Dental CariesNCT05959382
Evaluation of Clinical Success of Restorations Using Different Magnification Aids
A study testing Dental Loupe and Dental Operation Microscope in people with Dental Caries, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effect of using a loupe and dental operating microscope with different magnifications on the success of class II direct composite restorations. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Dental Loupe and Dental Operation Microscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 30 Dec 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good oral and dental care of the patient,
- The need for at least 1 Class II restoration at a depth of D2 in the posterior group teeth,
- No crowding in the tooth to be restored, tooth contact and antagonist,
- The relevant tooth is vital,
- Absence of pain on percussion and palpation of the tooth.
- Absence of any pathology in the periapical tissues in radiographic evaluation,
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- The patient was informed about the study and accepted the study,
- Having agreed to attend 1 month, 6 month and 12 month control sessions,
- The patient has no systemic disease,
Who cannot join
- Presence of severe periodontal disease,
- Teeth that cannot be insulated, malposed or overloaded or not loaded at all,
- Periodontal and endodontic removal of the relevant tooth is healthy,
- the patient is undergoing orthodontic treatment,
- Recording of dry mouth is set,
- Severe bruxism habit,
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to investigate the effect of using a loupe and dental operating microscope with different magnifications on the success of class II direct composite restorations.
Read the detailed description
A total of 130 class II, D2 deep caries teeth of 85 patients were randomly distributed to the naked eye, 3x magnification loupe, 5x magnification loupe, 8.5x magnification dental operating microscope (DOM) groups, and direct composite restorations were made with these magnification aids. carried out. Clearfil SE Bond 2 and Clearfil Majesty Posterior composite were used in all restorations. The restorations were evaluated using FDI criteria at 1,6 and 12-month periods, and restorations were scored between 1 and 5 for all criteria.
- Conditions
- Dental Caries
- Being tested
- Dental Loupe, Dental Operation Microscope
- Keywords
- dental loupe, restoration success, FDI criteria
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental LoupeDevice
Magnification aid
Dental Operation MicroscopeDevice
Magnification aid
| Study group | Role | What they receive |
|---|---|---|
| with no magnification aid treatment | No intervention | Dental caries treatment with no magnification aid |
| with x2 dental loupe | Active comparator | Dental caries treatment with x2 dental loupe Receives: Device: Dental Loupe |
| with x5 dental loupe | Active comparator | Dental caries treatment with x5 dental loupe Receives: Device: Dental Loupe |
| with dental operation microscope | Active comparator | Dental caries treatment with dental operation microscope Receives: Device: Dental Operation Microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Restoration Success using FDI Criteria
FDI criteria were categorized into three groups [3]: esthetic (four criteria), functional (three criteria) and biological (one criterion) parameters
Measured: a week after dental treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Oct 2021
- Primary completion20 Dec 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Model description
- It has 4 groups in total. The treatments were carried out * with no magnification aid * with x2 loupe * with x5 loupe * with Dental operation microscope
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ipek çubukçu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959382
- Sponsor's protocol ID
- ipek001
- Status last verified
- Jul 2023
- First submitted
- 16 Jul 2023
- Last updated
- 25 Jul 2023
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Success of Restorations Using Different Magnification Aids
- ClinicalTrials.gov ID
- NCT05959382
- Acronym / sponsor ID
- ipek001
- Conditions
- Dental Caries
- Keywords
- dental loupe, restoration success, FDI criteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 25 Jul 2023 (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.
This study aimed to investigate the effect of using a loupe and dental operating microscope with different magnifications on the success of class II direct composite restorations.
Detailed description
A total of 130 class II, D2 deep caries teeth of 85 patients were randomly distributed to the naked eye, 3x magnification loupe, 5x magnification loupe, 8.5x magnification dental operating microscope (DOM) groups, and direct composite restorations were made with these magnification aids. carried out. Clearfil SE Bond 2 and Clearfil Majesty Posterior composite were used in all restorations. The restorations were evaluated using FDI criteria at 1,6 and 12-month periods, and restorations were scored between 1 and 5 for all criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- It has 4 groups in total. The treatments were carried out * with no magnification aid * with x2 loupe * with x5 loupe * with Dental operation microscope
| Arm | Type | Receives |
|---|---|---|
| with no magnification aid treatment | No intervention | –Dental caries treatment with no magnification aid |
| with x2 dental loupe | Active comparator | Device: Dental LoupeDental caries treatment with x2 dental loupe |
| with x5 dental loupe | Active comparator | Device: Dental LoupeDental caries treatment with x5 dental loupe |
| with dental operation microscope | Active comparator | Device: Dental Operation MicroscopeDental caries treatment with dental operation microscope |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Good oral and dental care of the patient,
- The need for at least 1 Class II restoration at a depth of D2 in the posterior group teeth,
- No crowding in the tooth to be restored, tooth contact and antagonist,
- The relevant tooth is vital,
- Absence of pain on percussion and palpation of the tooth.
Key exclusion criteria (7 listed)
- Presence of severe periodontal disease,
- Teeth that cannot be insulated, malposed or overloaded or not loaded at all,
- Periodontal and endodontic removal of the relevant tooth is healthy,
- the patient is undergoing orthodontic treatment,
- Recording of dry mouth is set,
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 |
|---|---|---|
| Dental LoupeMagnification aid | Device | with x2 dental loupe, with x5 dental loupe |
| Dental Operation MicroscopeMagnification aid | Device | with dental operation microscope |
Primary outcome
Evaluation of Restoration Success using FDI Criteria
Time frame: a week after dental treatment
FDI criteria were categorized into three groups [3]: esthetic (four criteria), functional (three criteria) and biological (one criterion) parameters
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 25 Jul 2023.
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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 Dental Loupe and Dental Operation Microscope in people with Dental Caries, run by Ataturk 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 9 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: finished, as of the sponsor's last update on 25 Jul 2023. 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?
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?
Evaluation of Restoration Success using FDI Criteria (time frame: a week after dental treatment). 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 25 Jul 2023.