Effect of Increased Improve Time on Adhesive System (RCT)

Effect of Increased Improve Time on Adhesive System: A RANDOMIZED CLINICAL TRIAL

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).

Study Overview

• Status: Completed
• Conditions: Clinical Trial
• Intervention / Treatment: Other: Peak etch-and-rinse (P1); Other: Peak applied for double time(P2X); Other: Single Link etch-and-rinse (SL1); Other: Single Link double time (SL2X)

Detailed Description

Methods:

Recruitment Patients were recruited as they seek for treatment in the clinics of Dentistry of the local university. No advertisement was made for participant recruitment. Patients were recruited in the order in which they reported for the screening session, thus forming a sample of convenience.

Eligibility criteria A total of 183 participants were examined by two calibrated dental students to check if they met the inclusion and exclusion criteria.

Sample size calculation The annual retention rate to one-step self-etch adhesives in NCCLs was reported to be 4.4% in a recent systematic review. Considering that this decline follow a linear trend, the overall retention rate of one-step self-etch adhesives will be approximately 78% after 5-year of clinical service. With an of 0.05, a power of 80%, and a two-sided test, the minimal sample size will be 41 restorations in each group in order to detect a difference of equivalence of 15% among the test groups.

Interventions 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).

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • PR
    • Cascavel, PR, Brazil, 85819-110
      • Universidade Estadual do Oeste do Paraná

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peak etch-and-rinse (P1); Application Mode - According to the manufacturer's instructions.	Other: Peak etch-and-rinse (P1); Application Mode - Peak Adhesive system applied according to the manufacturer's instructions.; Other Names: P1
Experimental: Peak applied for double time(P2X); Application Mode - According to the manufacturer's instructions, but for the double time.	Other: Peak applied for double time(P2X); Application Mode - Peak Adhesive system applied according to the manufacturer's instructions, but for the double time.; Other Names: P2X
Active Comparator: Single Link etch-and-rinse (SL1); Application Mode - According to the manufacturer's instructions.	Other: Single Link etch-and-rinse (SL1); Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions.; Other Names: SL1
Experimental: Single Link double time (SL2X); Application Mode - According to the manufacturer's instructions, but for the double time.	Other: Single Link double time (SL2X); Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions, but for the double time.; Other Names: SL2X

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention/fracture	The primary clinical endpoint was restoration retention/fracture	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal staining	restoration Marginal staining	6 months
marginal adaptation	restoration marginal adaptation	6 months
postoperative sensitivity	restoration postoperative sensitivity	6 months
recurrence of caries.	restauration recurrence of caries	6 months

Collaborators and Investigators

• Sponsor: Universidade Estadual de Ponta Grossa
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Investigators: Study Chair: Márcio Camargo, Master, Universidade Estadual do Oeste do Paraná

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 27, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Dentin adhesive; Non-carious cervical lesions; Longevity.
• Other Study ID Numbers: 57317816.6.0000.5084

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No