BONDING TO ENAMEL USING A UNIVERSAL ADHESIVE

NCT03254693 | Completed Phase 4 DMC

• 1 other identifier: 56013116.0.0000.0107
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This double-blind randomized clinical trial evaluates strategies for improving the bonding of universal adhesive to enamel in non-carious cervical lesions (NCCL) of a new universal multi-mode adhesive (Ambar Universal; FGM). Methods: A total of 134 restorations were randomly placed in 19 patients according to the following groups: SE - Self-etch; SEE - Selective etching; SE2X - Self-etch doble time; SE1+ - Self-etch additional layer. The resin composite Opallis (FGM) was placed incrementally. The restorations were evaluated after one week (baseline), 6 and 12 months, using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests (=0.05).

Conditions

Clinical Trial

Keywords

Non-carious cervical lesions; Universal system; Longevity.

Outcome Measures

Primary Outcomes (1)

• Retention

  The primary clinical endpoint was restoration retention/fracture.

  6 montths

Secondary Outcomes (1)

• Marginal Adaptation

  6 months

Study Arms (4)

1-step self-etch approach (SE)

ACTIVE COMPARATOR

According to the manufacturer's instructions.

Combination Product: 1-step self-etch approach (SE)

selective enamel etching (SEE)

ACTIVE COMPARATOR

According to the manufacturer's instructions.

Combination Product: selective enamel etching (SEE)

1-step self-etch for double time (SE2X)

EXPERIMENTAL

According to the manufacturer's instructions, but for the double time (20 s) in the each application.

Other: 1-step self-etch for double time (SE2X)

1-step self-etch additional layer (SE1+)

EXPERIMENTAL

According to the manufacturer's instructions, but apply tree times.

Other: 1-step self-etch additional layer (SE1+)

Interventions

1-step self-etch approach (SE) COMBINATION_PRODUCT

Application mode - Do not use etchan. According to the manufacturer's instructions.

Also known as: SE

1-step self-etch approach (SE)

selective enamel etching (SEE) COMBINATION_PRODUCT

Application mode - Etch only on enamel for 15 s. Rinse for 15s. Air dry to remove excess water.According to the manufacturer's instructions.

Also known as: SEE

selective enamel etching (SEE)

1-step self-etch for double time (SE2X) OTHER

Application mode - Do not use etchan. According to the manufacturer's instructions, but for the double time (20 s) in the each application.

Also known as: SE2X

1-step self-etch for double time (SE2X)

1-step self-etch additional layer (SE1+) OTHER

Application mode - Do not use etchan. According to the manufacturer's instructions, but apply tree times.

Also known as: SE1+

1-step self-etch additional layer (SE1+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants had to be in good general health.
• At least 18 years old
• Have an acceptable oral hygiene level
• Present at least 20 teeth under occlusion
• At least four NCCLs in four different teeth
• These lesions had to be non-carious, non-retentive, deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility.
• The cavo-surface margin could not involve more than 50% of enamel, and all lesions had cervical margins ending in dentin.

You may not qualify if:

• Participants had not be in good general health.
• At less 18 years old
• Have not an acceptable oral hygiene level
• Present at less 20 teeth under occlusion
• At less four NCCLs in four different teeth, these lesions had not be non-carious, retentive and involve only enamel of vital teeth with mobility.

Sponsors & Collaborators

• Universidade Estadual de Ponta Grossa: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Universidade Estadual do Oeste do Paraná

Cascavel, Paraná, 85819-110, Brazil

Location

Study Officials

• Rafael Scheffer, Master

  Universidade Estadual do Oeste do Paraná

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: staff member not involved in the research protocol performed the randomization process with computer-generated tables. Details of the allocated groups were recorded on cards contained in sequentially numbered, opaque, sealed envelopes. Opening the envelope only on the day of the restorative procedure guaranteed the concealment of the random sequence. The examiners were not involved with the restoration procedures and therefore blinded to the group assignment, performed the clinical evaluation. Patient were also blinded to group assignment in a double-blind randomized clinical trial design.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: This was a double-blind, equivalence superiority, split-mouth randomized clinical trial. The restoration procedures were carried out within the clinics of the Dental School of the Federal University of Rio de Janeiro in Rio de Janeiro (Rio de Janeiro, Brazil) and at the State University Oeste do Paraná in Cascavel (Paraná, Brazil) from July 2016 to August 2017.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 18, 2017
• Study Start: February 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

BR (1)