NCT05945173

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2023

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

June 12, 2023

Last Update Submit

July 11, 2023

Conditions

Non-carious Cervical Lesions

Keywords

Dental bondingTooth erosionTooth wearAdhesive systemsSolvent

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 selective enamel etching strategy.

Procedure: Evaporation time for 25 secondsDevice: alcohol/water-based universal adhesive

Experimental group 2

EXPERIMENTAL

35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.

Procedure: Evaporation time for 25 secondsDevice: acetone-based universal adhesive

Control group 1

ACTIVE COMPARATOR

35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.

Procedure: Evaporation time for 5 secondsDevice: alcohol/water-based universal adhesive

Control group 2

ACTIVE COMPARATOR

35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.

Procedure: Evaporation time for 5 secondsDevice: acetone-based universal adhesive

Interventions

Evaporation time for 5 secondsPROCEDURE

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive with solvent evaporation for 5 seconds.

Also known as: Evaporation time of solvent for 5 seconds
Control group 1Control group 2
Evaporation time for 25 secondsPROCEDURE

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive with solvent evaporation for 25 seconds.

Also known as: Evaporation time of solvent for 25 seconds
Experimental group 1Experimental group 2
alcohol/water-based universal adhesiveDEVICE

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

Also known as: alcohol/water-based adhesive
Control group 1Experimental group 1
acetone-based universal adhesiveDEVICE

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

Also known as: acetone universal adhesive
Control group 2Experimental group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mario Felipe Gutiérrez Reyes

Santiago, Santiago Metropolitan, 7620086, Chile

Location

MeSH Terms

Conditions

Tooth ErosionTooth Wear

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic 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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, 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
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 12, 2023

First Posted

July 14, 2023

Study Start

March 30, 2023

Primary Completion

June 23, 2023

Study Completion

June 23, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations

CL(1)