Effect of Wet and Overwet Dentin on the Clinical Performance of Two Universal Adhesive Systems

NCT ID: NCT07034235

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2025-03-10

Brief Summary

The aim of this study will be to evaluate the effect of wet and overwet dentin on the long-term clinical performance of two universal adhesive systems used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs).

Materials & Methods: 200 restorations will be randomly placed in 50 subjects according to the following groups (n=50): AMP-wet (Ambar Universal APS Plus adhesive on wet dentin); AMP-overwet (Ambar Universal APS Plus adhesive on oversaturated dentin); PBA-wet (Prime&Bond Active adhesive on wet dentin); PBA-overwet (Prime&Bond Active adhesive on oversaturated dentin). For all groups, the enamel and dentin will be etched for 15s. All groups will be light-cured for 10s/1,000 mW/cm2. A resin composite will be placed by applying three increments and each one was light cured for 20s/1,000 mW/cm2. The restorations will be finished immediately with fine diamond burs and spiral polishers. The restorations will be evaluated at baseline and after 6 months by using the FDI criteria. The following outcomes will be evaluated: retention, marginal staining, marginal adaptation, post-operative sensitivity and recurrence of caries. The differences among the groups will be calculated using Friedman repeated measures analysis of variance rank (α = 0.05).

Detailed Description

This is a four-arm, double-blind, randomized controlled clinical trial.

Control group 1: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Ambar Universal APS Plus; FGM) on wet dentin in the etch-and-rinse application strategy.

Control group 2: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Prime&Bond Active; Dentsply Sirona) on wet dentin in the etch-and-rinse application strategy.

Experimental group 1: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Ambar Universal APS Plus; FGM) on overwet dentin in the etch-and-rinse application strategy.

Experimental group 2: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Prime&Bond Active; Dentsply Sirona) on overwet dentin in the etch-and-rinse application strategy

LCNCs will be randomized to universal adhesive usage and dentinal moisture levels. All groups will be light-cured with a lightcuring device (Quazar, FGM) with a light intensity of 900 mW/cm² for 10 seconds. Operators will restore the cervical area by applying three increments of resin (Llis-FGM for experimental groups 1 and 2; and TPH Spectrum-Dentsply for experimental groups 3 and 4). Each increment will light cure for 20 s at 900 mW/cm2 (Quazar, FGM). Restorations will be finished immediately with fine and extra fine diamond burs and polished with polishing spirals.

Conditions

Non-carious Cervical Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group 1

50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.

Group Type: EXPERIMENTAL

Dentin Overwet

Intervention Type: PROCEDURE

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on overwet dentin in the etch-and-rinse application strategy.

Ambar Universal APS Plus; FGM

Intervention Type: DEVICE

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive

Experimental group 2

50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.

Group Type: EXPERIMENTAL

Dentin Overwet

Intervention Type: PROCEDURE

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on overwet dentin in the etch-and-rinse application strategy.

Prime&Bond Active; Dentsply Sirona

Intervention Type: DEVICE

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive

Control group 1

50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.

Group Type: ACTIVE_COMPARATOR

Dentin Wet

Intervention Type: PROCEDURE

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on wet dentin in the etch-and-rinse application strategy.

Ambar Universal APS Plus; FGM

Intervention Type: DEVICE

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive

Control group 2

50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.

Group Type: ACTIVE_COMPARATOR

Dentin Wet

Intervention Type: PROCEDURE

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on wet dentin in the etch-and-rinse application strategy.

Prime&Bond Active; Dentsply Sirona

Intervention Type: DEVICE

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive

Interventions

Dentin Wet

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on wet dentin in the etch-and-rinse application strategy.

Intervention Type: PROCEDURE

Dentin Overwet

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on overwet dentin in the etch-and-rinse application strategy.

Intervention Type: PROCEDURE

Ambar Universal APS Plus; FGM

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive

Intervention Type: DEVICE

Prime&Bond Active; Dentsply Sirona

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients older than 18 years.
• Presence of at least two Non-Carious Cervical Lesions in the dental arch with a need for restorative treatment.
• Acceptable level of oral hygiene according to the Simplified Oral Hygiene Index.
• At least 20 teeth in function.

Exclusion Criteria

• Driving difficulties that prevent adequate oral hygiene.
• Periodontal disease.
• Active caries lesions on the teeth included in the research.
• Parafunctional habits.
• Active staples of removable partial dentures on the teeth included in the research and that these are not pillars of prostheses.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Estadual de Ponta Grossa

OTHER

Sponsor Role: collaborator

Universidad de los Andes, Chile

OTHER

Sponsor Role: lead

Responsible Party

Mario Felipe Gutiérrez Reyes

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mario Gutierrez, PhD

Role: STUDY_DIRECTOR

Universidad de los Andes, Chile

Locations

Mario Felipe Gutiérrez Reyes

Santiago, Santiago Metropolitan, Chile

Countries

Chile

Other Identifiers

F142025

Identifier Type: -

Identifier Source: org_study_id