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

NCT07034235 | Completed DMC

• 1 other identifier: F142025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-carious Cervical Lesions

Keywords

Dental bonding; Tooth erosion; Tooth Wear; Adhesive systems; Dentinal moisture

Outcome Measures

Primary Outcomes (1)

• Retention of restorations

  Retention measured by World Dental Federation (FDI) criteria as following: * VG: Clinically very good - Restoration retained, no fractures / cracks; * G: Clinically good - Small hairline crack; * SS: Clinically sufficient/satisfactory - Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity); * US: Clinically unsatisfactory - Chipping fractures which damage marginal quality; bulk fractures with or without partial loss (less than half of the restoration); * PO: Clinically poor - (Partial or complete) loss of restoration, (replacement necessary).

  From date of randomization until thirty-six four months

Secondary Outcomes (2)

• Marginal Adaptation of restorations

  From date of randomization until thirty six months

• Marginal Staining of restorations

  From date of randomization until thirty six months

Study Arms (4)

Experimental group 1

EXPERIMENTAL

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

Procedure: Dentin Overwet; Device: Ambar Universal APS Plus; FGM

Experimental group 2

EXPERIMENTAL

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

Procedure: Dentin Overwet; Device: Prime&Bond Active; Dentsply Sirona

Control group 1

ACTIVE COMPARATOR

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

Procedure: Dentin Wet; Device: Ambar Universal APS Plus; FGM

Control group 2

ACTIVE COMPARATOR

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

Procedure: Dentin Wet; Device: Prime&Bond Active; Dentsply Sirona

Interventions

Dentin Wet 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.

Control group 1; Control group 2

Dentin Overwet 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.

Experimental group 1; Experimental group 2

Ambar Universal APS Plus; FGM DEVICE

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

Control group 1; Experimental group 1

Prime&Bond Active; Dentsply Sirona DEVICE

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

Control group 2; Experimental group 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Universidade Estadual de Ponta Grossa: collaborator

Study Sites (1)

Mario Felipe Gutiérrez Reyes

Santiago, Santiago Metropolitan, 8360053, Chile

Location

MeSH Terms

Conditions

Tooth Erosion; Tooth Wear

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mario Gutierrez, PhD

  Universidad de los Andes, Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Two blinded, experienced, and calibrated dentists (who specialized in esthetic dentistry with more than 15 years of clinical practice), will perform the clinical evaluation. Patients will be also blinded to group assignment. An inter-examiner and inter-examiner agreement of at least 85% will be necessary before beginning the evaluation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: January 6, 2025
• Primary Completion: March 3, 2025
• Study Completion: March 10, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)