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

Not Applicable

Recruiting

• Conditions: Gingival Recession, Localized
• Interventions: Procedure: Coronally Advanced Flap combined with a Connective Tissue Graft; Procedure: Coronally Advanced Flap combined with a Meshed Connective Tissue Graft; Device: Meshing of Connective Tissue Graft

• Registration Number: NCT06030947
• Lead Sponsor: Göteborg University

Brief Summary

The objective of this project is to evaluate 1-year outcomes of treatment of MAGRD using a modified coronally advanced tunnel technique (MCAT) with either conventional CTG (control group) or micro-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 the presence of thin gingival tissues is one of the predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts (CTGs) during the surgical correction is often considered. CTGs are 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 GRDs, the preferred surgical approach should offer the greatest possible root coverage, while limiting drawbacks (i.e., patient morbidity, esthetic problems). Thus, one of the challenges related to coverage of multiple GRDs is the scarcity of donor tissue. In cases when large CTGs are required, additional surgical procedures may even be necessary. As an alternative, a modification of the harvested CTG into multiple "micro-CTGs" is proposed for the treatment of multiple adjacent GRDs (MAGRD). In the present study, the effectiveness and predictability of micro-CTGs will be evaluated in direct comparison to conventional CTGs.

The investigators hypothesise that no statistically significant differences will be observed in terms of % root coverage (primary outcome) and patient satisfaction at 12 months (non-inferiority).

The investigators hypothesise that subjects in the test group (micro-CTG) will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls (superiority).

Study Timeline

• Study First Submitted: 2023-09-03
• Study First Submitted QC: 2023-09-03
• Study First Posted: 2023-09-11
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-01-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

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

Inclusion Criteria

• age ≥18 years,
• systemically healthy,
• presenting with a minimum of 4 and a maximum of 6 adjacent RT1/RT2 recessions, located in the maxilla or mandible with an apico-coronal extension (i.e. recession depth) of ≥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.
• thick phenotype,
• severe tooth malpositioning,
• uncorrected trauma from toothbrushing,
• a previous history of root coverage procedures
• the presence of furcation defects.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Connective Tissue Graft	Coronally Advanced Flap combined with a 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.
Meshed Connective Tissue Graft	Coronally Advanced Flap combined with a 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.
Meshed Connective Tissue Graft	Meshing of 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.

Primary Outcome Measures

Name	Time	Method
Mean mid-facial recession coverage (mRC)	up to 1 year	Percentage of the exposed tooth root covered after surgical intervention

Secondary Outcome Measures

Name	Time	Method
Complete Root Coverage (CRC)	up to 1 year	Frequency of complete root coverage
Changes of Keratinized Tissue Width (KTW)	up to 1 year	Measured as the distance from the muco-gingival-junction to the gingival margin
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
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')
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')

Trial Locations

Locations (1)

Confident Dubai Palm; 🇦🇪 Dubai, United Arab Emirates