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

NCT ID: NCT06030947

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-08-01

Brief Summary

The objective of this project is to evaluate 1-year outcomes of treatment of MAGRD using a modified coronally advanced tunnel technique (MCAT) with either conventional CTG (control group) or micro-CTG (test group).

Detailed Description

Gingival recession defects (GRD) present as a partial exposure of the root surface resulting from gingival margin displacement apical to the cemento-enamel junction (CEJ). A variety of surgical methods have been reported to reestablish root coverage, including tunneling techniques and coronally and laterally advanced flaps. As the presence of thin gingival tissues is one of the predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts (CTGs) during the surgical correction 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 (documented range: 69% to 97%). The procedure does, however, require a suitable donor site. 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. In cases when large CTGs are required, additional surgical procedures may even be necessary. As an alternative, a modification of the harvested CTG into multiple "micro-CTGs" is proposed for the treatment of multiple adjacent GRDs (MAGRD). In the present study, the effectiveness and predictability of micro-CTGs will be evaluated in direct comparison to conventional CTGs.

The investigators hypothesise that no statistically significant differences will be observed in terms of % root coverage (primary outcome) and patient satisfaction at 12 months (non-inferiority).

The investigators hypothesise that 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

Connective Tissue Graft

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

Group Type: ACTIVE_COMPARATOR

Coronally Advanced Flap combined with a Connective Tissue Graft

Intervention Type: PROCEDURE

Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a connective tissue graft harvested from the palate.

Micro Connective Tissue Graft

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

Group Type: EXPERIMENTAL

Coronally Advanced Flap combined with micro Connective Tissue Graft

Intervention Type: PROCEDURE

Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with multiple micro connective tissue graft harvested from the palate.

Division of the Connective Tissue Graft into multiple micro Connective Tissue Grafts

Intervention Type: DEVICE

The harvested connective tissue graft is divided in multiple micro connective tissue grafts with a scalpel blade before being placed on the recipient site.

Interventions

Coronally Advanced Flap combined with a Connective Tissue Graft

Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a connective tissue graft harvested from the palate.

Intervention Type: PROCEDURE

Coronally Advanced Flap combined with micro Connective Tissue Graft

Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with multiple micro connective tissue graft harvested from the palate.

Intervention Type: PROCEDURE

Division of the Connective Tissue Graft into multiple micro Connective Tissue Grafts

The harvested connective tissue graft is divided in multiple micro connective tissue grafts with a scalpel blade before being placed on the recipient site.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age ≥18 years,
• systemically healthy,
• presenting with a minimum of 4 and a maximum of 6 adjacent RT1/RT2 recessions, located in the maxilla or mandible with an apico-coronal extension (i.e. recession depth) of ≥2 mm,
• Full-Mouth Plaque Score (FMPS) <20%,
• Full-Mouth Bleeding Score (FMBS) <20%.

Exclusion Criteria

• pregnancy or lactation,
• tobacco smoking,
• uncontrolled medical condition,
• medication that can affect gingival conditions.
• thick phenotype,
• severe tooth malpositioning,
• uncorrected trauma from toothbrushing,
• a previous history of root coverage procedures
• the presence of furcation defects.

• 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

Locations

Confident Dubai Palm

Dubai, , United Arab Emirates

Site Status: RECRUITING

Countries

United Arab Emirates

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

Facility Contacts

Olivier Carcuac, PhD

Role: primary

olivier@carcuac.com

0556275575 ext. 00971

References

Consensus report. Mucogingival therapy. Ann Periodontol. 1996 Nov;1(1):702-6. doi: 10.1902/annals.1996.1.1.702. No abstract available.

Reference Type: RESULT

PMID: 9118277 (View on PubMed)

Cairo F. Periodontal plastic surgery of gingival recessions at single and multiple teeth. Periodontol 2000. 2017 Oct;75(1):296-316. doi: 10.1111/prd.12186.

Reference Type: RESULT

PMID: 28758301 (View on PubMed)

Tonetti MS, Jepsen S; Working Group 2 of the European Workshop on Periodontology. Clinical efficacy of periodontal plastic surgery procedures: consensus report of Group 2 of the 10th European Workshop on Periodontology. J Clin Periodontol. 2014 Apr;41 Suppl 15:S36-43. doi: 10.1111/jcpe.12219.

Reference Type: RESULT

PMID: 24640999 (View on PubMed)

Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.

Reference Type: RESULT

PMID: 24641000 (View on PubMed)

Graziani F, Gennai S, Roldan S, Discepoli N, Buti J, Madianos P, Herrera D. Efficacy of periodontal plastic procedures in the treatment of multiple gingival recessions. J Clin Periodontol. 2014 Apr;41 Suppl 15:S63-76. doi: 10.1111/jcpe.12172.

Reference Type: RESULT

PMID: 24641002 (View on PubMed)

Ronco V, Dard M. A novel suturing approach for tissue displacement within minimally invasive periodontal plastic surgery. Clin Case Rep. 2016 Jul 23;4(8):831-7. doi: 10.1002/ccr3.582. eCollection 2016 Aug.

Reference Type: RESULT

PMID: 27525096 (View on PubMed)

Other Identifiers

OCarcuac-microCTG

Identifier Type: -

Identifier Source: org_study_id