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Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

F

Federal University of Pelotas

Status

Completed

Conditions

Non-carious Cervical Lesions

Treatments

Procedure: Treatment with chlorhexidine
Procedure: Water pre-treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01947192
PPGO0017

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups, including a placebo group

Chlorhexidine
Experimental group
Description:
Dentin pre-treatment with a experimental solution (chlorhexidine), after the dentin acid etching
Treatment:
Procedure: Treatment with chlorhexidine
Water
Placebo Comparator group
Description:
Application of water (placebo) after dentin acid etching.
Treatment:
Procedure: Water pre-treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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