Decay, DentalNCT04479046
Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns
A study testing PMMA crowns in people with Decay, Dental, run by Ain Shams University at 1 site in Egypt.
Trial summary
Evaluation of PMMA pediatric crowns Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Decay, Dental
- What is being tested?
- PMMA crowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Jun 2019
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children included in the study should conform to the following criteria:
- Aged 5-8 years old
- Medically free
- Patient should suffer from extensively decayed primary lower second molar that will undergo pulpotomy.
- The anticipated exfoliation date of the selected primary teeth has to be more than 12 months from the date of the study start.
Who cannot join
- Children with the following criteria will be totally excluded from the study:
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- Children who are extremely uncooperative and difficult to manage.
- Children suffering from any medical conditions that can't be managed in the clinic.
- Teeth with decay extending beneath the free gingival margin.
- Teeth that were grossly broken down, that cannot be restored.
- Presence of uncontrolled bleeding.
- Clinical or radiographic evidence of non-vitality such as presence of an abscess or a sinus, obvious discoloration, and premature hypermobility.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Ain Shams University
Heliopolis, Cairo Governorate, 11737
About this study
Evaluation of PMMA pediatric crowns
Read the detailed description
The aim of the present study is to evaluate the PMMA crowns regarding the following aspects:
- Clinical evaluation of PMMA crowns regarding wear of opposing teeth when compared to zirconia crowns and stainless steel crowns after 6 months, and 12 months.
II. Color stability of PMMA crowns and zirconia crowns after 6 months, and 12 months.
III. Gingival health of restored teeth after 6 months, and 12 months. IV. Patient's satisfaction regarding the appearance and clinical performance of PMMA crowns when compared to stainless steel crowns and zirconia crowns through a given questionnaire.
- Conditions
- Decay, Dental
- Being tested
- PMMA crowns
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMMA crownsOther
New type of pediatric crowns
| Study group | Role | What they receive |
|---|---|---|
| Stainless steel crowns | Active comparator | 3M ESPE Receives: Other: PMMA crowns |
| Zirconia crowns | Experimental | Nu Smile Receives: Other: PMMA crowns |
| PMMA crowns | Experimental | Dental Direkt Receives: Other: PMMA crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival health
Plaque index
Measured: 6 months
Crown survival
Fracture
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decay, DentalStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Aboushady, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479046
- Sponsor's protocol ID
- NAP202
- Status last verified
- Jul 2020
- First submitted
- 27 Dec 2019
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns
- ClinicalTrials.gov ID
- NCT04479046
- Acronym / sponsor ID
- NAP202
- Conditions
- Decay, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 21 Jul 2020 (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.
Evaluation of PMMA pediatric crowns
Detailed description
The aim of the present study is to evaluate the PMMA crowns regarding the following aspects:
- Clinical evaluation of PMMA crowns regarding wear of opposing teeth when compared to zirconia crowns and stainless steel crowns after 6 months, and 12 months.
II. Color stability of PMMA crowns and zirconia crowns after 6 months, and 12 months.
III. Gingival health of restored teeth after 6 months, and 12 months. IV. Patient's satisfaction regarding the appearance and clinical performance of PMMA crowns when compared to stainless steel crowns and zirconia crowns through a given questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stainless steel crowns | Active comparator | Other: PMMA crowns3M ESPE |
| Zirconia crowns | Experimental | Other: PMMA crownsNu Smile |
| PMMA crowns | Experimental | Other: PMMA crownsDental Direkt |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children included in the study should conform to the following criteria:
Key exclusion criteria (8 listed)
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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 |
|---|---|---|
| PMMA crownsNew type of pediatric crowns | Other | PMMA crowns, Stainless steel crowns, Zirconia crowns |
Primary outcome
Gingival health
Time frame: 6 months
Plaque index
Crown survival
Time frame: 6 months
Fracture
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 21 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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 PMMA crowns in people with Decay, Dental, run by Ain Shams 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 5 inclusion and 8 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 21 Jul 2020. 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?
Gingival health (time frame: 6 months). The study lists 2 primary outcomes in all. 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 21 Jul 2020.