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Treatment of Gingival Recession-type Defects Using Different Restorative Materials

Primary Purpose

Gingival Recession, Tooth Abrasion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
connective tissue graft+composite resin
connective tissue graft+ glass ionomer
connective tissue graft+giomer
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Cervical lesion, gingival recession, restorative materials

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Positive for the presence of three cervical lesions associated with multiple gingival recessions in three different adjacent teeth excluding molars;
  2. Miller Class I gingival recession defect (≥2 and ≤5 mm) associated with buccal NCCL (lesion depth 1-2 mm);
  3. Non-smoker;
  4. Systemically and periodontally healthy;
  5. Not taking medications known to interfere with periodontal tissue health or healing;
  6. Probing depth (PD)≤3 mm;
  7. Presence of ≥1 mm highly keratinized tissue apical to the root exposure, and presence of ≥0.8 mm-thick gingival tissue;
  8. Absence of non-vital teeth, caries or restorations on cervical areas, severe occlusal interferences and previous surgery in the area.

Exclusion Criteria:

  • inflammatory periodontal disease; previous surgical attempt to correct gingival recession; systemic disease or severe immune deficiency; coagulation defect or current anticoagulation treatment; addiction to drugs; inability or unwillingness to complete the trial; lack of linguistic skills; psychiatric disorders; refusal to sign the informed consent form; pregnancy; molar or premolar teeth with furcation involvement.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    connective tissue graft+composite resin

    connective tissue graft+ glass ionomer

    connective tissue graft+giomer

    Arm Description

    connective tissue graft plus composite resin

    connective tissue graft plus resin modified glass ionomer cement

    connective tissue graft plus giomer

    Outcomes

    Primary Outcome Measures

    relative gingival recession height
    measured as distance from the most apical point of gingival margin to the incisional border of the tooth

    Secondary Outcome Measures

    keratinized tissue width
    measured from most apical point of the gingival margin to the mucogingival junction

    Full Information

    First Posted
    May 27, 2016
    Last Updated
    May 27, 2016
    Sponsor
    Gazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02788266
    Brief Title
    Treatment of Gingival Recession-type Defects Using Different Restorative Materials
    Official Title
    Clinical Evaluation of Combined Surgical/ Restorative Treatment of Gingival Recession-type Defects Using Different Restorative Materials
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gazi University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: The aim of this study was to evaluate the treatment of multiple gingival recessions associated with non-carious cervical lesions (NCCL) using a modified coronally advanced flap in combination with a sub-epithelial connective tissue graft (SCTG) on restored root surfaces. Methods: Twenty-three systemically healthy subjects, who were positive for the presence of three cervical lesions associated with gingival recessions in three different adjacent teeth, were enrolled in the study. The NCCL were each restored prior to surgery by using one of three different materials: composite resin (group 1), resin-modified glass ionomer cement (group 2) or giomer (group 3). The defects were treated with SCTG. Clinical measurements, including plaque index (PI), bleeding on probing (BOP), relative recession height (rRH), probing depth (PD), cervical lesion height (CLH), relative clinical attachment level (rCAL), keratinized tissue height (KTH), keratinized tissue thickness (KTT), percentage of root coverage (RC), and percentage of cervical lesion height coverage (CLHC) were recorded at baseline, 3 and 6 months, and 1 year postoperatively.
    Detailed Description
    Gingival recession (GR) is defined as exposure of the root surface due to displacement of the gingival margin apical to the cemento-enamel junction (CEJ). Problems related to gingival recessions are dentin hypersensitivity, bacterial plaque accumulation, difficulty of maintaining oral health care and aesthetics, root caries and abrasions and fear of losing teeth6. Coronally advanced flap (CAF) is an effective periodontal plastic surgical procedure for the treatment of gingival recessions. The CAF with a subepithelial connective tissue graft (CAF+ SCTG) technique is reported as the gold standard and does enhance the probability of achieving complete root coverage. Various dental materials and surgical approaches have been used to manage gingival recessions associated with cervical lesions for the most predictable combined surgical/restorative treatment.Restorative materials must be biocompatible to minimize their adverse effects on periodontal tissues induced by direct contact.Resin composites or resin modified glass ionomer cements have been commonly used to restore cervical lesions.Resin-ionomer materials have many properties such as biocompatibility with soft and hard tissues and displaying high marginal adaptation and minimal surface roughness as well as allowing them to be used successfully in the subgingival region. Composite resin materials have many advantages including aesthetics and surface characteristics in terms of finishing and polishing. It has been reported that well-adapted and finished composite resins seem have no adverse effects on the periodontal margin. It has also been reported that the ageing of the composite resin restorations may produce gingival inflammation in subgingival areas. Fluoride-releasing resin materials with pre-reacted glass (PRG), called giomer, has been suggested to have good color matching, biocompatibility, smooth surface finish, fluoride release and fluoride recharge potential. It was reported in a randomized-controlled clinical trial that the use of CTG for treatment of root surfaces restored with giomer was effective over the 6-month period without any noxious effect on periodontal tissues. Therefore, the aim of this study was to evaluate clinically the treatment of gingival recession associated with NCCL in resin modified glass ionomer cement (RMGI) or nano-filled resin composite (NRC) or giomer plus SCTG in the first year following surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession, Tooth Abrasion
    Keywords
    Cervical lesion, gingival recession, restorative materials

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    connective tissue graft+composite resin
    Arm Type
    Active Comparator
    Arm Description
    connective tissue graft plus composite resin
    Arm Title
    connective tissue graft+ glass ionomer
    Arm Type
    Active Comparator
    Arm Description
    connective tissue graft plus resin modified glass ionomer cement
    Arm Title
    connective tissue graft+giomer
    Arm Type
    Active Comparator
    Arm Description
    connective tissue graft plus giomer
    Intervention Type
    Procedure
    Intervention Name(s)
    connective tissue graft+composite resin
    Intervention Description
    treatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus composite resin
    Intervention Type
    Procedure
    Intervention Name(s)
    connective tissue graft+ glass ionomer
    Intervention Description
    treatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus resin modified glass ionomer cement
    Intervention Type
    Procedure
    Intervention Name(s)
    connective tissue graft+giomer
    Intervention Description
    treatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus giomer
    Primary Outcome Measure Information:
    Title
    relative gingival recession height
    Description
    measured as distance from the most apical point of gingival margin to the incisional border of the tooth
    Time Frame
    one year post-op
    Secondary Outcome Measure Information:
    Title
    keratinized tissue width
    Description
    measured from most apical point of the gingival margin to the mucogingival junction
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Positive for the presence of three cervical lesions associated with multiple gingival recessions in three different adjacent teeth excluding molars; Miller Class I gingival recession defect (≥2 and ≤5 mm) associated with buccal NCCL (lesion depth 1-2 mm); Non-smoker; Systemically and periodontally healthy; Not taking medications known to interfere with periodontal tissue health or healing; Probing depth (PD)≤3 mm; Presence of ≥1 mm highly keratinized tissue apical to the root exposure, and presence of ≥0.8 mm-thick gingival tissue; Absence of non-vital teeth, caries or restorations on cervical areas, severe occlusal interferences and previous surgery in the area. Exclusion Criteria: inflammatory periodontal disease; previous surgical attempt to correct gingival recession; systemic disease or severe immune deficiency; coagulation defect or current anticoagulation treatment; addiction to drugs; inability or unwillingness to complete the trial; lack of linguistic skills; psychiatric disorders; refusal to sign the informed consent form; pregnancy; molar or premolar teeth with furcation involvement.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    gonen ozcan, Ph D
    Organizational Affiliation
    Prof.dr.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Treatment of Gingival Recession-type Defects Using Different Restorative Materials

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