Clinical trial NCT02814279: Comparison of Two Flaps for Root Coverage
Official title: Evaluation of Two Different Flaps Associated With Connective Tissue Graft in the Treatment of Gingival Recession: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare clinical, esthetic and patient-centered outcomes of coronally advanced tunnel (TUN) and coronally advanced flap (CAF) both associated with connective tissue graft (CTG) in the treatment of gingival recession.

Detailed description: This is a prospective, parallel and controlled clinical trial. The population evaluated in the study was selected at Institute of Science and Technology (ICT), São José dos Campos, College of Dentistry.

Patients were assigned to one of the three treatment groups:

* Group TUN+CTG (21): Periodontal surgery for root coverage through tunnel flap technique plus connective tissue graft.
* Group CAF+CTG (21): Periodontal surgery for root coverage through trapezoidal flap plus connective tissue graft.

All surgical procedures were performed by a single operator (MPS). The gingival recession defects were randomly treated by either the trapezoidal-type of coronally advanced flap plus connective tissue graft (CAF+CTG) or the coronally advanced tunnel technique with subepithelial connective tissue graft (TUN+CTG). In brief description, CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the cement-enamel junction (CEJ), followed by interrupted sutures to close the releasing incisions. The tunnel flap was performed with initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ. After the surgery, the participants were requested to take 500 mg of sodium dipyrone every 4 hours for 3 days in case of pain, and to avoid brushing and flossing in the treated area for a period of 2 weeks. During this period, plaque control was performed using 0.12% chlorhexidine rinse used twice a day. The sutures were removed after 7 days, and all of the patients were recalled for prophylaxis and reinforcement of motivation and instruction for atraumatic tooth brushing during the study period.

Clinical, esthetics, and comfort of patients parameters were assessed at 45 days, 2, 3 and 6 months after the procedure.

Quantitative data were recorded as mean ± standard deviation (SD), and normality was tested using Shapiro-Wilk tests. The probing depth (PD), relative gingival recession (RGR), clinical attachment level (CAL), keratinized tissue thickness (KTT), keratinized tissue width (KTW), and dentin hypersensitivity (DH) values were examined by two-way repeated measures ANOVA to evaluate the differences within and between groups, followed by a Tukey test for multiple comparisons when the Shapiro-Wilk p value was ≥ 0.05. Those presenting Shapiro-Wilk p values \< 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). Patients' esthetics and discomfort measures using visual analog scale (VAS) were analyzed by T-tests. The frequency of complete root coverage was compared using χ2 tests. Intergroup root coverage esthetic score (RES) comparisons were performed with a T-test. A significance level of 0.05 was adopted.

Eligibility criteria: Inclusion Criteria:

* Patients presenting Miller class I or II gingival recession in the maxillary canines or premolars
* Visible cemento-enamel junction (CEJ) with pulp vitality;
* Patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤20%;
* Patients older than 18 years old; probing depth ˂3 mm in the included teeth;
* Patients who agreed to participate and signed an informed consent form.

Exclusion Criteria:

* Patients presenting systemic problems that would contraindicate the surgical procedure;
* Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
* Smokers or pregnant women;
* Patients who underwent periodontal surgery in the area of interest;
* Patients with orthodontic therapy in progress.

Primary outcomes:
measure: Percentage of Defect Coverage
timeFrame: 6 months
Secondary outcomes:
measure: Root Coverage Esthetic Score
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: ICT-UNESP
name: Mauro P Santamaria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
citation: Zuhr O, Fickl S, Wachtel H, Bolz W, Hurzeler MB. Covering of gingival recessions with a modified microsurgical tunnel technique: case report. Int J Periodontics Restorative Dent. 2007 Oct;27(5):457-63.
citation: Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.
citation: Santamaria MP, Neves FLDS, Silveira CA, Mathias IF, Fernandes-Dias SB, Jardini MAN, Tatakis DN. Connective tissue graft and tunnel or trapezoidal flap for the treatment of single maxillary gingival recessions: a randomized clinical trial. J Clin Periodontol. 2017 May;44(5):540-547. doi: 10.1111/jcpe.12714. Epub 2017 Apr 12.