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