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

Not Applicable

Not yet recruiting

• Conditions: Gingival Recession, Localized

• Registration Number: NCT06650072
• Lead Sponsor: Göteborg University

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-18
• Study First Posted: 2024-10-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Study Start: 2025-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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/Discomfort	up to 2 weeks	Measured using an oral health-related quality of life questionnaire (OHRQoL)
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')