Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

NCT01947192 | Completed

• 1 other identifier: PPGO0017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-carious Cervical Lesions

Keywords

Chlorhexidine; Matrix metalloproteinases (MMP) inhibitor; Adhesive system; Controlled clinical trial; Dental restoration; Noncarious cervical lesions; Dental restoration failure

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Retention rates of the restoration at 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

  6, 12 and 24 months

Secondary Outcomes (2)

• Change from baseline in Post-operative sensitivity at 6-month

  baseline and 6-month

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

  6, 12 and 24 months

Study Arms (2)

Chlorhexidine

EXPERIMENTAL

Dentin pre-treatment with a experimental solution (chlorhexidine), after the dentin acid etching

Procedure: Treatment with chlorhexidine

Water

PLACEBO COMPARATOR

Application of water (placebo) after dentin acid etching.

Procedure: Water pre-treatment

Interventions

Treatment with chlorhexidine PROCEDURE

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

Chlorhexidine

Water pre-treatment PROCEDURE

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

Water

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

School of Dentistry, Federal University of Pelotas

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

Location

Related Publications (1)

• Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.

  PMID: 20628774 BACKGROUND

MeSH Terms

Interventions

Therapeutics; Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Maximiliano Cenci, PhD

  School of Dentistry-UFPel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: September 20, 2013
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

BR (1)