Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Federal University of Pelotas
Sponsor:
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT01947192
First received: August 15, 2013
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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 Intervention
Non-carious Cervical Lesions
Procedure: Treatment with chlorhexidine
Procedure: Water pre-treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Federal University of Pelotas:

Primary Outcome Measures:
  • Change from baseline in Retention rates of the restoration at 24 months [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    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:
  • Change from baseline in Post-operative sensitivity at 6-month [ Time Frame: baseline and 6-month ] [ Designated as safety issue: Yes ]
    At each time-point, patients will be recalled and interviewed regarding any symptom related to each restorations placed.

  • Change from baseline in marginal staining rates at 6. 12 and 24 months [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 50
Study Start Date: November 2011
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947192

Contacts
Contact: Maximiliano Cenci, PhD +55 53 32226690 ext 134 cencims@gmail.com

Locations
Brazil
School of Dentistry, Federal University of Pelotas Recruiting
Pelotas, RS, Brazil, 96015-560
Contact: Maximiliano Cenci, PhD    +55 53 32226690 ext 134    cencims@gmail.com   
Sub-Investigator: Anelise Montagner, PhD Student         
Principal Investigator: Maximiliano Cenci, PhD         
Sponsors and Collaborators
Federal University of Pelotas
Investigators
Principal Investigator: Maximiliano Cenci, PhD School of Dentistry-UFPel
  More Information

Publications:
Responsible Party: Maximiliano Sergio Cenci, Associate Professor, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT01947192     History of Changes
Other Study ID Numbers: PPGO0017
Study First Received: August 15, 2013
Last Updated: September 17, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Pelotas:
Chlorhexidine
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
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on July 29, 2014