Gingival Recession, Localized
Conditions
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).
Interventions
PROCEDURECoronally 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.
PROCEDURECoronally 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.
DEVICEDivision 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.
Sponsors
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean mid-facial recession coverage (mRC) | up to 1 year | Percentage of the exposed tooth root covered after surgical intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Root Coverage (CRC) | up to 1 year | Frequency of complete root coverage |
| Changes of Keratinized Tissue Width (KTW) | up to 1 year | Measured as the distance from the muco-gingival-junction to the gingival margin |
| Changes of Gingival Thickness (GT) | up to 1 year | Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth |
| Patient Morbidity | up to 2 weeks | Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be') |
| Patient Satisfaction | 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') |
Countries
United Arab Emirates
Contacts
Primary ContactOlivier Carcuac, DDS, PhD
Backup ContactJan Derks, DDS, PhD
Outcome results
None listed