NCT01506830|CompletedPhase 2/3
Cervical Restorations Placed Under Two Isolation Methods
Influence of Operatory Field Isolation Techniques on the Clinical Performance of Class V Restorations
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Influence of Operatory Field Isolation Techniques on the Clinical Performance of Class V Restorations
Sponsor study identifier
interventional
30
1 country
1
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2011
Actual (reported)Study Completion
December 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 2011
Actual (reported)December 2011
Actual (reported)December 30, 2011
Actual (reported)January 10, 2012
Actual (reported)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.
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.
up to 72 months
Periodontal condition of restored sites
6, 12, 24, 48 and 72 months after restorations' placement
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 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
Cotton roll group: Moisture control was provided using a labial retractor, cotton rolls and gingival retraction cord placed into the gingival sulcus
Rubber dam group: Moisture control was provided by a rubber dam and a gingival retraction clamp placed in the cervical area of the tooth.
Federal University of Pelotas - School of Dentistry
Pelotas, Rio Grande do Sul, 96015560, Brazil
Favetti M, Montagner AF, Fontes ST, Martins TM, Masotti AS, Jardim PDS, Correa FOB, Cenci MS, Muniz FWMG. Effects of cervical restorations on the periodontal tissues: 5-year follow-up results of a randomized clinical trial. J Dent. 2021 Mar;106:103571. doi: 10.1016/j.jdent.2020.103571. Epub 2020 Dec 29.
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
30 participants (actual enrollment reported by the registry).
First Submitted
December 30, 2011
First Posted
January 10, 2012
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Preheated Composites Vs. Conventional Composites in Noncarious Cervical Lesions
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Patricia S Jardim, PhD
Federal University of Pelotas
Primary Completion
July 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
February 24, 2016
Record last verified: 2016-02
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