Cervical Restorations Placed Under Two Isolation Methods

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT01506830
First received: December 30, 2011
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Non-carious Cervical Lesions
Procedure: Relative isolation with cotton rolls
Procedure: Absolute isolation with rubber dam
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Operatory Field Isolation Techniques on the Clinical Performance of Class V Restorations

Further study details as provided by Federal University of Pelotas:

Primary Outcome Measures:
  • retention of restorations [ Time Frame: up to 72 months ] [ Designated as safety issue: No ]
    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.

  • Restorations marginal staining [ Time Frame: up to 72 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Periodontal condition of restored sites [ Time Frame: 6, 12, 24, 48 and 72 months after restorations' placement ] [ Designated as safety issue: No ]
    The periodontal condition of restored sites is evaluated based on the presence of supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival recession.


Enrollment: 30
Study Start Date: July 2009
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01506830

Locations
Brazil
Federal University of Pelotas - School of Dentistry
Pelotas, RS, Brazil, 96015560
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Maximiliano Sergio Cenci, PhD, Coordinator of Clinical Trials, Graduate Program in Dentistry, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT01506830     History of Changes
Other Study ID Numbers: UFPEL-PPGO0012
Study First Received: December 30, 2011
Last Updated: July 19, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Pelotas:
Adhesives.
Composites.
Noncarious cervical lesions.
Clinical performance.
Treatment

ClinicalTrials.gov processed this record on October 23, 2014