CariesNCT04973761
Quality of Life for Children With Zirconium Anteroir Crowns Versus Strip Composite Crowns
A study testing Zirconium crowns and Strip composite crowns in people with Caries, run by Minia University at 1 site in Egypt.
Trial summary
Early Childhood Oral Health Impact Scale (ECOHIS) will be used for detection of oral health related quality of life for children using strip composite crowns versus zirconium crowns at 6 and 12 months Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Zirconium crowns and Strip composite crowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 1 Jan 2021
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children Cariuos primary anteroir teeth Cooperative children
Who cannot join
- children with systemic diseases Children with bad oral habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaliation of Oral Health Quality of Life for Children With Zirconium Crowns Versus Anteroir Strip Composite Crowns After 6 and 12 Months
Early Childhood Oral Health Impact Scale (ECOHIS) will be used for detection of oral health related quality of life for children using strip composite crowns versus zirconium crowns at 6 and 12 months
- Conditions
- Caries
- Being tested
- Zirconium crowns, Strip composite crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconium crownsOther
Prefabricated pirmary anteroir teeth zirconium crowns
Strip composite crownsOther
Strip composite crowns
| Study group | Role | What they receive |
|---|---|---|
| Strip composite crowns | Other | Not described Receives: Other: Strip composite crowns |
| Zirconium crowns | Experimental | Not described Receives: Other: Zirconium crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health related quality of life
Early Childhood Oral Health Impact Scale (ECOHIS).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Mar 2018
- Primary completion1 Nov 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by Minia 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Mahmoud, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973761
- Sponsor's protocol ID
- 401
- Status last verified
- Aug 2021
- First submitted
- 17 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaliation of Oral Health Quality of Life for Children With Zirconium Crowns Versus Anteroir Strip Composite Crowns After 6 and 12 Months
- ClinicalTrials.gov ID
- NCT04973761
- Acronym / sponsor ID
- 401
- Conditions
- Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 22 Jul 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.
Early Childhood Oral Health Impact Scale (ECOHIS) will be used for detection of oral health related quality of life for children using strip composite crowns versus zirconium crowns at 6 and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strip composite crowns | Other | Other: Strip composite crowns |
| Zirconium crowns | Experimental | Other: Zirconium crowns |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy children Cariuos primary anteroir teeth Cooperative children
Key exclusion criteria (1 listed)
- children with systemic diseases Children with bad oral habits
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 |
|---|---|---|
| Zirconium crownsPrefabricated pirmary anteroir teeth zirconium crowns | Other | Zirconium crowns |
| Strip composite crownsStrip composite crowns | Other | Strip composite crowns |
Primary outcome
Oral health related quality of life
Time frame: 12 months
Early Childhood Oral Health Impact Scale (ECOHIS).
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 3 Aug 2021.
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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 Zirconium crowns and Strip composite crowns in people with Caries, run by Minia University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 3 Aug 2021. 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 Egypt. 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?
Oral health related quality of life (time frame: 12 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 3 Aug 2021.