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

Göteborg University

Status: Enrolling

Conditions: Gingival Recession, Localized

Treatments: Procedure: Coronally Advanced Flap combined with micro Connective Tissue Graft; Device: Division of the Connective Tissue Graft into multiple micro Connective Tissue Grafts; Procedure: Coronally Advanced Flap combined with a Connective Tissue Graft

Study type: Interventional

Funder types: Other

Identifiers

NCT06030947

OCarcuac-microCTG

Details and patient eligibility

About

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).

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Connective Tissue Graft

Active Comparator group

Description:

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.

Treatment:

Procedure: Coronally Advanced Flap combined with a Connective Tissue Graft

Micro Connective Tissue Graft

Experimental group

Description:

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

Treatment:

Device: Division of the Connective Tissue Graft into multiple micro Connective Tissue Grafts

Procedure: Coronally Advanced Flap combined with micro Connective Tissue Graft