Effect of Increased Improve Time on Adhesive System

Clinical Trial Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254706
• Other study ID #: 57317816.6.0000.5084
• Status: Completed
• Phase: N/A
• First received: August 15, 2017
• Last updated: August 27, 2017
• Start date: February 1, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2017
• Source: Universidade Estadual de Ponta Grossa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Trial

Intervention

Other:
• Peak etch-and-rinse (P1)
Application Mode - Peak Adhesive system applied according to the manufacturer's instructions.
• Peak applied for double time(P2X)
Application Mode - Peak Adhesive system applied according to the manufacturer's instructions, but for the double time.
• Single Link etch-and-rinse (SL1)
Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions.
• Single Link double time (SL2X)
Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions, but for the double time.

Locations

Country	Name	City	State
Brazil	Universidade Estadual do Oeste do Paraná	Cascavel	PR

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual de Ponta Grossa	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention/fracture	The primary clinical endpoint was restoration retention/fracture	6 months
Secondary	Marginal staining	restoration Marginal staining	6 months
Secondary	marginal adaptation	restoration marginal adaptation	6 months
Secondary	postoperative sensitivity	restoration postoperative sensitivity	6 months
Secondary	recurrence of caries.	restauration recurrence of caries	6 months