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

NCT03798184 | Unknown DMC

• 1 other identifier: 2/2018
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prime&Bond Active; Bioactive glass; non-carious cervical lesion; direct resin composite

Outcome Measures

Primary Outcomes (1)

• Retention rate

  Presence of resin composite restorations of non-carious cervical lesions at the three-year follow-up examination.

  Three years

Secondary Outcomes (3)

• Marginal discoloration

  Three years

• Marginal integrity

  Three years

• Marginal caries

  Three years

Study Arms (4)

Selective-etch with bioglass surface roughening

EXPERIMENTAL

Procedure: Non-carious cervical lesion restoration

Selective-etch without bioglass surface roughening

ACTIVE COMPARATOR

Procedure: Non-carious cervical lesion restoration

Self-etch with bioglass surface roughening

EXPERIMENTAL

Procedure: Non-carious cervical lesion restoration

Self-etch without bioglass surface roughening

ACTIVE COMPARATOR

Procedure: Non-carious cervical lesion restoration

Interventions

Non-carious cervical lesion restoration PROCEDURE

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

Selective-etch with bioglass surface roughening; Selective-etch without bioglass surface roughening; Self-etch with bioglass surface roughening; Self-etch without bioglass surface roughening

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years without systemic disease.
• Presence of a non-carious cervical lesion with a minimum of 1.5 mm in depth and extent to dentin.
• Non-carious cervical lesions in premolars and molars.

You may not qualify if:

• Presence of rampant caries or advanced periodontal disease.
• Consumption of \> 2 cigarette pack/ day.
• Presence of severe xerostomia or bruxism.
• Methacrylate allergy.
• Pregnancy.
• Teeth with pulpal and/or periapical pathology, and endodontically treated teeth are excluded from the study.
• Teeth with previous pulp capping or previous class V restorations will also be excluded.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, Spain

Location

Study Design

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

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: January 9, 2019
• Study Start: November 19, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2021
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

ES (1)