Tooth DiseasesNCT03708510
Clinical Evaluation of Two Low-shrinkage Composites
A study testing Restorative materials- Filtek Silorane, Restorative materials-Kalore and Preparation-Er,Cr:YSGG Laser in people with Tooth Diseases, run by Hacettepe University.
Trial summary
Patients with 4 occlusal lesions in molar teeth will be included. Occlusal cavities will be prepared either by Er,Cr:YSGG laser (LS) or conventional diamond bur (BR). Cavities will be restored with Filtek Silorane (3M-ESPE) (SR) and with Kalore (GC) (KR) according to the manufacturers' instructions. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Diseases
- What is being tested?
- Restorative materials- Filtek Silorane, Restorative materials-Kalore and Preparation-Er,Cr:YSGG Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2011to 1 Sep 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age range will be 18 to 60
- patients should have at least 4 occlusal caries lesions require restoration
- healty periodontal status
- a good likelihood of recall availability
Who cannot join
- poor gingival health
- adverse medical history
- potential behavioral problems
About this study
Official title: Clinical Evaluation of Two Low-shrinkage Composites After Different Preparation Techniques
Patients with 4 occlusal lesions in molar teeth will be included. Occlusal cavities will be prepared either by Er,Cr:YSGG laser (LS) or conventional diamond bur (BR). Cavities will be restored with Filtek Silorane (3M-ESPE) (SR) and with Kalore (GC) (KR) according to the manufacturers' instructions. All restorative procedures will be performed by one operator and the restorations will be examined by two evaluators according to the FDI (World Dental Federation) criteria at baseline and at 6-month, 1-, 2-,3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-year. Patients' satisfaction about the preparation methods will be evaluated with a survey. Pearson Chi-Square test will be used for statistical analyze(p=0.05).
- Conditions
- Tooth Diseases
- Being tested
- Restorative materials- Filtek Silorane, Restorative materials-Kalore, Preparation-Er,Cr:YSGG Laser, Preparation- Diamond Bur
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restorative materials- Filtek SiloraneDevice
Filtek Silorane
Restorative materials-KaloreDevice
Kalore
Preparation-Er,Cr:YSGG LaserDevice
Er,Cr:YSGG Laser
Preparation- Diamond BurDevice
Bur
| Study group | Role | What they receive |
|---|---|---|
| Filtek Silorane-Er,Cr:YSGG Laser | Experimental | Not described Receives: Device: Restorative materials- Filtek Silorane; Device: Preparation-Er,Cr:YSGG Laser |
| Filtek Silorane- Diamond Bur | Experimental | Not described Receives: Device: Restorative materials- Filtek Silorane; Device: Preparation- Diamond Bur |
| Kalore- Er,Cr:YSGG Laser | Experimental | Not described Receives: Device: Restorative materials-Kalore; Device: Preparation-Er,Cr:YSGG Laser |
| Kalore- Diamond Bur | Experimental | Not described Receives: Device: Restorative materials-Kalore; Device: Preparation- Diamond Bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of different low-shrinkage composites and preparations
Evaluations according to FDI criteria
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 May 2011
- Primary completion1 Sep 2011
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiseasesStudies 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, Outcomes assessor
- Enrolment
- 18 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
- NCT03708510
- Sponsor's protocol ID
- Kalore-Silorane, Laser-Bur
- Status last verified
- Apr 2024
- First submitted
- 14 Oct 2018
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Two Low-shrinkage Composites After Different Preparation Techniques
- ClinicalTrials.gov ID
- NCT03708510
- Acronym / sponsor ID
- Kalore-Silorane, Laser-Bur
- Conditions
- Tooth Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 May 2011 (actual)
- Primary completion
- 1 Sep 2011 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 17 Oct 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.
Patients with 4 occlusal lesions in molar teeth will be included. Occlusal cavities will be prepared either by Er,Cr:YSGG laser (LS) or conventional diamond bur (BR). Cavities will be restored with Filtek Silorane (3M-ESPE) (SR) and with Kalore (GC) (KR) according to the manufacturers' instructions. All restorative procedures will be performed by one operator and the restorations will be examined by two evaluators according to the FDI (World Dental Federation) criteria at baseline and at 6-month, 1-, 2-,3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-year. Patients' satisfaction about the preparation methods will be evaluated with a survey. Pearson Chi-Square test will be used for statistical analyze(p=0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Filtek Silorane-Er,Cr:YSGG Laser | Experimental | Device: Restorative materials- Filtek Silorane, Device: Preparation-Er,Cr:YSGG Laser |
| Filtek Silorane- Diamond Bur | Experimental | Device: Restorative materials- Filtek Silorane, Device: Preparation- Diamond Bur |
| Kalore- Er,Cr:YSGG Laser | Experimental | Device: Restorative materials-Kalore, Device: Preparation-Er,Cr:YSGG Laser |
| Kalore- Diamond Bur | Experimental | Device: Restorative materials-Kalore, Device: Preparation- Diamond Bur |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age range will be 18 to 60
- patients should have at least 4 occlusal caries lesions require restoration
- healty periodontal status
- a good likelihood of recall availability
Key exclusion criteria (3 listed)
- poor gingival health
- adverse medical history
- potential behavioral problems
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 |
|---|---|---|
| Restorative materials- Filtek SiloraneFiltek Silorane | Device | Filtek Silorane- Diamond Bur, Filtek Silorane-Er,Cr:YSGG Laser |
| Restorative materials-KaloreKalore | Device | Kalore- Diamond Bur, Kalore- Er,Cr:YSGG Laser |
| Preparation-Er,Cr:YSGG LaserEr,Cr:YSGG Laser | Device | Filtek Silorane-Er,Cr:YSGG Laser, Kalore- Er,Cr:YSGG Laser |
| Preparation- Diamond BurBur | Device | Filtek Silorane- Diamond Bur, Kalore- Diamond Bur |
Primary outcome
Clinical performance of different low-shrinkage composites and preparations
Time frame: 10 years
Evaluations according to FDI 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 17 Apr 2024.
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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 Restorative materials- Filtek Silorane, Restorative materials-Kalore and Preparation-Er,Cr:YSGG Laser in people with Tooth Diseases, 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 4 inclusion and 3 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 17 Apr 2024. 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 performance of different low-shrinkage composites and preparations (time frame: 10 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 17 Apr 2024.