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-monthChange 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
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