Clinical TrialPhase 4RCTNCT03254693
BONDING TO ENAMEL USING A UNIVERSAL ADHESIVE
A Phase 4 study testing 1-step self-etch approach (SE), selective enamel etching (SEE) and 1-step self-etch for double time (SE2X) 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 strategies for improving the bonding of universal adhesive to enamel in non-carious cervical lesions (NCCL) of a new universal multi-mode adhesive (Ambar Universal; FGM). 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?
- 1-step self-etch approach (SE), selective enamel etching (SEE) and 1-step self-etch for double time (SE2X)
- 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
- Phase 4
- 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
- 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
- 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: STRATEGIES FOR BONDING TO ENAMEL USING A UNIVERSAL ADHESIVE ON SELF-ETCHING MODE
Objective: This double-blind randomized clinical trial evaluates strategies for improving the bonding of universal adhesive to enamel in non-carious cervical lesions (NCCL) of a new universal multi-mode adhesive (Ambar Universal; FGM).
Methods: A total of 134 restorations were randomly placed in 19 patients according to the following groups: SE - Self-etch; SEE - Selective etching; SE2X - Self-etch doble time; SE1+ - Self-etch additional layer. The resin composite Opallis (FGM) was placed incrementally. The restorations were evaluated after one week (baseline), 6 and 12 months, using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests (=0.05).
Read the detailed description
Interventions: restorative procedure All the patients selected for this study received dental prophylaxis with a suspension of pumice and water in a rubber cup and signed an informed consent form two weeks before the restorative procedures.
The degree of sclerotic dentin from the NCCLs was measured according to the criteria described by Swift and others. The cavity dimensions in millimeters (height, width, and depth), the geometry of the cavity (evaluated by profile photograph and labeled at <45o, 45o-90o, 90o<135o, and >135o), the presence of an antagonist, and the presence of attrition facets were observed and recorded. Pre-operative sensitivity was also evaluated by applying air for 10 s from a dental syringe placed 2 cm from the tooth surface and with an explorer. These features were recorded to allow comparison of the baseline features of the dentin cavities among experimental groups.
To calibrate the restorative procedure, the study director placed one restoration of each group to identify all steps involved in the application technique. Then, the two operators, who were resident dentists with more than five years of clinical experience in operative dentistry, placed four restorations, one of each group, under the supervision of the study director in a clinical setting. The restoration failures were shown to the operators prior to starting the study. At this point, the operators were considered calibrated to perform the restorative procedures.
The operators restored all teeth. All participants received four restorations, one of each experimental group in different lesions previously selected according to the inclusion criteria.
Before restorative procedures, the operators anesthetized the teeth with a 3% mepivacaine solution (Mepisv, Nova DFL, Rio de Janeiro, RJ, Brazil) and cleaned all lesions with pumice and water in a rubber cup, followed by rinsing and drying. Then, shade selection was made using a shade guide.
Cleaning of all lesions with pumice and water in a rubber cup was carried out, followed by rinsing and drying. Using a shade-selection guide, the proper shade of the composite was determined. Following the ADA guidelines, the operators did not prepare any additional retention or bevel.
The NCCLs received the multimode adhesive system applied in different modes: 1-step self-etch approach (SE), selective enamel etching (SEE), 1-step self-etch applied for double time in the enamel (SE2X), 1-step self-etch approach with additional layer (SE1+) was applied as described below. The compositions, more details regarding the adhesion strategies used and batch numbers are described in Table 2.
The adhesives were light-cured with a LED light-curing unit (1,000 mW/cm2) (Radii-cal), according to the manufacturer's instructions (Table 2). Opallis (FGM) composite resin was used in 2 to 3 increments, each one being light-cured (Radii-cal) for 30 s. The restorations were finished immediately with fine #2200 diamond burs (KG Sorensen). Polishing was performed with rubber points (Astropol, Ivoclar Vivadent, Liechtenstein).
- Conditions
- Clinical Trial
- Being tested
- 1-step self-etch approach (SE), selective enamel etching (SEE), 1-step self-etch for double time (SE2X), 1-step self-etch additional layer (SE1+)
- Keywords
- Non-carious cervical lesions; Universal system; Longevity.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-step self-etch approach (SE)Combination product
Also called SE
Application mode - Do not use etchan. According to the manufacturer's instructions.
selective enamel etching (SEE)Combination product
Also called SEE
Application mode - Etch only on enamel for 15 s. Rinse for 15s. Air dry to remove excess water.According to the manufacturer's instructions.
1-step self-etch for double time (SE2X)Other
Also called SE2X
Application mode - Do not use etchan. According to the manufacturer's instructions, but for the double time (20 s) in the each application.
1-step self-etch additional layer (SE1+)Other
Also called SE1+
Application mode - Do not use etchan. According to the manufacturer's instructions, but apply tree times.
| Study group | Role | What they receive |
|---|---|---|
| 1-step self-etch approach (SE) | Active comparator | According to the manufacturer's instructions. Receives: Combination Product: 1-step self-etch approach (SE) |
| selective enamel etching (SEE) | Active comparator | According to the manufacturer's instructions. Receives: Combination Product: selective enamel etching (SEE) |
| 1-step self-etch for double time (SE2X) | Experimental | According to the manufacturer's instructions, but for the double time (20 s) in the each application. Receives: Other: 1-step self-etch for double time (SE2X) |
| 1-step self-etch additional layer (SE1+) | Experimental | According to the manufacturer's instructions, but apply tree times. Receives: Other: 1-step self-etch additional layer (SE1+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
The primary clinical endpoint was restoration retention/fracture.
Measured: 6 montths
Secondary outcomes (1)
Marginal Adaptation
Restoration marginal adaptation.
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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This was a double-blind, equivalence superiority, split-mouth randomized clinical trial. The restoration procedures were carried out within the clinics of the Dental School of the Federal University of Rio de Janeiro in Rio de Janeiro (Rio de Janeiro, Brazil) and at the State University Oeste do Paraná in Cascavel (Paraná, Brazil) from July 2016 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
- Rafael Scheffer, Master, Study chair, Universidade Estadual do Oeste do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254693
- Sponsor's protocol ID
- 56013116.0.0000.0107
- 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
- STRATEGIES FOR BONDING TO ENAMEL USING A UNIVERSAL ADHESIVE ON SELF-ETCHING MODE
- ClinicalTrials.gov ID
- NCT03254693
- Acronym / sponsor ID
- RCT / 56013116.0.0000.0107
- Conditions
- Clinical Trial
- Keywords
- Non-carious cervical lesions; Universal system; Longevity.
- Phase
- Phase 4
- 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 strategies for improving the bonding of universal adhesive to enamel in non-carious cervical lesions (NCCL) of a new universal multi-mode adhesive (Ambar Universal; FGM).
Methods: A total of 134 restorations were randomly placed in 19 patients according to the following groups: SE - Self-etch; SEE - Selective etching; SE2X - Self-etch doble time; SE1+ - Self-etch additional layer. The resin composite Opallis (FGM) was placed incrementally. The restorations were evaluated after one week (baseline), 6 and 12 months, using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests (=0.05).
Detailed description
Interventions: restorative procedure All the patients selected for this study received dental prophylaxis with a suspension of pumice and water in a rubber cup and signed an informed consent form two weeks before the restorative procedures.
The degree of sclerotic dentin from the NCCLs was measured according to the criteria described by Swift and others. The cavity dimensions in millimeters (height, width, and depth), the geometry of the cavity (evaluated by profile photograph and labeled at <45o, 45o-90o, 90o<135o, and >135o), the presence of an antagonist, and the presence of attrition facets were observed and recorded. Pre-operative sensitivity was also evaluated by applying air for 10 s from a dental syringe placed 2 cm from the tooth surface and with an explorer. These features were recorded to allow comparison of the baseline features of the dentin cavities among experimental groups.
To calibrate the restorative procedure, the study director placed one restoration of each group to identify all steps involved in the application technique. Then, the two operators, who were resident dentists with more than five years of clinical experience in operative dentistry, placed four restorations, one of each group, under the supervision of the study director in a clinical setting. The restoration failures were shown to the operators prior to starting the study. At this point, the operators were considered calibrated to perform the restorative procedures.
The operators restored all teeth. All participants received four restorations, one of each experimental group in different lesions previously selected according to the inclusion criteria.
Before restorative procedures, the operators anesthetized the teeth with a 3% mepivacaine solution (Mepisv, Nova DFL, Rio de Janeiro, RJ, Brazil) and cleaned all lesions with pumice and water in a rubber cup, followed by rinsing and drying. Then, shade selection was made using a shade guide.
Cleaning of all lesions with pumice and water in a rubber cup was carried out, followed by rinsing and drying. Using a shade-selection guide, the proper shade of the composite was determined. Following the ADA guidelines, the operators did not prepare any additional retention or bevel.
The NCCLs received the multimode adhesive system applied in different modes: 1-step self-etch approach (SE), selective enamel etching (SEE), 1-step self-etch applied for double time in the enamel (SE2X), 1-step self-etch approach with additional layer (SE1+) was applied as described below. The compositions, more details regarding the adhesion strategies used and batch numbers are described in Table 2.
The adhesives were light-cured with a LED light-curing unit (1,000 mW/cm2) (Radii-cal), according to the manufacturer's instructions (Table 2). Opallis (FGM) composite resin was used in 2 to 3 increments, each one being light-cured (Radii-cal) for 30 s. The restorations were finished immediately with fine #2200 diamond burs (KG Sorensen). Polishing was performed with rubber points (Astropol, Ivoclar Vivadent, Liechtenstein).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- This was a double-blind, equivalence superiority, split-mouth randomized clinical trial. The restoration procedures were carried out within the clinics of the Dental School of the Federal University of Rio de Janeiro in Rio de Janeiro (Rio de Janeiro, Brazil) and at the State University Oeste do Paraná in Cascavel (Paraná, Brazil) from July 2016 to August 2017.
| Arm | Type | Receives |
|---|---|---|
| 1-step self-etch approach (SE) | Active comparator | Combination Product: 1-step self-etch approach (SE)According to the manufacturer's instructions. |
| selective enamel etching (SEE) | Active comparator | Combination Product: selective enamel etching (SEE)According to the manufacturer's instructions. |
| 1-step self-etch for double time (SE2X) | Experimental | Other: 1-step self-etch for double time (SE2X)According to the manufacturer's instructions, but for the double time (20 s) in the each application. |
| 1-step self-etch additional layer (SE1+) | Experimental | Other: 1-step self-etch additional layer (SE1+)According to the manufacturer's instructions, but apply tree times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants had to be in good general health.
- At least 18 years old
- Have an acceptable oral hygiene level
- Present at least 20 teeth under occlusion
- At least four NCCLs in four different teeth
Key exclusion criteria (5 listed)
- Participants had not be in good general health.
- At less 18 years old
- Have not an acceptable oral hygiene level
- 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 |
|---|---|---|
| 1-step self-etch approach (SE)Also: SEApplication mode - Do not use etchan. According to the manufacturer's instructions. | Combination product | 1-step self-etch approach (SE) |
| selective enamel etching (SEE)Also: SEEApplication mode - Etch only on enamel for 15 s. Rinse for 15s. Air dry to remove excess water.According to the manufacturer's instructions. | Combination product | selective enamel etching (SEE) |
| 1-step self-etch for double time (SE2X)Also: SE2XApplication mode - Do not use etchan. According to the manufacturer's instructions, but for the double time (20 s) in the each application. | Other | 1-step self-etch for double time (SE2X) |
| 1-step self-etch additional layer (SE1+)Also: SE1+Application mode - Do not use etchan. According to the manufacturer's instructions, but apply tree times. | Other | 1-step self-etch additional layer (SE1+) |
Primary outcome
Retention
Time frame: 6 montths
The primary clinical endpoint was restoration retention/fracture.
1 secondary outcome
Marginal Adaptation
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.
Rafael Scheffer, 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 Phase 4 study testing 1-step self-etch approach (SE), selective enamel etching (SEE) and 1-step self-etch for double time (SE2X) 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 7 inclusion and 5 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: 6 montths). 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.