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

Gingival Recession, Localized Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06030947
• Other study ID #: OCarcuac-meshCTG
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: February 2024
• Source: Göteborg University
• Contact: Olivier Carcuac, DDS, PhD
• Phone: 556275575
• Email: olivier.carcuac[@]gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Consensus report. Mucogingival therapy. Ann Periodontol. 1996 Nov;1(1):702-6. doi: 10.1902/annals.1996.1.1.702. No abstract available. — View Citation

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. — View Citation

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 Sup — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean mid-facial recession coverage (mRC)	Percentage of the exposed tooth root covered after surgical intervention	up to 1 year
Secondary	Complete Root Coverage (CRC)	Frequency of complete root coverage	up to 1 year
Secondary	Changes of Keratinized Tissue Width (KTW)	Measured as the distance from the muco-gingival-junction to the gingival margin	up to 1 year
Secondary	Changes of Gingival Thickness (GT)	Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth	up to 1 year
Secondary	Patient Morbidity	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')	up to 2 weeks
Secondary	Patient Satisfaction	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')	up to 1 year