Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAF plus connective tissue graft | Active Comparator | 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 according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. |
|
| Tunnel plus connective tissue graft | Experimental | The tunnel flap was performed according to Zuhr et al., 2007. Following 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAF plus connective tissue graft | Procedure | Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Defect Coverage | Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Root Coverage Esthetic Score | The Root Coverage Esthetic Scale (RES; Cairo et al. 2009) was performed by two blinded and independent examiners (CFA and IFM) at the 6-month post-operative assessment. This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Because complete root coverage was the primary treatment goal, and the other variables were considered secondary, the value assigned for root coverage was 60% of the total score, whereas 40% was assigned to the other four variables. With regard to the assessment of the final position of the gingival margin, 3 points were given for partial root coverage, and 6 points were given for complete root coverage; 0 points were assigned when the final position of the gingival margin was equal or apical to the previous recession. One point was assigned for each of the other four variables. Thus, 10 points was a perfect score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mauro P Santamaria, PhD | ICT-UNESP | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17309597 | Background | 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. | |
| 17990442 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study recruited 45 eligible patients. However, three patients were excluded before assignment to groups. Two recruited patients never presented for treatment and one declined to proceed.
At clinical site
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CAF Plus Connective Tissue Graft | 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 according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft. Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain. chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures. |
| FG001 | Tunnel Plus Connective Tissue Graft | The tunnel flap was performed according to Zuhr et al., 2007. Following 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. Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft. Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain. chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CAF Plus Connective Tissue Graft | 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 according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft. Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain. chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Defect Coverage | Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe. | Posted | Mean | Standard Deviation | percentage of root coverage | 6 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAF Plus Connective Tissue Graft | 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 according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft. Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain. chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mauro P. Santamaria | Institute of Science and Technology of São José dos Campos (Unesp) | +55 (16) 981937777 | mauro.santamaria@ict.unesp.br |
Not provided
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011307 | Drug Prescriptions |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D055656 | Prescriptions |
| D010593 | Pharmaceutical Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tunnel plus connective tissue graft | Procedure | Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft. |
|
|
| Sodium dipyrone | Drug | All participants were instructed to take 500 mg sodium dipyrone just in case of pain. |
|
|
| chlorhexidine rinse | Drug | All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures. |
|
|
| 6 months |
| 7928129 | Background | Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37. |
| 28231619 | Derived | 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. |
| BG001 | Tunnel Plus Connective Tissue Graft | The tunnel flap was performed according to Zuhr et al., 2007. Following 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. Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft. Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain. chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gingival recession depth | Mean | Standard Deviation | millimeters |
|
| OG001 | Tunnel Plus Connective Tissue Graft | The tunnel flap was performed according to Zuhr et al., 2007. Following 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. Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft. Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain. chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures. |
|
|
| Secondary | Root Coverage Esthetic Score | The Root Coverage Esthetic Scale (RES; Cairo et al. 2009) was performed by two blinded and independent examiners (CFA and IFM) at the 6-month post-operative assessment. This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Because complete root coverage was the primary treatment goal, and the other variables were considered secondary, the value assigned for root coverage was 60% of the total score, whereas 40% was assigned to the other four variables. With regard to the assessment of the final position of the gingival margin, 3 points were given for partial root coverage, and 6 points were given for complete root coverage; 0 points were assigned when the final position of the gingival margin was equal or apical to the previous recession. One point was assigned for each of the other four variables. Thus, 10 points was a perfect score. | Posted | Mean | Standard Deviation | units on a scale | 6 months | photographs | photographs |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Tunnel Plus Connective Tissue Graft | The tunnel flap was performed according to Zuhr et al., 2007. Following 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. Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft. Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain. chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures. | 0 | 21 | 0 | 21 |
Not provided
Not provided
| D055093 |
| Periodontal Atrophy |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |