Clinical trial NCT01947192: Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions
Official title: Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions and Failure-prognostic Variables: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-carious Cervical Lesions
Keywords: Chlorhexidine
Matrix metalloproteinases (MMP) inhibitor
Adhesive system
Controlled clinical trial
Dental restoration
Noncarious cervical lesions
Dental restoration failure
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in Retention rates of the restoration at 24 months
timeFrame: 6, 12 and 24 months
Secondary outcomes:
measure: Change from baseline in Post-operative sensitivity at 6-month
timeFrame: baseline and 6-month
measure: Change from baseline in marginal staining rates at 6. 12 and 24 months
timeFrame: 6, 12 and 24 months
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: School of Dentistry, Federal University of Pelotas
state: RS
Study officials:
affiliation: School of Dentistry-UFPel
name: Maximiliano Cenci, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.