Clinical trial NCT03086720: Deproteinization as a Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions
Official title: Effect of Sodium Hypochlorite Pre-treatment on the Retention of Restorations for Non-carious Cervical Lesions: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-carious Cervical Lesions
Keywords: Adhesive system
Controlled clinical trial
Dental restoration
Noncarious cervical lesions
Dental restoration failure
Sodium hypochlorite
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 30
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 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.

Detailed 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.

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 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
timeFrame: 6, 12, 24, 36 and 60 months
Secondary outcomes:
measure: Change from baseline in Post-operative sensitivity
timeFrame: 6, 12, 24, 36 and 60 months
measure: Change from baseline in marginal staining rates
timeFrame: 6, 12, 24, 36 and 60 months
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas - School of Dentistry
state: RS
Study officials:
affiliation: School of Dentistry, Federal University of Pelotas
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.
citation: 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 May;60:44-49. doi: 10.1016/j.jdent.2017.02.014. Epub 2017 Feb 22.
citation: Favetti M, Schroeder T, Montagner AF, Moraes RR, Pereira-Cenci T, Cenci MS. NaOCl Application after Acid Etching and Retention of Cervical Restorations: A 3-Year Randomized Clinical Trial. Oper Dent. 2022 May 1;47(3):268-278. doi: 10.2341/20-166-C.