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Composite Resin Plus Connective Tissue Graft.

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Connective tissue graft
Composite resin restoration (Filtek Supreme - 3M)
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:

  • presenting Miller class I or II gingival recession in the maxillary canines or premolars associated with non-carious cervical lesion;
  • teeth included in the study should present 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 with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will 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; and

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Connective tissue graft (CTG)

    Connective tissue graft plus composite resin restoration.

    Arm Description

    After local anesthesia, the surgical procedure performed was the trapezoidal-type of CAF (de Sanctis & Zucchelli, 2007). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.

    After local anesthesia, the surgical procedure performed was the trapezoidal-type of CAF (de Sanctis & Zucchelli, 2007). After the flap was raised, a sterile rubber dam was placed to isolate the operative field and the non-carious cervical lesion restoration was performed with a nanocomposite resin (Filtek Supreme - 3M ESPE - St. Paul, MN, USA), following the manufacturer's instructions. Afterward, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.

    Outcomes

    Primary Outcome Measures

    Percentage of defect coverage

    Secondary Outcome Measures

    Root coverage esthetic score

    Full Information

    First Posted
    April 3, 2015
    Last Updated
    April 22, 2015
    Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02423473
    Brief Title
    Composite Resin Plus Connective Tissue Graft.
    Official Title
    Composite Resin Plus Connective Tissue Graft to Treat Gingival Recession Associated With Non-carious Cervical Lesion. Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    February 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 the present study is to evaluate the clinical, aesthetic and patient-centered parameters of connective tissue graft associated or not with composite resin for the treatment of gingival recession.
    Detailed Description
    This was a prospective, parallel and controlled clinical trial. Group CTG (n = 18) - patients who received connective tissue graft to treat gingival recession associated with non-carious cervical lesion. Group CTG+RC (n = 18) - patients who received connective tissue graft plus resin composite restoration to treat gingival recession associated with non-carious cervical lesion. The surgeries, as well as all postoperative follow-up, were performed at the dental clinic of ICT- UNESP. Two horizontal incisions were made at right angles to the adjacent interdental papillae, without interfering with the gingival margins of neighboring teeth. Two oblique vertical incisions were extended beyond the mucogingival junction, and a trapezoidal mucoperiosteal flap was raised up to the mucogingival junction. After this point, a split-thickness flap was extended apically, releasing the tension and favoring coronal positioning of the flap.The exposed root surface was gently scaled and planed until it became smooth in the CTG group. For those allocated to CTG+RC group, a sterile rubber dam was placed to isolate the operative field and the non-carious cervical lesion restoration was performed with a nanocomposite resin (Filtek Supreme - 3M ESPE - St. Paul, MN, USA), following the manufacturer's instructions. Afterward, the both groups received a thin and small connective tissue graft that was sutured over the root/restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft. Clinical parameters were assessed at baseline and 3 and 6 months post-operatively. Statistical Analysis The null hypothesis considered in the study was the absence of difference in the clinical parameters between the different groups. For data analysis, the statistical program was used (Sigmaplot). The demographic and clinical data were compared between the groups using Student's t-test. The data were first analyzed for homogeneity using the Shapiro-Wilk test, which indicated non-normal distribution. . 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 VAS were analyzed by T-tests. The frequency of sites that were scored as very good or excellent in each group by QCE analysis, the frequency of complete root coverage, BOP, and the presence or absence of plaque at the site were compared using χ2 tests. Intergroup 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
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Connective tissue graft (CTG)
    Arm Type
    Active Comparator
    Arm Description
    After local anesthesia, the surgical procedure performed was the trapezoidal-type of CAF (de Sanctis & Zucchelli, 2007). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
    Arm Title
    Connective tissue graft plus composite resin restoration.
    Arm Type
    Experimental
    Arm Description
    After local anesthesia, the surgical procedure performed was the trapezoidal-type of CAF (de Sanctis & Zucchelli, 2007). After the flap was raised, a sterile rubber dam was placed to isolate the operative field and the non-carious cervical lesion restoration was performed with a nanocomposite resin (Filtek Supreme - 3M ESPE - St. Paul, MN, USA), following the manufacturer's instructions. Afterward, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
    Intervention Type
    Procedure
    Intervention Name(s)
    Connective tissue graft
    Other Intervention Name(s)
    Periodontal plastic surgery
    Intervention Description
    Periodontal surgical technique to treat gingival recessions
    Intervention Type
    Procedure
    Intervention Name(s)
    Composite resin restoration (Filtek Supreme - 3M)
    Other Intervention Name(s)
    Non-carious cervical lesion restoration
    Intervention Description
    Restorative procedure do treat tooth structure loss
    Primary Outcome Measure Information:
    Title
    Percentage of defect coverage
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Root coverage esthetic score
    Time Frame
    1 year

    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: presenting Miller class I or II gingival recession in the maxillary canines or premolars associated with non-carious cervical lesion; teeth included in the study should present 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 with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will 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; and
    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

    Citations:
    PubMed Identifier
    23368948
    Citation
    Santamaria MP, da Silva Feitosa D, Casati MZ, Nociti FH Jr, Sallum AW, Sallum EA. Randomized controlled clinical trial evaluating connective tissue graft plus resin-modified glass ionomer restoration for the treatment of gingival recession associated with non-carious cervical lesion: 2-year follow-up. J Periodontol. 2013 Sep;84(9):e1-8. doi: 10.1902/jop.2013.120447. Epub 2013 Jan 31.
    Results Reference
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    Composite Resin Plus Connective Tissue Graft.

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