Skip to main content
OpenTrials
Completed

NCT Number: NCT01947192

Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

This study aims to evaluate the effect of chlorhexidine digluconate (CRX) application in etched dentin on the retention of noncarious cervical lesions restorations.

A randomized controlled split-mouth and blind trial will be carried out. Patients with at least two non-carious cervical lesions (NCL) will be selected. NCL will be randomly assigned according the type of teeth (incisors, canine or pre-molars) into two groups: control or experimental group (application of 2% CRX for 60 seconds after the acid etching procedure). Class V restorations will be performed out with an etch-and-rinse adhesive system (Adper Single Bond 2-3M ESPE) and a composite resin (Filtek Z350-3M ESPE) according the manufacture instructions, by previously trained operators. The restorations will be evaluated by a calibrate examiner at 1 week (baseline), and 6-month, 12-month and 24-month, using the World Dental Federation (FDI) criteria. The outcome is retention of the restoration.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-carious Cervical Lesions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015-560, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients presenting at least two non-carious cervical lesions (NCL) in anterior, canine or pre-molars;
  • Patients who had more than 20 teeth in the mouth;
  • Patients who were at least 18 years of age at the time of treatment and capable to understand and sign the written informed consent;
  • NCL with at least 1 mm of depth in a vital permanent incisor, canine or premolar of the upper as the lower jaw.
  • NCL in the facial surface of the teeth with sometimes a small part extending interproximally;
  • Patients with good periodontal heath.

Exclusion criteria

  • Patients with smoking habits, practicing bruxism, severe systemic diseases, using active orthodontic treatment, malocclusion (Angle Class II or Class III);
  • Tooth with the NCL with the absent of antagonist;
  • NCL wear facets upper than 50% of the incisal/occlusion surface, as a result of tooth attrition;
  • Presence of caries or restorations in the area to be treated;
  • Full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index upper than 20%, probing depth and clinical attachment loss values exceeding 4 mm with bleeding on probing;
  • Unwillingness to return for follow-ups or refuse to participate.

Treatment and study plan

Treatment with chlorhexidine

Procedure

Application of 2% chlorhexidine digluconate (60 seconds) after the etching procedure and before the adhesive system.

Water pre-treatment

Procedure

Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application

Primary outcomes

  1. Change from baseline in Retention rates of the restoration at 24 months

    Time frame: 6, 12 and 24 months

    Patients will be reevaluated at each specified time point and all restoration sites will be evaluated to check if the restoration will be still in place, or if it is missing, or if there is partial retention

Secondary outcomes

  1. Change from baseline in Post-operative sensitivity at 6-month

    Time frame: baseline and 6-month

    At each time-point, patients will be recalled and interviewed regarding any symptom related to each restorations placed.

  2. Change from baseline in marginal staining rates at 6. 12 and 24 months

    Time frame: 6, 12 and 24 months

    At each time-point, patients will be recalled and restorations will be reassessed in order to record changes in the rates of marginal staining, using the World Dental Federation (FDI) criteria for restorations assessment (Hickel et al 2010).

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Registry information

Official study title

Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions and Failure-prognostic Variables: A Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2012
First posted
Sep 20, 2013
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.