Cervical Restorations Placed Under Two Isolation Methods

Influence of Operatory Field Isolation Techniques on the Clinical Performance of Class V Restorations

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.

Study Overview

• Status: Completed
• Conditions: Non-carious Cervical Lesions
• Intervention / Treatment: Procedure: Absolute isolation with rubber dam; Procedure: Relative isolation with cotton rolls

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Pelotas, RS, Brazil, 96015560
      • Federal University of Pelotas - School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Pelotas
• Investigators: Study Chair: Alexandre S Masotti, PhD, Federal University of Pelotas; Principal Investigator: Fernanda OB Corrêa, PhD, Federal University of Pelotas; Principal Investigator: Silvia T Fontes, PhD, Federal University of Pelotas; Principal Investigator: Maximiliano S Cenci, PhD, Federal University of Pelotas; Principal Investigator: Patricia S Jardim, PhD, Federal University of Pelotas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 30, 2011
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Treatment; Adhesives.; Composites.; Noncarious cervical lesions.; Clinical performance.
• Additional Relevant MeSH Terms: Uterine Diseases; Uterine Cervical Diseases
• Other Study ID Numbers: UFPEL-PPGO0012