Effect of Increased Improve Time on Adhesive System

NCT03254706 | Completed DMC

• 1 other identifier: 57317816.6.0000.5084
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This double-blind randomized clinical trial evaluates the influence of increased application time of a new etch-and-rinse two-step adhesive Single Link; (Angelus Dental Products Industry) applied in non-carious cervical lesions (NCCLs). Methods: A total of 221 restorations were randomly placed in 35 patients assigned in four groups to two different etch-and-rinse two-step adhesive Peak® Universal Bond (P) (Ultradent Products Ind) and Single Link (SL) (Angelus Dental Products Industry). The adhesives systems were applied on the NCCLs follows: P1 - applied according to the manufacturer's; P2X - applied for the double time; SL1 and; SL2X. The resin composite Amelogen (Ultradent) was placed incrementally. The restorations were evaluated imediataly (baseline), 6 and 12 months, using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests (=0.05).

Conditions

Clinical Trial

Keywords

Dentin adhesive; Non-carious cervical lesions; Longevity.

Outcome Measures

Primary Outcomes (1)

• Retention/fracture

  The primary clinical endpoint was restoration retention/fracture

  6 months

Secondary Outcomes (4)

• Marginal staining

  6 months

• marginal adaptation

  6 months

• postoperative sensitivity

  6 months

• recurrence of caries.

  6 months

Study Arms (4)

Peak etch-and-rinse (P1)

ACTIVE COMPARATOR

Application Mode - According to the manufacturer's instructions.

Other: Peak etch-and-rinse (P1)

Peak applied for double time(P2X)

EXPERIMENTAL

Application Mode - According to the manufacturer's instructions, but for the double time.

Other: Peak applied for double time(P2X)

Single Link etch-and-rinse (SL1)

ACTIVE COMPARATOR

Application Mode - According to the manufacturer's instructions.

Other: Single Link etch-and-rinse (SL1)

Single Link double time (SL2X)

EXPERIMENTAL

Application Mode - According to the manufacturer's instructions, but for the double time.

Other: Single Link double time (SL2X)

Interventions

Peak etch-and-rinse (P1) OTHER

Application Mode - Peak Adhesive system applied according to the manufacturer's instructions.

Also known as: P1

Peak etch-and-rinse (P1)

Peak applied for double time(P2X) OTHER

Application Mode - Peak Adhesive system applied according to the manufacturer's instructions, but for the double time.

Also known as: P2X

Peak applied for double time(P2X)

Single Link etch-and-rinse (SL1) OTHER

Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions.

Also known as: SL1

Single Link etch-and-rinse (SL1)

Single Link double time (SL2X) OTHER

Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions, but for the double time.

Also known as: SL2X

Single Link double time (SL2X)

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, and 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, and 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

MeSH Terms

Interventions

1,2-dihydroxy-4-(nitroethenyl)benzene

Study Officials

• Márcio Camargo, Master

  Universidade Estadual do Oeste do Paraná

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A 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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: This was a double-blind, superiority, split-mouth randomized clinical trial. The study was carried out in the clinics of the School of Dentistry at the local University from August 2015 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)