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Comparison of Two Flaps for Root Coverage

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CAF plus connective tissue graft
Tunnel plus connective tissue graft
Sodium dipyrone
chlorhexidine rinse
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    CAF plus connective tissue graft

    Tunnel plus connective tissue graft

    Arm 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 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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    June 23, 2016
    Last Updated
    April 30, 2020
    Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02814279
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CAF plus connective tissue graft
    Arm Type
    Active Comparator
    Arm 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 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.
    Arm Title
    Tunnel plus connective tissue graft
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    CAF plus connective tissue graft
    Other Intervention Name(s)
    Periodontal plastic surgery
    Intervention Description
    Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.
    Intervention Type
    Procedure
    Intervention Name(s)
    Tunnel plus connective tissue graft
    Other Intervention Name(s)
    Periodontal plastic surgery
    Intervention Description
    Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium dipyrone
    Other Intervention Name(s)
    Drug prescription
    Intervention Description
    All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
    Intervention Type
    Drug
    Intervention Name(s)
    chlorhexidine rinse
    Other Intervention Name(s)
    Drug prescription
    Intervention Description
    All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
    Primary Outcome Measure Information:
    Title
    Percentage of Defect Coverage
    Description
    Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Root Coverage Esthetic Score
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mauro P Santamaria, PhD
    Organizational Affiliation
    ICT-UNESP
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    17309597
    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.
    Results Reference
    background
    PubMed Identifier
    17990442
    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.
    Results Reference
    background
    PubMed Identifier
    7928129
    Citation
    Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.
    Results Reference
    background
    PubMed Identifier
    28231619
    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.
    Results Reference
    derived

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    Comparison of Two Flaps for Root Coverage

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