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

Göteborg University

Status: Begins enrollment in 3 months

Conditions: Gingival Recession, Localized

Treatments: Procedure: modified coronally advanced tunnel technique combined with multiple palatal micro connective tissue grafts; Procedure: modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue grafts

Study type: Interventional

Funder types: Other

Identifiers

NCT06650072

OCarcuac-tuberosity microCTG

Details and patient eligibility

About

The objective of this project is to compare post-operative pain associated with palatal and tuberosity donor sites for micro-CTG, and to evaluate the outcomes in both the donor and recipient sites.

Full description

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 (CTGs) 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. CTGs are preferably harvested either from the lateral superficial part of the palate or from the tuberosity, due to the high amount of lamina propria and minimal submucosal tissue (adipose and glandular tissue).

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. Modification of the harvested CTG into multiple "micro-CTG" has been proposed for the treatment of multiple adjacent GRDs (MAGRD) in order to reduce the amount of CTG to be harvested. Soft-tissue grafts from the tuberosity are increasingly gaining popularity not only because they are easier to harvest, are denser in connective tissue fibers but also because harvesting from the tuberosity presents minimal risk of intra- or post-operative complications, resulting in reduced patient morbidity. However CTG from maxillary tuberosity have been reported to induce a hyperplastic response in some patients.

The objective of this study will be to compare palatal versus tuberosity micro-CTG on postoperative pain, oral health-related quality of life (OHRQoL), degree of root coverage and esthetic outcomes.

The investigators hypothesise that no statistically significant differences will be observed in terms of %root coverage and patient satisfaction at 12 months (non-inferiority). 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 adjacent RT1/RT2 recessions, on both sides of the anterior maxilla, with an apico-coronal extension (i.e. recession depth) > 2mm combined with thick phenotype and deep root concavity.

Exclusion criteria

• pregnancy or lactation,
• heavy tobacco smoking (>15 cigarettes/day),
• uncontrolled medical conditions and intake of medication that can affect gingival conditions.
• uncorrected trauma from toothbrushing,
• severe tooth malposition,
• history of root coverage procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Palatal Micro Connective Tissue Graft

Active Comparator group

Description:

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

Treatment:

Procedure: modified coronally advanced tunnel technique combined with multiple palatal micro connective tissue grafts

Tuberosity Micro Connective Tissue Graft

Experimental group

Description:

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

Treatment:

Procedure: modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue grafts