Deproteinization as a Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

NCT03086720 | Unknown

• 1 other identifier: UFPEL- PPGO 0019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-carious Cervical Lesions

Keywords

Adhesive system; Controlled clinical trial; Dental restoration; Noncarious cervical lesions; Dental restoration failure; Sodium hypochlorite

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline in Post-operative sensitivity

  6, 12, 24, 36 and 60 months

• Change from baseline in marginal staining rates

  6, 12, 24, 36 and 60 months

Study Arms (2)

Sodium hypochlorite

EXPERIMENTAL

Dentin pre-treatment with a experimental solution (sodium hupochlorite), after the dentin acid etching

Procedure: Sodium hypochlorite

Water

PLACEBO COMPARATOR

Application of water (placebo) after dentin acid etching

Procedure: Water

Interventions

Sodium hypochlorite PROCEDURE

Application of 10% sodium hypochlorite (60 seconds) after the etching procedure and before the adhesive system.

Sodium hypochlorite

Water PROCEDURE

Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application

Water

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Federal University of Pelotas - School of Dentistry

Pelotas, Rio Grande do Sul, 96015560, Brazil

Location

Related Publications (3)

• 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.

  PMID: 20628774 BACKGROUND

• 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.

  PMID: 28237629 BACKGROUND

• 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.

  PMID: 35584331 DERIVED

MeSH Terms

Interventions

Sodium Hypochlorite; Water

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Hydroxides; Alkalies; Anions; Ions; Electrolytes

Study Officials

• Maximiliano Cenci, PhD

  School of Dentistry, Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: July 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 22, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)