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NCT Number: NCT06650072

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

The connective tissue graft will be harvested from the palate.

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

Procedure

The connective tissue graft will be harvested from the maxillary tuberosity.

Primary outcomes

  1. Mean mid-facial recession coverage (mRC)

    Time frame: up to 1 year

    Percentage of the exposed tooth root covered after surgical intervention

Secondary outcomes

  1. Complete Root Coverage (CRC)

    Time frame: up to 1 year

    Frequency of complete root coverage

  2. Changes of Keratinized Tissue Width (KTW)

    Time frame: up to 1 year

    Measured as the distance from the muco-gingival-junction to the gingival margin

  3. Changes of Gingival Thickness (GT)

    Time frame: up to 1 year

    Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth

  4. Patient Morbidity/Discomfort

    Time frame: up to 2 weeks

    Measured using an oral health-related quality of life questionnaire (OHRQoL)

  5. Patient Satisfaction

    Time frame: 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')

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Derks, DDS, PhD

CONTACT

[email protected]

317863124 ext. 0046

Olivier Carcuac, DDS, PhD

CONTACT

[email protected]

556275575 ext. 00971

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

Palatal vs Tuberosity Micro-connective Tissue Grafts for the Treatment of Multiple Adjacent Gingival Recession Defects: a Multi-center Controlled Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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