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Comparison of Two Flaps for Root Coverage

Evaluation of Two Different Flaps Associated With Connective Tissue Graft in the Treatment of Gingival Recession: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02814279
Enrollment
42
Registered
2016-06-27
Start date
2014-02-28
Completion date
2015-10-31
Last updated
2020-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

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.

Interventions

PROCEDURECAF plus connective tissue graft

Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.

PROCEDURETunnel plus connective tissue graft

Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.

All participants were instructed to take 500 mg sodium dipyrone just in case of pain.

All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Defect Coverage6 monthsPercentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.

Secondary

MeasureTime frameDescription
Root Coverage Esthetic Score6 monthsThe 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.

Participant flow

Recruitment details

At clinical site

Pre-assignment details

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.

Participants by arm

ArmCount
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.
21
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.
21
Total42

Baseline characteristics

CharacteristicCAF Plus Connective Tissue GraftTunnel Plus Connective Tissue GraftTotal
Age, Continuous40.66 years
STANDARD_DEVIATION 8.89
39.71 years
STANDARD_DEVIATION 10.38
40.2 years
STANDARD_DEVIATION 9.6
Gingival recession depth3.2 millimeters
STANDARD_DEVIATION 0.7
3.0 millimeters
STANDARD_DEVIATION 0.6
3.0 millimeters
STANDARD_DEVIATION 0.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants0 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
19 Participants21 Participants40 Participants
Region of Enrollment
Brazil
21 participants21 participants42 participants
Sex: Female, Male
Female
12 Participants15 Participants27 Participants
Sex: Female, Male
Male
9 Participants6 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 210 / 21
serious
Total, serious adverse events
0 / 210 / 21

Outcome results

Primary

Percentage of Defect Coverage

Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
CAF Plus Connective Tissue GraftPercentage of Defect Coverage87.2 percentage of root coverageStandard Deviation 27.1
Tunnel Plus Connective Tissue GraftPercentage of Defect Coverage77.4 percentage of root coverageStandard Deviation 20.4
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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
CAF Plus Connective Tissue GraftRoot Coverage Esthetic Score8.12 units on a scaleStandard Deviation 1.55
Tunnel Plus Connective Tissue GraftRoot Coverage Esthetic Score7.98 units on a scaleStandard Deviation 1.74

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026