Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01947192
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : February 24, 2016
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Non-carious Cervical Lesions Procedure: Treatment with chlorhexidine Procedure: Water pre-treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions and Failure-prognostic Variables: A Randomized Controlled Trial
Study Start Date : November 2011
Actual Primary Completion Date : November 2012

Arm Intervention/treatment
Experimental: Chlorhexidine
Dentin pre-treatment with a experimental solution (chlorhexidine), after the dentin acid etching
Procedure: Treatment with chlorhexidine
Application of 2% chlorhexidine digluconate (60 seconds) after the etching procedure and before the adhesive system.

Placebo Comparator: Water
Application of water (placebo) after dentin acid etching.
Procedure: Water pre-treatment
Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application

Primary Outcome Measures :
  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 Outcome Measures :
  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).

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01947192

School of Dentistry, Federal University of Pelotas
Pelotas, RS, Brazil, 96015-560
Sponsors and Collaborators
Federal University of Pelotas
Principal Investigator: Maximiliano Cenci, PhD School of Dentistry-UFPel

Responsible Party: Maximiliano Sergio Cenci, Associate Professor, Federal University of Pelotas Identifier: NCT01947192     History of Changes
Other Study ID Numbers: PPGO0017
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016

Keywords provided by Maximiliano Sergio Cenci, Federal University of Pelotas:
Matrix metalloproteinases (MMP) inhibitor
Adhesive system
Controlled clinical trial
Dental restoration
Noncarious cervical lesions
Dental restoration failure

Additional relevant MeSH terms:
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents