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

NCT06465849 | Completed DMC

• 1 other identifier: CEC2024055
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Non-carious Cervical Lesions

Keywords

Dental bonding; Tooth erosion; Tooth Wear; Adhesive systems; Etching Time

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 twenty four months

Secondary Outcomes (2)

• Marginal Adaptation of restorations

  From date of randomization until twenty four months

• Marginal Staining of restorations

  From date of randomization until twenty four months

Study Arms (4)

Experimental group 1

EXPERIMENTAL

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

Procedure: Dentin Etching time for 5 seconds; Device: Scotchbond Universal Plus; 3M

Experimental group 2

EXPERIMENTAL

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

Procedure: Dentin Etching time for 5 seconds; Device: Gluma Universal Bond; Kulzer

Control group 1

ACTIVE COMPARATOR

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

Device: Scotchbond Universal Plus; 3M; Procedure: Dentin Etching time for 15 seconds

Control group 2

ACTIVE COMPARATOR

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

Device: Gluma Universal Bond; Kulzer; Procedure: Dentin Etching time for 15 seconds

Interventions

Dentin Etching time for 5 seconds PROCEDURE

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on dentin etched for 5 seconds in the etch-and-rinse application strategy.

Experimental group 1; Experimental group 2

Scotchbond Universal Plus; 3M DEVICE

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive (Scotchbond Universal Plus; 3M).

Control group 1; Experimental group 1

Gluma Universal Bond; Kulzer DEVICE

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive (Gluma Universal Bond; Kulzer).

Control group 2; Experimental group 2

Dentin Etching time for 15 seconds PROCEDURE

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on dentin etched for 15 seconds in the etch-and-rinse application strategy.

Control group 1; Control 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.
• Non-Carious Cervical Lesions with a maximum of 50% of enamel margin.

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
• Agencia Nacional de Investigación y Desarrollo: 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 Felipe Gutiérrez Reyes, 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. Experimental group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (3M) on dentin etched for 5 seconds. Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Kulzer) on dentin etched for 5 seconds. Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (3M) on dentin etched for 15 seconds. Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Kulzer) on dentin etched for 15 seconds. LCNCs will be randomized to universal adhesive usage and etching time.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: March 30, 2024
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

CL (1)