A New Surgical-restorative Approach to Treat Gingival Recessions Associated With Non-carious Cervical Lesions (NCCL)

Study Overview
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Brief Summary
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The aim of the present study is to evaluate the clinical, aesthetic and patient-centered parameters of connective tissue graft associated or not with partial resin composite (RC) for the treatment of gingival recession with NCCL, performed before the surgical procedure.

Detailed Description
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This was a prospective, parallel and controlled clinical trial. - Group CTG (control n = 20) - patients who received connective tissue graft to treat gingival recession associated with non-carious cervical lesion. Group CTG+RC (test n = 20) - patients who received connective tissue graft plus partial 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 Institute of Science and Technology (ICT), State University of São Paulo (UNESP). For those recessions allocated to CTG group, 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. Afterwards, a thin and small connective tissue graft was removed from the palatal site and sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft. For those recessions allocated to CTG+RC group, firstly a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter apically to the cemento-enamel junction estimation. In the following session the CTG+RC received the surgical procedure as described above where a thin and small connective tissue graft was removed from the palatal site and 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.

Official Title
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Evaluation of a New Surgical-restorative Approach for the Treatment of Gingival Recessions Associated With Non-carious Cervical Lesions: a Randomized Controlled Clinical Trial

Conditions
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Gingival Recession, Tooth Abrasion

Intervention / Treatment
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* Procedure: Connective tissue graft (CTG)
* Procedure: CTG plus resin composite restoration
* Drug: sodium dipyrone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Connective tissue graft (CTG)<br>After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). 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. | Procedure: Connective tissue graft (CTG)<br>* Periodontal surgical technique to treat gingival recessions<br>* Other names: Periodontal plastic surgery;Drug: sodium dipyrone<br>* sodium dipyrone was recommended for all participants after the surgical procedures.<br>|
| Experimental: CTG plus resin composite restoration<br>After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, 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. | Procedure: CTG plus resin composite restoration<br>* Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss<br>* Other names: Periodontal plastic surgery;Drug: sodium dipyrone<br>* sodium dipyrone was recommended for all participants after the surgical procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Defect Coverage | Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Root Coverage Esthetic Score (MRES) | The MRES evaluated six variables: gingival margin (GM): 0 or 3 points; marginal tissue contour (MTC): 0 or 1 point; soft tissue texture (STT): 0 or 1 point; mucogingival junction alignment (MGJ): 0 or 1 point; gingival color (GC): 0 or 1 point; restoration/cervical lesion color (R/CLC): 0 points = color of restoration or uncovered cervical lesion does not match with tooth's color; 3 points = good color integration. Thus, 10 points was a perfect score. | 6 months |