Evaluation of the Reduced Dentin Etching Time Using Universal Adhesives in the Quality of Cervical Lesions Restorations

Universidad de los Andes, Chile

Status: Completed

Conditions: Non-carious Cervical Lesions

Treatments: Device: Gluma Universal Bond; Kulzer; Procedure: Dentin Etching time for 5 seconds; Device: Scotchbond Universal Plus; 3M; Procedure: Dentin Etching time for 15 seconds

Study type: Interventional

Funder types: Other

Identifiers

NCT06465849

CEC2024055

Details and patient eligibility

About

The aim of this study will be to evaluate the effect of reduced dentin etching time on the 6- and 12-months clinical performance of two universal adhesive systems used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs).

Materials & Methods: 140 restorations will be randomly placed in 35 subjects according to the following groups: SUP5 (Scotchbond Universal Plus adhesive on dentin etched for 5 seconds); SUP15 (Scotchbond Universal Plus adhesive on dentin etched for 15 seconds); GBU5 (Gluma Universal Bond adhesive on dentin etched for 5 seconds); GBU15 (Gluma Universal Bond adhesive on dentin etched for 15 seconds). 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 will be light cured for 20s/1,000 mW/cm2. The restorations will be finished immediately with fine diamond burs and polishers. The restorations will be evaluated at baseline and after 6- and 12-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. Experimental group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Scotchbond Universal Plus; 3M) on dentin etched for 5 seconds in the etch-and-rinse application strategy.

Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Gluma Universal Bond; Kulzer) on dentin etched for 5 seconds in the etch-and-rinse application strategy.

Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Scotchbond Universal Plus; 3M) on dentin etched for 15 seconds in the etch-and-rinse application strategy.

Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Gluma Universal Bond; Kulzer) on dentin etched for 15 seconds in the etch-and-rinse application strategy.

LCNCs will be randomized to universal adhesive usage and dentin etching time. All groups will be light-cured with a lightcuring device (SmartLite Focus, Dentsply) with a light intensity of 900 mW/cm² for 10 seconds. Operators will restore the cervical area by applying three increments of resin (Vittra APS, FGM Prod. Odont.Ltda, Joinville, SC, Brazil). Each increment will light cure for 20 s at 900 mW/cm2 (SmartLite Focus, Dentsply). Restorations will be finished immediately with fine and extra fine diamond burs and polished with polishing gums.

Enrollment: 35 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.
• Non-Carious Cervical Lesions with a maximum of 50% of enamel margin.

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

---

35 participants in 4 patient groups

Experimental group 1

Experimental group

Description:

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

Treatment:

Device: Scotchbond Universal Plus; 3M

Procedure: Dentin Etching time for 5 seconds

Experimental group 2

Experimental group

Description:

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

Treatment:

Procedure: Dentin Etching time for 5 seconds

Device: Gluma Universal Bond; Kulzer

Control group 1

Active Comparator group

Description:

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

Treatment:

Procedure: Dentin Etching time for 15 seconds

Device: Scotchbond Universal Plus; 3M

Control group 2

Active Comparator group

Description:

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

Treatment:

Procedure: Dentin Etching time for 15 seconds

Device: Gluma Universal Bond; Kulzer