Tooth WearNCT03415516
Clinical Comparison of Universal Adhesives in Terms of Different Application Modes on the Restoration of NCCLs
A study testing Gluma Universal, All Bond Universal and Single Bond2 in people with Tooth Wear, run by Hacettepe University.
Trial summary
The aim of this randomized, controlled, prospective clinical trial is to evaluate the performances of two different universal adhesives and an etch\&rinse adhesive in restoration of non-caries cervical lesions. Twenty patients will receive restorations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear
- What is being tested?
- Gluma Universal, All Bond Universal and Single Bond2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 1 Nov 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being 18 years or older,
- having no medical or behavioral problems preventing then from attending review visits,
- having at least 7 tooth with NCCLs (d) having antagonist teeth.
Who cannot join
- Exlusion criteria will be:
- poor gingival health,
- uncontrolled, rampant caries,
- bruxism,
- removable partial dentures,
- xerostomia.
About this study
The aim of this randomized, controlled, prospective clinical trial is to evaluate the performances of two different universal adhesives and an etch\&rinse adhesive in restoration of non-caries cervical lesions. Twenty patients will receive restorations. Lesions will be divided into 7 groups according to adhesive systems and application modes: GSE: Gluma Universal- self etch, GSL: Gluma Universal-selective etching, GER: Gluma Universal-etch\&rinse, ASE: All Bond Universal- self etch, ASL: All Bond Universal- selective etching, AER: All Bond Universal- etch\&rinse, SB (Control): Single Bond2+etch\&rinse. Restorations (nano-hybrid composite) will be scored with regard to retention, marginal discoloration, marginal adaptation, recurrent caries and post operative sensitivity using modified USPHS criteria after 48 months. Two examiners who is not involved in the placement of restorations will conduct the evaluations. Descriptive statistics will be performed using Chi-square tests.
- Conditions
- Tooth Wear
- Being tested
- Gluma Universal, All Bond Universal, Single Bond2
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluma UniversalDevice
Adhesive systems
All Bond UniversalDevice
Adhesive systems
Single Bond2Drug
Adhesive systems
| Study group | Role | What they receive |
|---|---|---|
| Gluma Universal, self-etch mode (GSE) | Experimental | Not described Receives: Device: Gluma Universal |
| Gluma Universal, selective etching (GSL) | Experimental | Not described Receives: Device: Gluma Universal |
| Gluma Universal, etch&rinse (GER) | Experimental | Not described Receives: Device: Gluma Universal |
| All Bond Universal, self-etch (ASE) | Experimental | Not described Receives: Device: All Bond Universal |
| All Bond Universal, selective etching (ASL) | Experimental | Not described Receives: Device: All Bond Universal |
| All Bond Universal, etch&rinse (AER) | Experimental | Not described Receives: Device: All Bond Universal |
| Single Bond2, etch&rinse (SBU) | Experimental | Not described Receives: Drug: Single Bond2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performances of different adhesives
Two year examinations according to USPHS criteria
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Jul 2015
- Primary completion1 Nov 2015
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth WearStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fatma Dilşad Öz, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415516
- Sponsor's protocol ID
- Universal Clinical NCCLs
- Status last verified
- Sep 2021
- First submitted
- 23 Dec 2017
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Universal Adhesives in Terms of Different Application Modes on the Restoration of NCCLs
- ClinicalTrials.gov ID
- NCT03415516
- Acronym / sponsor ID
- Universal Clinical NCCLs
- Conditions
- Tooth Wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Nov 2015 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 30 Jan 2018 (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 aim of this randomized, controlled, prospective clinical trial is to evaluate the performances of two different universal adhesives and an etch\&rinse adhesive in restoration of non-caries cervical lesions. Twenty patients will receive restorations. Lesions will be divided into 7 groups according to adhesive systems and application modes: GSE: Gluma Universal- self etch, GSL: Gluma Universal-selective etching, GER: Gluma Universal-etch\&rinse, ASE: All Bond Universal- self etch, ASL: All Bond Universal- selective etching, AER: All Bond Universal- etch\&rinse, SB (Control): Single Bond2+etch\&rinse. Restorations (nano-hybrid composite) will be scored with regard to retention, marginal discoloration, marginal adaptation, recurrent caries and post operative sensitivity using modified USPHS criteria after 48 months. Two examiners who is not involved in the placement of restorations will conduct the evaluations. Descriptive statistics will be performed using Chi-square tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Gluma Universal, self-etch mode (GSE) | Experimental | Device: Gluma Universal |
| Gluma Universal, selective etching (GSL) | Experimental | Device: Gluma Universal |
| Gluma Universal, etch&rinse (GER) | Experimental | Device: Gluma Universal |
| All Bond Universal, self-etch (ASE) | Experimental | Device: All Bond Universal |
| All Bond Universal, selective etching (ASL) | Experimental | Device: All Bond Universal |
| All Bond Universal, etch&rinse (AER) | Experimental | Device: All Bond Universal |
| Single Bond2, etch&rinse (SBU) | Experimental | Drug: Single Bond2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being 18 years or older,
- having no medical or behavioral problems preventing then from attending review visits,
- having at least 7 tooth with NCCLs (d) having antagonist teeth.
Key exclusion criteria (6 listed)
- poor gingival health,
- uncontrolled, rampant caries,
- bruxism,
- removable partial dentures,
- xerostomia.
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 |
|---|---|---|
| Gluma UniversalAdhesive systems | Device | Gluma Universal, etch&rinse (GER), Gluma Universal, selective etching (GSL), Gluma Universal, self-etch mode (GSE) |
| All Bond UniversalAdhesive systems | Device | All Bond Universal, etch&rinse (AER), All Bond Universal, selective etching (ASL), All Bond Universal, self-etch (ASE) |
| Single Bond2Adhesive systems | Drug | Single Bond2, etch&rinse (SBU) |
Primary outcome
Clinical performances of different adhesives
Time frame: Two years
Two year examinations according to USPHS criteria
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 14 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Gluma Universal, All Bond Universal and Single Bond2 in people with Tooth Wear, run by Hacettepe University.
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 6 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 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical performances of different adhesives (time frame: Two 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 14 Sep 2021.