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NCT06650072 | NOT YET RECRUITING | Gingival Recession, Localized


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

Gothenburg 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.

Condition or disease

Gingival Recession, Localized

Intervention/treatment

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

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

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : Palatal vs Tuberosity Micro-connective Tissue Grafts for the Treatment of Multiple Adjacent Gingival Recession Defects: a Multi-center Controlled Randomized Clinical Trial
Actual Study Start Date : 2025-09-01
Estimated Primary Completion Date : 2026-09-01
Estimated Study Completion Date : 2026-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.

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

Location Details

NCT06650072


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