Self-etchNCT03798184
Clinical Performance of Prime&Bond Active in Self-etch or Selective-etch Mode With or Without Bioglass
A study testing Non-carious cervical lesion restoration in people with Self-etch and Selective-etch, run by University of Valencia at 1 site in Spain.
Trial summary
Composite restoration of non-carious cervical lesions has always been a challenge for the clinician, considering that the most frequent cause of failure is retention loss. Adhesion of composite restoration may be obtained by following four different etching techniques: total-etch in three steps, total-etch in two… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Self-etch, Selective-etch, Bioactive Glass
- What is being tested?
- Non-carious cervical lesion restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteSpain
- Study dates
- 19 Nov 2018to Nov 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years without systemic disease.
- Presence of a non-carious cervical lesion with a minimum of 1.5 mm in depth and extent to dentin.
- Non-carious cervical lesions in premolars and molars.
Who cannot join
- Presence of rampant caries or advanced periodontal disease.
- Consumption of > 2 cigarette pack/ day.
- Presence of severe xerostomia or bruxism.
- Methacrylate allergy.
- Pregnancy.
- Teeth with pulpal and/or periapical pathology, and endodontically treated teeth are excluded from the study.
- Teeth with previous pulp capping or previous class V restorations will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Blind Clinical Trial, Four-armed Parallel of Clinical Performance of Prime&Bond Active in Self-etch or Selective-etch With or Without Bioglass
Composite restoration of non-carious cervical lesions has always been a challenge for the clinician, considering that the most frequent cause of failure is retention loss.
Adhesion of composite restoration may be obtained by following four different etching techniques: total-etch in three steps, total-etch in two steps, self-etch in two steps, and self-etch in one step. Nowadays the tendency is to simplify the adhesive classic protocols. With the introduction of universal adhesives such as Prime\&Bond Active (Dentsply Sirona) it is possible to obtain a total-etch pattern (enamel and dentine) without the classic etching technique with orthophosphoric acid.
Read more
On the other hand, there has been an increase in the awareness of the importance of remaining dental tissue preservation, avoiding preparation of a cavity. This is why it is now preferable to use bioactive glass in order to increase micromechanical retention on the dental surface, instead of the classical approach of preparing the surface with burs.
To date, there are no studies evaluating the clinical performance of the universal adhesive Prime\&Bond Active on direct resin composite restoration of non-carious cervical lesions neither in a selective-etch mode (enamel etching) or a self-etch mode (no etching) or using sandblasting with bioactive glass. Therefore, the main objective of the study is to evaluate the retention rate of composite restorations using Prime\&Bond Active and a previous sandblasted surface with bioglass in a three-year follow-up, as well as the presence of marginal discoloration, marginal integrity and marginal caries.
Read the detailed description
The protocol to be followed in the study is as follows:
- Obtention of a written informed consent of all participants.
- Complete medical and dental clinical record.
- Administration of anesthesia and absolute rubber dam isolation.
- Cavity cleaning with a prophylactic brush and rubber cup with pumice.
- Randomly assigning each non-carious cervical lesion to one of the four experimental groups: 5.1. Selective enamel etching and surface roughening with bioglass 5.2. Selective enamel etching without surface roughening. 5.3. Self-etch and surface roughening with bioglass. 5.4. Self-etch without surface roughening.
- In experimental groups which need surface roughening (group 5.1 and 5.3), sandblasting with bioactive glass will be used in enamel.
- In experimental groups with selective enamel etch (5.1 and 5.2), 37 % orthophosphoric acid is applied for 15 seconds in enamel, followed by profuse washing with air/water spray for ten seconds and dried using air for 10 seconds without desiccating dentin. In groups 5.3 and 5.4 this step is omitted.
- Application of universal adhesive Prime\&Bond Active on enamel and dentin for 20 seconds. Subsequently, evaporation of the solvent is realized by applying air for 5 seconds and then light curing for 20 seconds.
- Application of a "bulk fill" composite resin and light curing, following manufacturer's instructions.
- Finishing and polishing of the restoration.
- Monitoring and follow up: visits will be performed at six months, one year, two years and three years. In each evaluation, two independent clinicians who do not participate in the clinical procedures will evaluate each direct composite restoration according to USPHS criteria (Modified United States Public Health Service).
The primary objective is to evaluate the retention of the restoration. The secondary objectives are to evaluate marginal discoloration, marginal integrity and marginal caries.
- Conditions
- Self-etch, Selective-etch, Bioactive Glass, Direct Resin Composite Restoration, Non-carious Cervical Lesion, Universal Adhesive
- Being tested
- Non-carious cervical lesion restoration
- Keywords
- Prime&Bond Active, Bioactive glass, non-carious cervical lesion, direct resin composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-carious cervical lesion restorationProcedure or surgery
Restoration of non-carious cervical lesions with Prime\&Bond Active in self-etch or selective-etch mode with or without bioglass
| Study group | Role | What they receive |
|---|---|---|
| Selective-etch with bioglass surface roughening | Experimental | Not described Receives: Procedure: Non-carious cervical lesion restoration |
| Selective-etch without bioglass surface roughening | Active comparator | Not described Receives: Procedure: Non-carious cervical lesion restoration |
| Self-etch with bioglass surface roughening | Experimental | Not described Receives: Procedure: Non-carious cervical lesion restoration |
| Self-etch without bioglass surface roughening | Active comparator | Not described Receives: Procedure: Non-carious cervical lesion restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
Presence of resin composite restorations of non-carious cervical lesions at the three-year follow-up examination.
Measured: Three years
Secondary outcomes (3)
Marginal discoloration
Presence of marginal staining between the restoration and tooth will be evaluated following USPHS criteria (Modified United States Public Health Service)
Measured: Three years
Marginal integrity
The quality of the interface between restoration and tooth will be evaluated following USPHS criteria (Modified United States Public Health Service)
Measured: Three years
Marginal caries
The presence of clinical diagnosis of caries will be evaluated following USPHS criteria (Modified United States Public Health Service)
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start19 Nov 2018
- Primary completionNov 2019 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-etchStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Pasarín Linares, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798184
- Sponsor's protocol ID
- 2/2018
- Status last verified
- Jan 2019
- First submitted
- 18 Nov 2018
- Last updated
- 9 Jan 2019
- 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 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Blind Clinical Trial, Four-armed Parallel of Clinical Performance of Prime&Bond Active in Self-etch or Selective-etch With or Without Bioglass
- ClinicalTrials.gov ID
- NCT03798184
- Acronym / sponsor ID
- 2/2018
- Conditions
- Self-etch, Selective-etch, Bioactive Glass, Direct Resin Composite Restoration, Non-carious Cervical Lesion, Universal Adhesive
- Keywords
- Prime&Bond Active, Bioactive glass, non-carious cervical lesion, direct resin composite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 9 Jan 2019 (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.
Composite restoration of non-carious cervical lesions has always been a challenge for the clinician, considering that the most frequent cause of failure is retention loss.
Adhesion of composite restoration may be obtained by following four different etching techniques: total-etch in three steps, total-etch in two steps, self-etch in two steps, and self-etch in one step. Nowadays the tendency is to simplify the adhesive classic protocols. With the introduction of universal adhesives such as Prime\&Bond Active (Dentsply Sirona) it is possible to obtain a total-etch pattern (enamel and dentine) without the classic etching technique with orthophosphoric acid.
On the other hand, there has been an increase in the awareness of the importance of remaining dental tissue preservation, avoiding preparation of a cavity. This is why it is now preferable to use bioactive glass in order to increase micromechanical retention on the dental surface, instead of the classical approach of preparing the surface with burs.
To date, there are no studies evaluating the clinical performance of the universal adhesive Prime\&Bond Active on direct resin composite restoration of non-carious cervical lesions neither in a selective-etch mode (enamel etching) or a self-etch mode (no etching) or using sandblasting with bioactive glass. Therefore, the main objective of the study is to evaluate the retention rate of composite restorations using Prime\&Bond Active and a previous sandblasted surface with bioglass in a three-year follow-up, as well as the presence of marginal discoloration, marginal integrity and marginal caries.
Detailed description
The protocol to be followed in the study is as follows:
- Obtention of a written informed consent of all participants.
- Complete medical and dental clinical record.
- Administration of anesthesia and absolute rubber dam isolation.
- Cavity cleaning with a prophylactic brush and rubber cup with pumice.
- Randomly assigning each non-carious cervical lesion to one of the four experimental groups: 5.1. Selective enamel etching and surface roughening with bioglass 5.2. Selective enamel etching without surface roughening. 5.3. Self-etch and surface roughening with bioglass. 5.4. Self-etch without surface roughening.
- In experimental groups which need surface roughening (group 5.1 and 5.3), sandblasting with bioactive glass will be used in enamel.
- In experimental groups with selective enamel etch (5.1 and 5.2), 37 % orthophosphoric acid is applied for 15 seconds in enamel, followed by profuse washing with air/water spray for ten seconds and dried using air for 10 seconds without desiccating dentin. In groups 5.3 and 5.4 this step is omitted.
- Application of universal adhesive Prime\&Bond Active on enamel and dentin for 20 seconds. Subsequently, evaporation of the solvent is realized by applying air for 5 seconds and then light curing for 20 seconds.
- Application of a "bulk fill" composite resin and light curing, following manufacturer's instructions.
- Finishing and polishing of the restoration.
- Monitoring and follow up: visits will be performed at six months, one year, two years and three years. In each evaluation, two independent clinicians who do not participate in the clinical procedures will evaluate each direct composite restoration according to USPHS criteria (Modified United States Public Health Service).
The primary objective is to evaluate the retention of the restoration. The secondary objectives are to evaluate marginal discoloration, marginal integrity and marginal caries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Selective-etch with bioglass surface roughening | Experimental | Procedure: Non-carious cervical lesion restoration |
| Selective-etch without bioglass surface roughening | Active comparator | Procedure: Non-carious cervical lesion restoration |
| Self-etch with bioglass surface roughening | Experimental | Procedure: Non-carious cervical lesion restoration |
| Self-etch without bioglass surface roughening | Active comparator | Procedure: Non-carious cervical lesion restoration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 18 years without systemic disease.
- Presence of a non-carious cervical lesion with a minimum of 1.5 mm in depth and extent to dentin.
- Non-carious cervical lesions in premolars and molars.
Key exclusion criteria (7 listed)
- Presence of rampant caries or advanced periodontal disease.
- Consumption of > 2 cigarette pack/ day.
- Presence of severe xerostomia or bruxism.
- Methacrylate allergy.
- Pregnancy.
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 |
|---|---|---|
| Non-carious cervical lesion restorationRestoration of non-carious cervical lesions with Prime\&Bond Active in self-etch or selective-etch mode with or without bioglass | Procedure or surgery | Selective-etch with bioglass surface roughening, Selective-etch without bioglass surface roughening, Self-etch with bioglass surface roughening, Self-etch without bioglass surface roughening |
Primary outcome
Retention rate
Time frame: Three years
Presence of resin composite restorations of non-carious cervical lesions at the three-year follow-up examination.
3 secondary outcomes
Marginal discoloration
Time frame: Three years
Marginal integrity
Time frame: Three years
Marginal caries
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
Related trials for Self-etch
Not yet recruiting
A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding
White Spot Lesions, Enamel Demineralization
Active, not recruiting
Clinical Evaluation of Composite Restorations Using Two-steps Universal Adhesive in Non-carious Cervical Lesion (NCCL)
Non-carious Cervical Lesion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-carious cervical lesion restoration in people with Self-etch and Selective-etch, run by University of Valencia at 1 site in Spain.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Jan 2019. 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 Spain. 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?
Results are not available in the source record.
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 rate (time frame: Three years). 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 9 Jan 2019.