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

Universidad de los Andes, Chile

Status: Completed

Conditions: Non-carious Cervical Lesions

Treatments: Device: Ambar Universal APS Plus; FGM; Procedure: Dentin Overwet; Procedure: Dentin Wet; Device: Prime&Bond Active; Dentsply Sirona

Study type: Interventional

Funder types: Other

Identifiers

NCT07034235

F142025

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 4 patient groups

Experimental group 1

Experimental group

Description:

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

Treatment:

Procedure: Dentin Overwet

Device: Ambar Universal APS Plus; FGM

Experimental group 2

Experimental group

Description:

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

Treatment:

Device: Prime&Bond Active; Dentsply Sirona

Procedure: Dentin Overwet

Control group 1

Active Comparator group

Description:

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

Treatment:

Procedure: Dentin Wet

Device: Ambar Universal APS Plus; FGM

Control group 2

Active Comparator group

Description:

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

Treatment:

Device: Prime&Bond Active; Dentsply Sirona

Procedure: Dentin Wet