 1 year]

    Percentage of the exposed tooth root covered after surgical intervention

Secondary Outcome Measures

  1. Complete Root Coverage (CRC) [up to 1 year]

    Frequency of complete root coverage

  2. Changes of Keratinized Tissue Width (KTW) [up to 1 year]

    Measured as the distance from the muco-gingival-junction to the gingival margin

  3. Changes of Gingival Thickness (GT) [up to 1 year]

    Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth

  4. Patient Morbidity [up to 2 weeks]

    Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

  5. Patient Satisfaction [up to 1 year]

    Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('not satisfied') and 10 ('satisfied as much as it could possibly be')

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • age ≥18 years, systemically healthy, ≥3 adjacent RT1 recessions on both sides of the maxillary or mandibular arch with an apico-coronal extension (i.e. recession depth) >2 mm, Full-Mouth Plaque Score (FMPS) <20%, Full-Mouth Bleeding Score (FMBS) <20%.
Exclusion Criteria:
  • pregnancy or lactation, tobacco smoking, uncontrolled medical condition, medication that can affect gingival conditions.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Göteborg University

Investigators

  • Study Chair: Jan Derks, DDS, PhD, Goteborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Göteborg University
ClinicalTrials.gov Identifier:
NCT06030947
Other Study ID Numbers:
  • OCarcuac-meshCTG
First Posted:
Sep 11, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2023