Clinical trial NCT02788266: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Tooth Abrasion
Keywords: Cervical lesion
gingival recession
restorative materials
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: relative gingival recession height
timeFrame: one year post-op
Secondary outcomes:
measure: keratinized tissue width
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Prof.dr.
name: gonen ozcan, Ph D
role: STUDY_DIRECTOR
References: