Evaluation of Double Layer Application Using a Universal Adhesive in the Quality of Cervical Lesions Restorations

NCT06474494 | Completed DMC

• 1 other identifier: CEC2024050
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study will be to evaluate the effect of a double layer application of a universal adhesive system used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs), on the 6- and 12-months clinical performance. Materials \& Methods: 144 restorations were randomly placed in 36 subjects (16 male and 20 female) according to the following groups (n=36): ER1 (one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode); ER2 (double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode); SEE1 (one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching); SEE2 (double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching). All groups were light-cured for 10s/1,000 mW/cm2 only after final layer. 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; Double layer

Outcome Measures

Primary Outcomes (1)

• Retention rate of restorations

  Retention rate measured by World Dental Federation (FDI) criteria as following: * 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 rate of restorations

  From date of randomization until twenty four months

• Marginal Staining rate of restorations

  From date of randomization until twenty four months]

Study Arms (4)

Experimental: Experimental group 1

EXPERIMENTAL

35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode

Procedure: Application of double layer; Procedure: Etch-and-rinse application mode

Experimental group 2

EXPERIMENTAL

35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode

Procedure: Application of double layer; Procedure: Selective enamel etching application mode

Control group 1

ACTIVE COMPARATOR

35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode

Procedure: Application of one layer; Procedure: Etch-and-rinse application mode

Control group 2

ACTIVE COMPARATOR

35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode

Procedure: Application of one layer; Procedure: Selective enamel etching application mode

Interventions

Application of one layer PROCEDURE

35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive

Control group 1; Control group 2

Application of double layer PROCEDURE

35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive

Experimental group 2; Experimental: Experimental group 1

Etch-and-rinse application mode PROCEDURE

35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as etch-and-rinse application mode

Control group 1; Experimental: Experimental group 1

Selective enamel etching application mode PROCEDURE

35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as selective enamel etching mode

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.
• 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 Gutierrez Reyes

  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 applying a double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode. Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode. Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode. Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode. LCNCs will be randomized to application mode and number of layers

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

CL (1)