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Cervical Restorations Placed Under Two Isolation Methods

NCT01506830 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-02-24

No results posted yet for this study

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.

Conditions

  • Non-carious Cervical Lesions

Interventions

PROCEDURE

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

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.

Sponsors & Collaborators

  • Federal University of Pelotas

    lead OTHER

Principal Investigators

  • Alexandre S Masotti, PhD · Federal University of Pelotas

  • Fernanda OB Corrêa, PhD · Federal University of Pelotas

  • Silvia T Fontes, PhD · Federal University of Pelotas

  • Maximiliano S Cenci, PhD · Federal University of Pelotas

  • Patricia S Jardim, PhD · Federal University of Pelotas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-07-31
Completion
2011-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01506830 on ClinicalTrials.gov