Cervical Restorations Placed Under Two Isolation Methods

Phase 2

Completed

• Conditions: Non-carious Cervical Lesions
• Interventions: Procedure: Absolute isolation with rubber dam; Procedure: Relative isolation with cotton rolls

• Registration Number: NCT01506830
• Lead Sponsor: Federal University of Pelotas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2011-07
• Study Completion: 2011-12
• Study First Submitted: 2011-12-30
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-10
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absolute isolation	Absolute isolation with rubber dam	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.
Relative isolation	Relative isolation with cotton rolls	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

Primary Outcome Measures

Name	Time	Method
Restorations marginal staining	up to 72 months	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.
retention of restorations	up to 72 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Federal University of Pelotas - School of Dentistry; 🇧🇷 Pelotas, RS, Brazil