Clinical trial NCT06030947: Effectiveness of Micro Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects
Official title: Tunnel Surgery Combined With a Micro Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recession Defects: a Multi-center Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession, Localized
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Mean mid-facial recession coverage (mRC)
timeFrame: up to 1 year
Secondary outcomes:
measure: Complete Root Coverage (CRC)
timeFrame: up to 1 year
measure: Changes of Keratinized Tissue Width (KTW)
timeFrame: up to 1 year
measure: Changes of Gingival Thickness (GT)
timeFrame: up to 1 year
measure: Patient Morbidity
timeFrame: up to 2 weeks
measure: Patient Satisfaction
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: Confident Dubai Palm
Study officials:
affiliation: Goteborg University
name: Jan Derks, DDS, PhD
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.