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

NCT ID: NCT06650072

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-01

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).

Conditions

Gingival Recession, Localized

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Palatal Micro Connective Tissue Graft

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

The connective tissue graft will be harvested from the palate.

Tuberosity Micro Connective Tissue Graft

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

Interventions

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

The connective tissue graft will be harvested from the palate.

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Derks, DDS, PhD

Role: STUDY_CHAIR

Goteborg University

Central Contacts

Olivier Carcuac, DDS, PhD

Role: CONTACT

olivier.carcuac@gu.se

556275575 ext. 00971

Jan Derks, DDS, PhD

Role: CONTACT

jan.derks@odontologi.gu.se

317863124 ext. 0046

References

Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.

Reference Type: RESULT

PMID: 18584934 (View on PubMed)

Sanz-Martin I, Rojo E, Maldonado E, Stroppa G, Nart J, Sanz M. Structural and histological differences between connective tissue grafts harvested from the lateral palatal mucosa or from the tuberosity area. Clin Oral Investig. 2019 Feb;23(2):957-964. doi: 10.1007/s00784-018-2516-9. Epub 2018 Jun 18.

Reference Type: RESULT

PMID: 29915931 (View on PubMed)

Dellavia C, Ricci G, Pettinari L, Allievi C, Grizzi F, Gagliano N. Human palatal and tuberosity mucosa as donor sites for ridge augmentation. Int J Periodontics Restorative Dent. 2014 Mar-Apr;34(2):179-86. doi: 10.11607/prd.1929.

Reference Type: RESULT

PMID: 24600654 (View on PubMed)

Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.

Reference Type: RESULT

PMID: 19335093 (View on PubMed)

Other Identifiers

OCarcuac-tuberosity microCTG

Identifier Type: -

Identifier Source: org_study_id