Clinical TrialRCTNCT03254706
Effect of Increased Improve Time on Adhesive System
A study testing Peak etch-and-rinse (P1), Peak applied for double time(P2X) and Single Link etch-and-rinse (SL1) in people with Clinical Trial, run by Universidade Estadual de Ponta Grossa at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Trial
- What is being tested?
- Peak etch-and-rinse (P1), Peak applied for double time(P2X) and Single Link etch-and-rinse (SL1)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2016to 1 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual do Oeste do Paraná
Cascavel, Paraná, 85819-110
About this study
Official title: 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).
Read the 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).
- Conditions
- Clinical Trial
- Being tested
- Peak etch-and-rinse (P1), Peak applied for double time(P2X), Single Link etch-and-rinse (SL1), Single Link double time (SL2X)
- Keywords
- Dentin adhesive; Non-carious cervical lesions; Longevity.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peak etch-and-rinse (P1)Other
Also called P1
Application Mode - Peak Adhesive system applied according to the manufacturer's instructions.
Peak applied for double time(P2X)Other
Also called P2X
Application Mode - Peak Adhesive system applied according to the manufacturer's instructions, but for the double time.
Single Link etch-and-rinse (SL1)Other
Also called SL1
Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions.
Single Link double time (SL2X)Other
Also called SL2X
Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions, but for the double time.
| Study group | Role | What they receive |
|---|---|---|
| Peak etch-and-rinse (P1) | Active comparator | Application Mode - According to the manufacturer's instructions. Receives: 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. Receives: Other: Peak applied for double time(P2X) |
| Single Link etch-and-rinse (SL1) | Active comparator | Application Mode - According to the manufacturer's instructions. Receives: 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. Receives: Other: Single Link double time (SL2X) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention/fracture
The primary clinical endpoint was restoration retention/fracture
Measured: 6 months
Secondary outcomes (4)
Marginal staining
restoration Marginal staining
Measured: 6 months
marginal adaptation
restoration marginal adaptation
Measured: 6 months
postoperative sensitivity
restoration postoperative sensitivity
Measured: 6 months
recurrence of caries.
restauration recurrence of caries
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start1 Feb 2016
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Ponta Grossa
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Eloisa Andrade de Paula, Universidade Estadual do Oeste do Paraná
- Investigators
- Márcio Camargo, Master, Study chair, Universidade Estadual do Oeste do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254706
- Sponsor's protocol ID
- 57317816.6.0000.5084
- Acronym
- RCT
- Status last verified
- Aug 2017
- First submitted
- 15 Aug 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increased Improve Time on Adhesive System: A RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT03254706
- Acronym / sponsor ID
- RCT / 57317816.6.0000.5084
- Conditions
- Clinical Trial
- Keywords
- Dentin adhesive; Non-carious cervical lesions; Longevity.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidade Estadual de Ponta GrossaUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Peak etch-and-rinse (P1) | Active comparator | Other: Peak etch-and-rinse (P1)Application Mode - According to the manufacturer's instructions. |
| Peak applied for double time(P2X) | Experimental | Other: Peak applied for double time(P2X)Application Mode - According to the manufacturer's instructions, but for the double time. |
| Single Link etch-and-rinse (SL1) | Active comparator | Other: Single Link etch-and-rinse (SL1)Application Mode - According to the manufacturer's instructions. |
| Single Link double time (SL2X) | Experimental | Other: Single Link double time (SL2X)Application Mode - According to the manufacturer's instructions, but for the double time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peak etch-and-rinse (P1)Also: P1Application Mode - Peak Adhesive system applied according to the manufacturer's instructions. | Other | Peak etch-and-rinse (P1) |
| Peak applied for double time(P2X)Also: P2XApplication Mode - Peak Adhesive system applied according to the manufacturer's instructions, but for the double time. | Other | Peak applied for double time(P2X) |
| Single Link etch-and-rinse (SL1)Also: SL1Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions. | Other | Single Link etch-and-rinse (SL1) |
| Single Link double time (SL2X)Also: SL2XApplication Mode - Single Link Adhesive system applied according to the manufacturer's instructions, but for the double time. | Other | Single Link double time (SL2X) |
Primary outcome
Retention/fracture
Time frame: 6 months
The primary clinical endpoint was restoration retention/fracture
4 secondary outcomes
Marginal staining
Time frame: 6 months
marginal adaptation
Time frame: 6 months
postoperative sensitivity
Time frame: 6 months
recurrence of caries.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Márcio Camargo, Master study chair
Universidade Estadual do Oeste do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peak etch-and-rinse (P1), Peak applied for double time(P2X) and Single Link etch-and-rinse (SL1) in people with Clinical Trial, run by Universidade Estadual de Ponta Grossa at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention/fracture (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.