Cervical Restorations Placed Under Two Isolation Methods

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-carious Cervical Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Absolute isolation

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.

Group Type ACTIVE_COMPARATOR

Absolute isolation with rubber dam

Intervention Type PROCEDURE

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

Relative isolation

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

Group Type EXPERIMENTAL

Relative isolation with cotton rolls

Intervention Type PROCEDURE

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

Interventions

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Relative isolation with cotton rolls

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

Intervention Type PROCEDURE

Absolute isolation with rubber dam

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes