Dental Caries in ChildrenNCT05034003
Success of Zirconia and Composite Strip Crowns for Primary Incisors
A study testing Zirconia crown and composite strip crown in people with Dental Caries in Children, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and composite strip crowns bonded on primary incisors Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Zirconia crown and composite strip crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 1 Jan 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients and parent of the patients who accept to participate and sign the informed consent
- Patients who have at least two primary maxillary incisor with caries that require crown restoration
- Teeth that have healthy lamina dura and periodontal ligament
- Teeth with no mobility and enough root length
- Patients that have good cooperation to the procedure
Who cannot join
- Patients and parent of the patients who don't accept to participate and sign the informed consent
- Teeth that are previously restored
- Patients who are uncooperative
- Teeth that doesn't have opposing primary incisors
- Patients who have bruxism or deep-bite
- Teeth that are close to be erupted
- Teeth that have vital or non-vital pulp therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Performance of Zirconia and Composite Strip Crowns for Primary Incisors
The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and composite strip crowns bonded on primary incisors
Read the detailed description
Zirconia and composite strip crowns will be placed on at least two primary incisor teeth, in a split mouth design. A caries-free primary incisor tooth will be used as control. 100 patients will be included in the study. The teeth will be randomized into two groups according to the crown type.
Group 1: Zirconia crown 2: Composite Strip Crown 3: Control tooth. Plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension, color match of the crowns and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos will be taken directly after treatment and at control appointments.
The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.
- Conditions
- Dental Caries in Children
- Being tested
- Zirconia crown, composite strip crown
- Keywords
- zirconia crowns, composite strip crowns, dental caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia crownDevice
Esthetic crowns for capping primary incisor with caries
composite strip crownDevice
Esthetic resin restoration for primary incisor with caries
| Study group | Role | What they receive |
|---|---|---|
| zirconia crowns | Experimental | Zirconia crowns placed on primary incisor teeth Receives: Device: Zirconia crown |
| composite strip crowns | Experimental | composite strip crowns placed on primary incisor teeth Receives: Device: composite strip crown |
| Control tooth | No intervention | Caries-free primary incisor tooth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of zirconia and composite strip crowns that showed successful retention over two years
Long-term clinical success of zirconia and composite strip crowns placed on primary incisors
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Aug 2019
- Primary completion1 Aug 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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, Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafer Cavit Cehreli, DDS, PhD, Hacettepe University
- Investigators
- zafer c cehreli, Principal investigator, Hacettepe university , Faculty of dentistry, ankara/Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034003
- Sponsor's protocol ID
- anterior crown rest
- Status last verified
- Apr 2023
- First submitted
- 24 Aug 2021
- Last updated
- 7 Apr 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 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Performance of Zirconia and Composite Strip Crowns for Primary Incisors
- ClinicalTrials.gov ID
- NCT05034003
- Acronym / sponsor ID
- anterior crown rest
- Conditions
- Dental Caries in Children
- Keywords
- zirconia crowns, composite strip crowns, dental caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 5 Sep 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 purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and composite strip crowns bonded on primary incisors
Detailed description
Zirconia and composite strip crowns will be placed on at least two primary incisor teeth, in a split mouth design. A caries-free primary incisor tooth will be used as control. 100 patients will be included in the study. The teeth will be randomized into two groups according to the crown type.
Group 1: Zirconia crown 2: Composite Strip Crown 3: Control tooth. Plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension, color match of the crowns and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos will be taken directly after treatment and at control appointments.
The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| zirconia crowns | Experimental | Device: Zirconia crownZirconia crowns placed on primary incisor teeth |
| composite strip crowns | Experimental | Device: composite strip crowncomposite strip crowns placed on primary incisor teeth |
| Control tooth | No intervention | –Caries-free primary incisor tooth |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients and parent of the patients who accept to participate and sign the informed consent
- Patients who have at least two primary maxillary incisor with caries that require crown restoration
- Teeth that have healthy lamina dura and periodontal ligament
- Teeth with no mobility and enough root length
- Patients that have good cooperation to the procedure
Key exclusion criteria (7 listed)
- Patients and parent of the patients who don't accept to participate and sign the informed consent
- Teeth that are previously restored
- Patients who are uncooperative
- Teeth that doesn't have opposing primary incisors
- Patients who have bruxism or deep-bite
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 |
|---|---|---|
| Zirconia crownEsthetic crowns for capping primary incisor with caries | Device | zirconia crowns |
| composite strip crownEsthetic resin restoration for primary incisor with caries | Device | composite strip crowns |
Primary outcome
Number of zirconia and composite strip crowns that showed successful retention over two years
Time frame: 2 years
Long-term clinical success of zirconia and composite strip crowns placed on primary incisors
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 7 Apr 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.
zafer c cehreli principal investigator
Hacettepe university , Faculty of dentistry, ankara/Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia crown and composite strip crown in people with Dental Caries in Children, 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 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 7 Apr 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?
Number of zirconia and composite strip crowns that showed successful retention over two years (time frame: 2 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 7 Apr 2023.