Trial of Labor; FailureNCT05590806
The Effect of Ground and Unground Enamel on the Clinical Performance of Direct Composite Build-ups
A study testing Direct composite build-ups in people with Trial of Labor; Failure, run by Istanbul University.
Trial summary
Twenty-four patients participated in the study. Patients received direct composite build-ups for diastema closure. Read more about this study
- Who is it for?
- Ages 14 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Trial of Labor; Failure
- What is being tested?
- Direct composite build-ups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2011to 30 Jun 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 14 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- good oral hygiene, no periodontal or pulpal disease, interarch tooth size discrepancies (Bolton discrepancy) after orthodontic treatment
Who cannot join
- uncontrollable parafunctions, insufficient or poor oral hygiene, periodontal or gingival disease
About this study
Official title: The Effect of Ground and Unground Enamel on the Clinical Performance of Direct Composite Build-ups After Orthodontic Treatment: Five Years of Follow-up
Twenty-four patients participated in the study. Patients received direct composite build-ups for diastema closure.
Read the detailed description
The restorations were performed separately by grounding and ungrounding the enamel on the proximal surfaces in symmetrical teeth.
- Conditions
- Trial of Labor; Failure
- Being tested
- Direct composite build-ups
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct composite build-upsOther
Direct composite build-ups application
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Restoration Receives: Other: Direct composite build-ups |
| Arm 2 | Experimental | Evaluate Receives: Other: Direct composite build-ups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 May 2011
- Primary completion30 Oct 2015
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trial of Labor; FailureStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Demirci, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590806
- Sponsor's protocol ID
- 2011-97
- Status last verified
- Sep 2023
- First submitted
- 19 Oct 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ground and Unground Enamel on the Clinical Performance of Direct Composite Build-ups After Orthodontic Treatment: Five Years of Follow-up
- ClinicalTrials.gov ID
- NCT05590806
- Acronym / sponsor ID
- 2011-97
- Conditions
- Trial of Labor; Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 May 2011 (actual)
- Primary completion
- 30 Oct 2015 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 21 Oct 2022 (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.
Twenty-four patients participated in the study. Patients received direct composite build-ups for diastema closure.
Detailed description
The restorations were performed separately by grounding and ungrounding the enamel on the proximal surfaces in symmetrical teeth.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Direct composite build-upsRestoration |
| Arm 2 | Experimental | Other: Direct composite build-upsEvaluate |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- good oral hygiene, no periodontal or pulpal disease, interarch tooth size discrepancies (Bolton discrepancy) after orthodontic treatment
Key exclusion criteria (1 listed)
- uncontrollable parafunctions, insufficient or poor oral hygiene, periodontal or gingival disease
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 |
|---|---|---|
| Direct composite build-upsDirect composite build-ups application | Other | Arm 1, Arm 2 |
Primary outcome
Success rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- 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.
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 Direct composite build-ups in people with Trial of Labor; Failure, run by Istanbul 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 1 inclusion and 1 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 Sep 2023. 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?
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?
Success rate (time frame: 5 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 28 Sep 2023.