Cervical Restorations Placed Under Two Isolation Methods

Federal University of Pelotas

Status and phase: Completed; Phase 3; Phase 2

Conditions: Non-carious Cervical Lesions

Treatments: Procedure: Relative isolation with cotton rolls; Procedure: Absolute isolation with rubber dam

Study type: Interventional

Funder types: Other

Identifiers

NCT01506830

UFPEL-PPGO0012

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Absolute isolation

Active Comparator group

Description:

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.

Treatment:

Procedure: Absolute isolation with rubber dam

Relative isolation

Experimental group

Description:

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

Treatment:

Procedure: Relative isolation with cotton rolls