Gingival Recession, Localized
Conditions
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).
Interventions
PROCEDUREmodified coronally advanced tunnel technique combined with multiple palatal micro connective tissue grafts
The connective tissue graft will be harvested from the palate.
PROCEDUREmodified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue grafts
The connective tissue graft will be harvested from the maxillary tuberosity.
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 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.
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/Discomfort | up to 2 weeks | Measured using an oral health-related quality of life questionnaire (OHRQoL) |
| 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') |
Contacts
Primary ContactOlivier Carcuac, DDS, PhD
Backup ContactJan Derks, DDS, PhD
Outcome results
None listed