Cervical Restorations Placed Under Two Isolation Methods

Federal University of Pelotas30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Non-carious Cervical Lesions

Interventions

Relative isolation with cotton rollsPROCEDURE

Cotton roll group: Moisture control was provided using a labial retractor, cotton rolls and gingival retraction cord placed into the gingival sulcus

Absolute isolation with rubber damPROCEDURE

Rubber dam group: Moisture control was provided by a rubber dam and a gingival retraction clamp placed in the cervical area of the tooth.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: up to 72 months

Secondary Outcomes

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.

Time frame: 6, 12, 24, 48 and 72 months after restorations' placement