Deproteinization as a Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

Non-carious Cervical Lesions Clinical Trial

Official title:

Effect of Sodium Hypochlorite Pre-treatment on the Retention of Restorations for Non-carious Cervical Lesions: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03086720
• Other study ID #: UFPEL- PPGO 0019
• Status: Active, not recruiting
• Phase: N/A
• First received: March 16, 2017
• Last updated: March 16, 2017
• Start date: July 2012
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will verify the effect of the application of a substance (10% sodium hypoclorite -NaOCL) in dentin on noncarious cervical lesions, with the aim of increasing the longevity of the restorations performed in this type of lesion.

The hypothesis of the present study is that the application of deproteinization solution after acid etching does not influence the failure rate of the restorations.

Description:

The purpose of this study will be to evaluate the failure rates of composite restorations of non-carious cervical lesions (NCCL) performed with or without the pre-treatment with 10% sodium hypochlorite (NaOCl) on etched dentin.

A randomized controlled split-mouth and double blind clinical trial will be carried out. Patients with at least two NCCL will be selected. Each patient will be received at least one pair of composite restorations (Filtek Z350/3M ESPE), bonded either with 2 techniques: control (acid etching + placebo solution for 60 seconds + Adper Single Bond 2/3M ESPE) or experimental (acid etching + 10% NaOCl for 60 seconds + Adper Single Bond 2). A calibrated examiner will be evaluated the restorations (baseline, 6-, 12-, 24- and 36-month) using the FDI criteria. The primary outcome is retention of the restoration.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• 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 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.

Related Conditions & MeSH terms

• Non-carious Cervical Lesions
• Uterine Cervical Diseases

Intervention

Procedure:
• Sodium hypochlorite
Application of 10% sodium hypochlorite (60 seconds) after the etching procedure and before the adhesive system.
• Water
Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Favetti M, Schroeder T, Montagner AF, Correa MB, Pereira-Cenci T, Cenci MS. Effectiveness of pre-treatment with chlorhexidine in restoration retention: A 36-month follow-up randomized clinical trial. J Dent. 2017 Feb 22. pii: S0300-5712(17)30052-0. doi: 10.1016/j.jdent.2017.02.014. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Retention rates of the restoration	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, 24, 36 and 60 months
Secondary	Change from baseline in Post-operative sensitivity	At each time-point, patients will be recalled and interviewed regarding any symptom related to each restorations placed.	6, 12, 24, 36 and 60 months
Secondary	Change from baseline in marginal staining rates	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, 24, 36 and 60 months