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Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

Information source: Federal University of Pelotas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-carious Cervical Lesions

Intervention: Treatment with chlorhexidine (Procedure); Water pre-treatment (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Federal University of Pelotas

Official(s) and/or principal investigator(s):
Maximiliano Cenci, PhD, Principal Investigator, Affiliation: School of Dentistry-UFPel

Overall contact:
Maximiliano Cenci, PhD, Phone: +55 53 32226690, Ext: 134, Email: cencims@gmail.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from baseline in Retention rates of the restoration at 24 months

Secondary outcome:

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Maximiliano Cenci, PhD, Phone: +55 53 32226690, Ext: 134, Email: cencims@gmail.com

School of Dentistry, Federal University of Pelotas, Pelotas, RS 96015-560, Brazil; Recruiting
Maximiliano Cenci, PhD, Phone: +55 53 32226690, Ext: 134, Email: cencims@gmail.com
Anelise Montagner, PhD Student, Sub-Investigator
Maximiliano Cenci, PhD, Principal Investigator
Additional Information

Related publications:

Hickel R, Peschke A, Tyas M, Mjör 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.

Starting date: November 2011
Last updated: September 17, 2013

Page last updated: August 23, 2015

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