Non Carious Cervical LesionNCT04756349
Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical Lesions
A study testing composite resin restoration in people with Non Carious Cervical Lesion, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
The objective of this randomized, double-blind clinical trial is to evaluate the clinical performance of non-carious cervicals adhesive restorations using three self-etching adhesives containing HEMA and 10-MDP monomers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Carious Cervical Lesion
- What is being tested?
- composite resin restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Feb 2020to 12 Feb 2022
- 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
- Good oral hygiene
- Absence of periodontal disease
- Presence of at least 02 non-carious cervical lesions
Who cannot join
- Presence of non-carious cervical lesion in non-vital teeth
- Occlusal instability
- Presence of orthodontic appliance
- Presence of removable partial dental prosthesis
- High risk of caries (presence of three or more active caries lesions)
- Xerostomia
Show all 9Show fewer
- Bruxism
- Patients allergic to base materials monomers
- Patients who do not accept the project conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical Lesions - A Two Years Randomized Double Blind Study
The objective of this randomized, double-blind clinical trial is to evaluate the clinical performance of non-carious cervicals adhesive restorations using three self-etching adhesives containing HEMA and 10-MDP monomers.
Read the detailed description
Sixty teeth (n = 20 for each group) will be randomized into 03 groups: Clearfil SE (contains MDP and HEMA), Optibond All-inOne (contains HEMA) and Prime and Bond Universal (contains neither monomer) dispatch). Restorations will be performed by a single operator, and no mechanical retention will be performed under the cavity. After 6, 12 and 24 months, the restorations will be evaluated by two calibrated examiners, using modified USPHS criteria for retention (kappa = 1.00) and adaptation / marginal color (kappa = 0.81), and the results will be analysed by Fisher and Kruskal-Wallis, respectively. An intragroup analysis will be performed using the Cochran test (for retention) and Wilcoxon (for marginal adaptation / staining).
- Conditions
- Non Carious Cervical Lesion
- Being tested
- composite resin restoration
- Keywords
- adhesives, dental bonding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
composite resin restorationOther
Also called composite resin restorations with Clearfil SE adhesive, composite resin restorations with Optibond All-in-One adhesive, composite resin restorations with Prime & Bond Universal adhesive
All patients will receive adhesive composite resin restorations. There will be 3 groups (different adhesives): Clearfil SE, Optibond All-in-One and Prime \& Bond Universal.
| Study group | Role | What they receive |
|---|---|---|
| Clearfil SE | Active comparator | Group containing 10-MDP and HEMA monomers Receives: Other: composite resin restoration |
| Optibond All-in-One | Active comparator | Group containing HEMA monomer Receives: Other: composite resin restoration |
| Prime & Bond Universal | Active comparator | Control Group containing other monomers Receives: Other: composite resin restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate of restoration
The retention rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms):
Alpha = retained. Charlie = mobility or loss.
Measured: 01 year
Retention rate of restoration
The retention rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms):
Alpha = retained. Charlie = mobility or loss.
Measured: 02 years
Secondary outcomes (4)
Marginal staining rate of restoration
The marginal staining rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms):
Alpha = no staining. Bravo = superficial staining (localized or generalized). Charlie = deep staining (localized or generalized).
Measured: 01 year
Marginal staining rate of restoration
The marginal staining rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms):
Alpha = no staining. Bravo = superficial staining (localized or generalized). Charlie = deep staining (localized or generalized).
Measured: 02 years
Marginal Adaptation rate of restoration
The marginal adaptation rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms):
Alpha = no visible evidence of a crack along the edge, the explorer will not penetrate.
Bravo = visible evidence of a crack along the margin, dentin unexposed, clinically acceptable.
Charlie = explorer penetrates the crack, dentin exposed, clinically unacceptable.
Measured: 01 year
Marginal Adaptation rate of restoration
The marginal adaptation rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms):
Alpha = no visible evidence of a crack along the edge, the explorer will not penetrate.
Bravo = visible evidence of a crack along the margin, dentin unexposed, clinically acceptable.
Charlie = explorer penetrates the crack, dentin exposed, clinically unacceptable.
Measured: 02 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start12 Feb 2020
- Primary completion12 Feb 2021
- Study completion12 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Carious Cervical LesionStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Para
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecy Martins Silva, Universidade Federal do Para
- Investigators
- Roberta Oliveira, Msc, Principal investigator, Federal University of ParáBrennda De Paula, Msc, Study chair, Federal University of ParáCecy Silva, PhD, Study director, Federal University of Pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756349
- Sponsor's protocol ID
- UFPara
- Status last verified
- May 2022
- First submitted
- 5 Feb 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical Lesions - A Two Years Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT04756349
- Acronym / sponsor ID
- UFPara
- Conditions
- Non Carious Cervical Lesion
- Keywords
- adhesives, dental bonding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 12 Feb 2022 (actual)
- First posted
- 16 Feb 2021 (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.
The objective of this randomized, double-blind clinical trial is to evaluate the clinical performance of non-carious cervicals adhesive restorations using three self-etching adhesives containing HEMA and 10-MDP monomers.
Detailed description
Sixty teeth (n = 20 for each group) will be randomized into 03 groups: Clearfil SE (contains MDP and HEMA), Optibond All-inOne (contains HEMA) and Prime and Bond Universal (contains neither monomer) dispatch). Restorations will be performed by a single operator, and no mechanical retention will be performed under the cavity. After 6, 12 and 24 months, the restorations will be evaluated by two calibrated examiners, using modified USPHS criteria for retention (kappa = 1.00) and adaptation / marginal color (kappa = 0.81), and the results will be analysed by Fisher and Kruskal-Wallis, respectively. An intragroup analysis will be performed using the Cochran test (for retention) and Wilcoxon (for marginal adaptation / staining).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clearfil SE | Active comparator | Other: composite resin restorationGroup containing 10-MDP and HEMA monomers |
| Optibond All-in-One | Active comparator | Other: composite resin restorationGroup containing HEMA monomer |
| Prime & Bond Universal | Active comparator | Other: composite resin restorationControl Group containing other monomers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Good oral hygiene
- Absence of periodontal disease
- Presence of at least 02 non-carious cervical lesions
Key exclusion criteria (9 listed)
- Presence of non-carious cervical lesion in non-vital teeth
- Occlusal instability
- Presence of orthodontic appliance
- Presence of removable partial dental prosthesis
- High risk of caries (presence of three or more active caries lesions)
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 |
|---|---|---|
| composite resin restorationAlso: composite resin restorations with Clearfil SE adhesive, composite resin restorations with Optibond All-in-One adhesive, composite resin restorations with Prime & Bond Universal adhesiveAll patients will receive adhesive composite resin restorations. There will be 3 groups (different adhesives): Clearfil SE, Optibond All-in-One and Prime \& Bond Universal. | Other | Clearfil SE, Optibond All-in-One, Prime & Bond Universal |
Primary outcome
Retention rate of restoration
Time frame: 01 year
The retention rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = retained. Charlie = mobility or loss.
Retention rate of restoration
Time frame: 02 years
The retention rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = retained. Charlie = mobility or loss.
4 secondary outcomes
Marginal staining rate of restoration
Time frame: 01 year
Marginal staining rate of restoration
Time frame: 02 years
Marginal Adaptation rate of restoration
Time frame: 01 year
Marginal Adaptation rate of restoration
Time frame: 02 years
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 24 May 2022.
- Individual participant dataSharing planned: No
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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.
Roberta Oliveira, Msc principal investigator
Federal University of Pará
Brennda De Paula, Msc study chair
Federal University of Pará
Cecy Silva, PhD study director
Federal University of Pará
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing composite resin restoration in people with Non Carious Cervical Lesion, run by Universidade Federal do Para 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 3 inclusion and 9 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 24 May 2022. 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 rate of restoration (time frame: 01 year). The study lists 2 primary outcomes in all. 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 24 May 2022.