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Completed

NCT Number: NCT01506830

Cervical Restorations Placed Under Two Isolation Methods

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.

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Key information

Conditions

Non-carious Cervical Lesions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Federal University of Pelotas - School of Dentistry

Pelotas, Rio Grande do Sul, 96015560, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. retention of restorations

    Time frame: up to 72 months

    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.

  2. Restorations marginal staining

    Time frame: up to 72 months

    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 outcomes

  1. Periodontal condition of restored sites

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

    The periodontal condition of restored sites is evaluated based on the presence of supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival recession.

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 10, 2012
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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