Clinical trial NCT05945173: Evaluation of the Solvent Evaporation Time of Universal Adhesives in the Quality of Cervical Lesions Restorations
Official title: Clinical Evaluation of the Effect of the Prolonged Evaporation Time of the Solvent of Two Universal Adhesives in Restorations of Non-carious Cervical Lesions: Double-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-carious Cervical Lesions
Keywords: Dental bonding
Tooth erosion
Tooth wear
Adhesive systems
Solvent
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
Collaborators: name: Agencia Nacional de Investigación y Desarrollo
First posted: 2023-07-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a four-arm, double-blind, randomized controlled clinical trial. Experimental group 1: 35 non-carious cervical lesions (NCCL) using an alcohol- and water-based solvent universal adhesive with evaporation of solvent for 25 seconds. Experimental group 2: 35 NCCL using an acetone-based universal solvent adhesive with solvent evaporation for 25 seconds. Control group 1: 35 NCCL using an alcohol- and water-based universal solvent adhesive with evaporation of solvent for 5 seconds. Control group 2: 35 NCCL using an acetone-based universal solvent adhesive with solvent evaporation for 5 seconds. LCNCs will be randomized to universal adhesive usage and evaporation time.
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to evaluate the effect of prolonging solvent evaporation time on the 6- and 12-months clinical performance of two universal adhesive systems used as selective enamel etch (SEE).

Methods: 140 restorations will be randomly placed in 35 subjects according to the following groups: SUP5 (Scotchbond Universal Plus evaporated for 5 s); SUP25 (Scotchbond Universal Plus evaporated for 25 s); GBU5 (Gluma Bond Universal evaporated for 5 s); GBU25 (Gluma Bond Universal evaporated for 25 s). Resin composite will be placed incrementally and light-cured. The restorations will be evaluated at baseline, after a week, 6 and 12 months using the FDI and USPHS criteria. Statistical analyses will be performed using appropriate tests (α = 0.05).

Detailed 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 alcohol- and water-based solvent universal adhesive (Scotchbond Universal Plus; 3M) in the selective enamel etching strategy with evaporation of solvent for 25 seconds. Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an acetone-based universal solvent adhesive (Gluma Universal Bond; Kulzer) in the selective enamel etching strategy with solvent evaporation for 25 seconds. Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations, using an alcohol- and water-based universal solvent adhesive (Scotchbond Universal Plus; 3M), in the selective enamel etching strategy, with evaporation of solvent for 5 seconds. Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations, using an acetone-based universal solvent adhesive (Gluma Universal Bond; Kulzer), in the strategy of selective enamel etching, with solvent evaporation for 5 seconds. LCNCs will be randomized to universal adhesive usage and flash-off time. All groups will be light-cured with a light-curing device (SmartLite Focus, Dentsply) with a light intensity of 855 mW/cm² for 20 seconds. Operators will restore the cervical area by applying three increments of resin (Opallis, FGM Prod. Odont.Ltda, Joinville, SC, Brazil). Each increment will light cure for 10 s at 1200 mW/cm2 (Radii Cal, SDI, Victoria, Australia). Restorations will be finished immediately with fine diamond burs (#3195F and #3195FF, KG Sorensen, Barueri, SP, Brazil) and polished with discs and polishing gums (Soflex, 3 M ESPE, St. Paul, MN, EE. UU.).

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.
* 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.

Primary outcomes:
measure: Retention of restorations
timeFrame: From date of randomization until twenty four months
Secondary outcomes:
measure: Marginal Adaptation of restorations
timeFrame: From date of randomization until twenty four months
measure: Marginal Staining of restorations
timeFrame: From date of randomization until twenty four months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Mario Felipe Gutiérrez Reyes
state: Región Metropolitana
Study officials:
affiliation: Universidad de los Andes, Chile
name: Mario Felipe Gutiérrez Reyes, PhD
role: STUDY_DIRECTOR
References: