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

• ClinicalTrials.gov Identifier: NCT06030947
• Recruitment Status: Not yet recruiting
• First Posted: September 11, 2023
• Last Update Posted: February 28, 2024
• Sponsor: Göteborg University
• Information provided by (Responsible Party): Göteborg University

Tracking Information

• First Submitted Date: September 3, 2023
• First Posted Date: September 11, 2023
• Last Update Posted Date: February 28, 2024
• Estimated Study Start Date: June 1, 2024
• Estimated Primary Completion Date: June 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 3, 2023)

Mean mid-facial recession coverage (mRC) [ Time Frame: up to 1 year ]

Percentage of the exposed tooth root covered after surgical intervention

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 9, 2023)

• Complete Root Coverage (CRC) [ Time Frame: up to 1 year ]
  Frequency of complete root coverage
• Changes of Keratinized Tissue Width (KTW) [ Time Frame: up to 1 year ]
  Measured as the distance from the muco-gingival-junction to the gingival margin
• Changes of Gingival Thickness (GT) [ Time Frame: up to 1 year ]
  Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth
• Patient Morbidity [ Time Frame: 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')
• Patient Satisfaction [ Time Frame: 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')

Original Secondary Outcome Measures (submitted: September 3, 2023)

• Complete Root Coverage (CRC) [ Time Frame: up to 1 year ]
  Frequency of complete root coverage
• Changes of Keratinized Tissue Width (KTW) [ Time Frame: up to 1 year ]
  Measured as the distance from the muco-gingival-junction to the gingival margin
• Changes of Gingival Thickness (GT) [ Time Frame: up to 1 year ]
  Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth
• Patient Morbidity [ Time Frame: up to 2 weeks ]
  Measured with Visual Analogue Scale (VAS)
• Patient Satisfaction [ Time Frame: up to 1 year ]
  Measured with Visual Analogue Scale (VAS)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of Meshed Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects
• Official Title: Coronally Advanced Flap Combined With a Meshed Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recession Defects : a Multi-center Controlled Randomized Clinical Trial.
• 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 coronally advanced flap (CAF) with either conventional CTG (control group) or meshed CTG (mesh-CTG) (test group).

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 coronally advanced flap (CAF) 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Gingival Recession, Localized

Intervention

• Procedure: Coronally Advanced Flap combined with a Connective Tissue Graft
  Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a connective tissue graft harvested from the palate.
• Procedure: Coronally Advanced Flap combined with a Meshed Connective Tissue Graft
  Multiple adjacent gingival recession defects will be covered by coronally advanced flap 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.

Study Arms

• 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.
  Intervention: Procedure: Coronally Advanced Flap combined with a Connective Tissue Graft
• 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.
  Interventions:

  • Procedure: Coronally Advanced Flap combined with a Meshed Connective Tissue Graft
  • Device: Meshing of Connective Tissue Graft

Publications *

• Consensus report. Mucogingival therapy. Ann Periodontol. 1996 Nov;1(1):702-6. doi: 10.1902/annals.1996.1.1.702. No abstract available.
• Cairo F. Periodontal plastic surgery of gingival recessions at single and multiple teeth. Periodontol 2000. 2017 Oct;75(1):296-316. doi: 10.1111/prd.12186.
• Tonetti MS, Jepsen S; Working Group 2 of the European Workshop on Periodontology. Clinical efficacy of periodontal plastic surgery procedures: consensus report of Group 2 of the 10th European Workshop on Periodontology. J Clin Periodontol. 2014 Apr;41 Suppl 15:S36-43. doi: 10.1111/jcpe.12219.
• Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.
• Graziani F, Gennai S, Roldan S, Discepoli N, Buti J, Madianos P, Herrera D. Efficacy of periodontal plastic procedures in the treatment of multiple gingival recessions. J Clin Periodontol. 2014 Apr;41 Suppl 15:S63-76. doi: 10.1111/jcpe.12172.
• Cetiner D, Bodur A, Uraz A. Expanded mesh connective tissue graft for the treatment of multiple gingival recessions. J Periodontol. 2004 Aug;75(8):1167-72. doi: 10.1902/jop.2004.75.8.1167.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 3, 2023): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 1, 2025
• Estimated Primary Completion Date: June 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Olivier Carcuac, DDS, PhD; 556275575 ext 00971; olivier.carcuac@gu.se

Contact: Jan Derks, DDS, PhD; 317863124 ext 0046; jan.derks@odontologi.gu.se

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06030947
• Other Study ID Numbers: OCarcuac-meshCTG
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Göteborg University
• Original Responsible Party: Same as current
• Current Study Sponsor: Göteborg University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Göteborg University
• Verification Date: February 2024