Restoration of Posterior TeethNCT04694690
Clinical Performance of Different Resin Cements
A study testing Self adhesive resin cement and Resin cement in people with Restoration of Posterior Teeth, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The clinical performance of different resin cements in adhesion of hybrid ceramic inlay and onlay restorations produced with CAD/CAM will be evaluated and compared. After obtaining a signed informed consent form from all the patients, all restorations will be placed by a single clinician. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Restoration of Posterior Teeth
- What is being tested?
- Self adhesive resin cement and Resin cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2018to 20 Aug 2024
- 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
- Healthy individuals with or without systemic disease
- Patiens older than 18 years old
- Good oral health
- Patients who at least have1 large and deep carious lesion or broken restoration in a vital tooth
- Patients who agreed to participate in the study after being informed about this study
Who cannot join
- Patient with periodontal disease
- Patients with partial dentures
- Patients with bruxism
- Patients with malooclusion
- Non vital or endodontically treated teeth
- Preparetions under the cemento-enamel junction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry
Ankara, 06060
About this study
Official title: Clinical Performance of Resin Cements in the Adhesion of CAD/CAM Restorations
The clinical performance of different resin cements in adhesion of hybrid ceramic inlay and onlay restorations produced with CAD/CAM will be evaluated and compared. After obtaining a signed informed consent form from all the patients, all restorations will be placed by a single clinician. All hyrid ceramic restorations (Cerasmart, GC, Tokyo, Japan) will be produced using the same CAD/CAM CEREC Omnicam (Sirona Dental, Bensheim, Germany) system. 70 restorations will be divided into 2 groups: a self adhesive resin cement (RelyX U200 Automix, 3M ESPE, Seefeld, Germany), and an adhesive cement (G-Cem LinkForce, GC, Tokyo, Japan) which is applied after surface treatment (etch\&rinse). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12, 18, 24, 36 and 48 months. Descriptive statistics will be performed using Friedman test and Chi-square test.
- Conditions
- Restoration of Posterior Teeth
- Being tested
- Self adhesive resin cement, Resin cement
- Keywords
- CAD/CAM, Inlay, Onlay, Hybrid ceramic, Adhesive resin cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self adhesive resin cementOther
Also called RelyX U 200
Self adhesive resin cement
Resin cementOther
Also called G-Cem LinkForce
Resin Cement system used after surface treatment
| Study group | Role | What they receive |
|---|---|---|
| RelyX U200 Automix Self Adhesive Resin Cement | Experimental | Self Adhesive Resin Cement Receives: Other: Self adhesive resin cement |
| G-Cem LinkForce Resin Cement | Active comparator | Resin Cement system used after surface treatment Receives: Other: Resin cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
18 months- Modified United States Public Health Service
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start20 Nov 2018
- Primary completion20 Feb 2019
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restoration of Posterior TeethStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simge Canatan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694690
- Sponsor's protocol ID
- CAD/CAM-hybrid
- Status last verified
- Feb 2024
- First submitted
- 2 Jan 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Resin Cements in the Adhesion of CAD/CAM Restorations
- ClinicalTrials.gov ID
- NCT04694690
- Acronym / sponsor ID
- CAD/CAM-hybrid
- Conditions
- Restoration of Posterior Teeth
- Keywords
- CAD/CAM, Inlay, Onlay, Hybrid ceramic, Adhesive resin cement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 5 Jan 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 clinical performance of different resin cements in adhesion of hybrid ceramic inlay and onlay restorations produced with CAD/CAM will be evaluated and compared. After obtaining a signed informed consent form from all the patients, all restorations will be placed by a single clinician. All hyrid ceramic restorations (Cerasmart, GC, Tokyo, Japan) will be produced using the same CAD/CAM CEREC Omnicam (Sirona Dental, Bensheim, Germany) system. 70 restorations will be divided into 2 groups: a self adhesive resin cement (RelyX U200 Automix, 3M ESPE, Seefeld, Germany), and an adhesive cement (G-Cem LinkForce, GC, Tokyo, Japan) which is applied after surface treatment (etch\&rinse). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12, 18, 24, 36 and 48 months. Descriptive statistics will be performed using Friedman test and Chi-square test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RelyX U200 Automix Self Adhesive Resin Cement | Experimental | Other: Self adhesive resin cementSelf Adhesive Resin Cement |
| G-Cem LinkForce Resin Cement | Active comparator | Other: Resin cementResin Cement system used after surface treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy individuals with or without systemic disease
- Patiens older than 18 years old
- Good oral health
- Patients who at least have1 large and deep carious lesion or broken restoration in a vital tooth
- Patients who agreed to participate in the study after being informed about this study
Key exclusion criteria (6 listed)
- Patient with periodontal disease
- Patients with partial dentures
- Patients with bruxism
- Patients with malooclusion
- Non vital or endodontically treated teeth
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 |
|---|---|---|
| Self adhesive resin cementAlso: RelyX U 200Self adhesive resin cement | Other | RelyX U200 Automix Self Adhesive Resin Cement |
| Resin cementAlso: G-Cem LinkForceResin Cement system used after surface treatment | Other | G-Cem LinkForce Resin Cement |
Primary outcome
Clinical performance
Time frame: 18 months
18 months- Modified United States Public Health Service
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self adhesive resin cement and Resin cement in people with Restoration of Posterior Teeth, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 5 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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 Turkey (Türkiye). 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?
Clinical performance (time frame: 18 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 28 Feb 2024.