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Clinical Performance of Prime&Bond Active in Self-etch or Selective-etch Mode With or Without Bioglass

NCT03798184 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2019-01-09

No results posted yet for this study

Summary

Composite restoration of non-carious cervical lesions has always been a challenge for the clinician, considering that the most frequent cause of failure is retention loss.

Adhesion of composite restoration may be obtained by following four different etching techniques: total-etch in three steps, total-etch in two steps, self-etch in two steps, and self-etch in one step. Nowadays the tendency is to simplify the adhesive classic protocols. With the introduction of universal adhesives such as Prime\&Bond Active (Dentsply Sirona) it is possible to obtain a total-etch pattern (enamel and dentine) without the classic etching technique with orthophosphoric acid.

On the other hand, there has been an increase in the awareness of the importance of remaining dental tissue preservation, avoiding preparation of a cavity. This is why it is now preferable to use bioactive glass in order to increase micromechanical retention on the dental surface, instead of the classical approach of preparing the surface with burs.

To date, there are no studies evaluating the clinical performance of the universal adhesive Prime\&Bond Active on direct resin composite restoration of non-carious cervical lesions neither in a selective-etch mode (enamel etching) or a self-etch mode (no etching) or using sandblasting with bioactive glass. Therefore, the main objective of the study is to evaluate the retention rate of composite restorations using Prime\&Bond Active and a previous sandblasted surface with bioglass in a three-year follow-up, as well as the presence of marginal discoloration, marginal integrity and marginal caries.

Conditions

  • Self-etch
  • Selective-etch
  • Bioactive Glass
  • Direct Resin Composite Restoration
  • Non-carious Cervical Lesion
  • Universal Adhesive

Interventions

PROCEDURE

Non-carious cervical lesion restoration

Restoration of non-carious cervical lesions with Prime\&Bond Active in self-etch or selective-etch mode with or without bioglass

Sponsors & Collaborators

  • University of Valencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2019-11-30
Completion
2021-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03798184 on ClinicalTrials.gov