Cervical Restorations Placed Under Two Isolation Methods

Study Overview
=================
Brief Summary
-----------------
During restorative procedures, different isolation methods of the operative field can be used to promote moisture control and retraction of the gingival tissues. The aim of the present clinical trial is to evaluate the effects of two isolation techniques on the clinical performance of Class V restorations, as well on the periodontal conditions of restored sites. Patients presenting at least two noncarious cervical lesions (NCLs) will be enrolled in this study. The NCLs will be randomized into the following groups: (1) isolation performed with rubber dam and gingival retraction clamp and (2) isolation provided with cotton rolls and gingival retraction cord. Both techniques will be used with a saliva suction device. All restorative procedures were performed using a self-etching adhesive system and a nanofilled composite resin according to the manufacturer's instructions. The clinical performance of restorations will be recorded in terms of fracture and retention of restoration, marginal adaptation, marginal staining, postoperative hypersensitivity, and preservation of tooth vitality at 1 week, 6 months, 12, 24 and 72 months after placement. The periodontal condition of restored sites will be evaluated based on the presence of supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival recession.

Official Title
-----------------
Influence of Operatory Field Isolation Techniques on the Clinical Performance of Class V Restorations

Conditions
-----------------
Non-carious Cervical Lesions

Intervention / Treatment
-----------------
* Procedure: Relative isolation with cotton rolls
* Procedure: Absolute isolation with rubber dam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than one cervical lesion lesions whose apical limit located above the gingival margin lesions with at least 1 mm of depth vital permanent incisors, canines, or premolars Exclusion Criteria: smoking habits severe systemic diseases active orthodontic treatment malocclusion (Angle Class II or Class III) less than 20 natural teeth in mouth absent of antagonist tooth wear facets over more than 50% of the incisal/occlusion surface as a result of tooth attrition or restorations in the area to be treated full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index (GBI) more than 20% probing depth (PD) and clinical attachment loss (CAL) values exceeding 4 mm with bleeding on probing (BOP) unwillingness to return for follow-ups or refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Absolute isolation<br>Absolute isolation of the operatory field with rubber dam: Moisture control is provided by a rubber dam and a gingival retraction clamp placed in the cervical area of the tooth. | Procedure: Absolute isolation with rubber dam<br>* Rubber dam group: Moisture control was provided by a rubber dam and a gingival retraction clamp placed in the cervical area of the tooth.<br>|
| Experimental: Relative isolation<br>Relative isolation of the operatory field with cotton rolls: Moisture control was provided using a labial retractor, cotton rolls and gingival retraction cord placed into the gingival sulcus | Procedure: Relative isolation with cotton rolls<br>* Cotton roll group: Moisture control was provided using a labial retractor, cotton rolls and gingival retraction cord placed into the gingival sulcus<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retention of restorations | Retention of restorations is measured by clinical examination, where each placed restoration is checked and scored as present, partially lost or lost at the recalls. | up to 72 months | 
| Restorations marginal staining | Restorations are checked during recalls regarding the marginal staining and scored as clinically ideal, clinically acceptable; presence of small ditching; presence of extensive marginal ditching and need for repair /replacement. | up to 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal condition of restored sites | The periodontal condition of restored sites is evaluated based on the presence of supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival recession. | 6, 12, 24, 48 and 72 months after restorations' placement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adhesives., Composites., Noncarious cervical lesions., Clinical performance., Treatment