Cervical Restorations Placed Under Two Isolation Methods

NCT01506830 | Completed Phase 2

• 1 other identifier: UFPEL-PPGO0012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-carious Cervical Lesions

Keywords

Adhesives.; Composites.; Noncarious cervical lesions.; Clinical performance.; Treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Periodontal condition of restored sites

  6, 12, 24, 48 and 72 months after restorations' placement

Study Arms (2)

Absolute isolation

ACTIVE COMPARATOR

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

Relative isolation

EXPERIMENTAL

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

Interventions

Relative isolation with cotton rolls PROCEDURE

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

Relative isolation

Absolute isolation with rubber dam 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.

Absolute isolation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Federal University of Pelotas - School of Dentistry

Pelotas, Rio Grande do Sul, 96015560, Brazil

Location

Related Publications (1)

• 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.

  PMID: 33385534 DERIVED

MeSH Terms

Interventions

Rubber Dams

Intervention Hierarchy (Ancestors)

Dental Equipment; Dentistry; Equipment and Supplies

Study Officials

• Alexandre S Masotti, PhD

  Federal University of Pelotas

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Coordinator of Clinical Trials, Graduate Program in Dentistry

Study Record Dates

• First Submitted: December 30, 2011
• First Posted: January 10, 2012
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

BR (1)