Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

Non-carious Cervical Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947192
• Other study ID #: PPGO0017
• Status: Completed
• Phase: N/A
• First received: August 15, 2013
• Last updated: February 23, 2016
• Start date: November 2011

Study information

• Verified date: February 2016
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Non-carious Cervical Lesions
• Uterine Cervical Diseases

Intervention

Procedure:
• Treatment with chlorhexidine
Application of 2% chlorhexidine digluconate (60 seconds) after the etching procedure and before the adhesive system.
• Water pre-treatment
Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application

Locations

Country	Name	City	State
Brazil	School of Dentistry, Federal University of Pelotas	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline in Post-operative sensitivity at 6-month	At each time-point, patients will be recalled and interviewed regarding any symptom related to each restorations placed.	baseline and 6-month	Yes
Secondary	Change from baseline in marginal staining rates at 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).	6, 12 and 24 months	No