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Completed

NCT Number: NCT03254706

Effect of Increased Improve Time on Adhesive System

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Estadual do Oeste do Paraná

Cascavel, Paraná, 85819-110, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peak etch-and-rinse (P1)

Other

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

Other names: 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.

Other names: P2X

Single Link etch-and-rinse (SL1)

Other

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

Other names: 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.

Other names: SL2X

Primary outcomes

  1. Retention/fracture

    Time frame: 6 months

    The primary clinical endpoint was restoration retention/fracture

Secondary outcomes

  1. Marginal staining

    Time frame: 6 months

    restoration Marginal staining

  2. marginal adaptation

    Time frame: 6 months

    restoration marginal adaptation

  3. postoperative sensitivity

    Time frame: 6 months

    restoration postoperative sensitivity

  4. recurrence of caries.

    Time frame: 6 months

    restauration recurrence of caries

Sponsors and collaborators

Lead sponsor

Universidade Estadual de Ponta Grossa

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2017
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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