Primary Teeth Crown Dimensions in a Sample of Egyptian ChildrenDigital AnalysNCT06874218
Digital Analysis of Primary Teeth Crown Dimensions and Clinical Evaluation in a Sample of Egyptian Children
A study testing prefabricated CAD-CAM Zirconia crowns according to Egyptian sizes. in people with Primary Teeth Crown Dimensions in a Sample of Egyptian Children, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study will be conducted to: 1. Digitally determine crown dimensions of primary teeth in a sample of Egyptian children. 2. Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Primary Teeth Crown Dimensions in a Sample of Egyptian Children
- What is being tested?
- prefabricated CAD-CAM Zirconia crowns according to Egyptian sizes.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children having normal fully erupted primary teeth and with no morphological variations.
- Children with no history of orthodontic or prosthodontic treatment.
- Children with normal overjet and overbite.
- Sound interproximal \& buccal / lingual walls with or without minimal occlusal pits \& fissure incipient caries.
- No previous interproximal \& buccal / lingual restorations.
- Intact mesial and distal marginal ridge.
Who cannot join
- Children with gross carious lesions.
- Children with hypo-mineralization, hypoplasia and fracture primary teeth.
- Children with medical disabilities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study will be conducted to:
- Digitally determine crown dimensions of primary teeth in a sample of Egyptian children.
- Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors
Read the detailed description
Currently, there is limited availability of primary tooth crown measurement for Egyptian children. SO, this study aims to digitally determine tooth crown dimensions of primary teeth in a group of Egyptian children and compare prefabricated zirconia crowns according to the Egyptian crown sizes with the international standard zirconia crowns sizes for primary upper central incisors.
- Being tested
- prefabricated CAD-CAM Zirconia crowns according to Egyptian sizes.
- Keywords
- Teeth Dimensions, Digital Analysis, Egyptian Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prefabricated CAD-CAM Zirconia crowns according to Egyptian sizes.Device
compare prefabricated zirconia crowns according to the Egyptian crown sizes with the international standard zirconia crowns sizes for primary upper central incisors
| Study group | Role | What they receive |
|---|---|---|
| Primary Teeth Crown Dimensions in a Sample of Egyptian Children | Other | Digitally determine crown dimensions of primary teeth in a sample of Egyptian children Receives: Device: prefabricated CAD-CAM Zirconia crowns according to Egyptian sizes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
crown dimensions of primary teeth in a sample of Egyptian children.
Digitally determine crown dimensions of primary teeth in a sample of Egyptian children using intraoral scanner and Digital measurements of teeth dimensions by Meshmixer analyzing software.
Measured: intra operative
Secondary outcomes (1)
Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors.
Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors by Modified United States Public Health Service (USPHS) criteria, and the gingival state near the primary performed crown will be assessed by using the Silness\& Loe indices (1964) to record plaque index and gingival index.
Measured: intra operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Teeth Crown Dimensions in a Sample of Egyptian ChildrenStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Not applicable
- Intervention model
- Single group
- Model description
- Digitally determine crown dimensions of primary teeth in a sample of Egyptian children.
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Abdelwahed Melegy, Tanta University
- Investigators
- Reham Abdelwahed Melegy, MSC, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874218
- Sponsor's protocol ID
- Digital Analysis of teeth
- Other IDs
- PED1-252299
- Acronym
- Digital Analys
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: for patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Analysis of Primary Teeth Crown Dimensions and Clinical Evaluation in a Sample of Egyptian Children
- ClinicalTrials.gov ID
- NCT06874218
- Acronym / sponsor ID
- Digital Analys / Digital Analysis of teeth
- Keywords
- Teeth Dimensions, Digital Analysis, Egyptian Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 13 Mar 2025 (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 aim of this study will be conducted to:
- Digitally determine crown dimensions of primary teeth in a sample of Egyptian children.
- Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors
Detailed description
Currently, there is limited availability of primary tooth crown measurement for Egyptian children. SO, this study aims to digitally determine tooth crown dimensions of primary teeth in a group of Egyptian children and compare prefabricated zirconia crowns according to the Egyptian crown sizes with the international standard zirconia crowns sizes for primary upper central incisors.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Digitally determine crown dimensions of primary teeth in a sample of Egyptian children.
| Arm | Type | Receives |
|---|---|---|
| Primary Teeth Crown Dimensions in a Sample of Egyptian Children | Other | Device: prefabricated CAD-CAM Zirconia crowns according to Egyptian sizes.Digitally determine crown dimensions of primary teeth in a sample of Egyptian children |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children having normal fully erupted primary teeth and with no morphological variations.
- Children with no history of orthodontic or prosthodontic treatment.
- Children with normal overjet and overbite.
- Sound interproximal \& buccal / lingual walls with or without minimal occlusal pits \& fissure incipient caries.
- No previous interproximal \& buccal / lingual restorations.
Key exclusion criteria (3 listed)
- Children with gross carious lesions.
- Children with hypo-mineralization, hypoplasia and fracture primary teeth.
- Children with medical disabilities
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 |
|---|---|---|
| prefabricated CAD-CAM Zirconia crowns according to Egyptian sizes.compare prefabricated zirconia crowns according to the Egyptian crown sizes with the international standard zirconia crowns sizes for primary upper central incisors | Device | Primary Teeth Crown Dimensions in a Sample of Egyptian Children |
Primary outcome
crown dimensions of primary teeth in a sample of Egyptian children.
Time frame: intra operative
Digitally determine crown dimensions of primary teeth in a sample of Egyptian children using intraoral scanner and Digital measurements of teeth dimensions by Meshmixer analyzing software.
1 secondary outcome
Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors.
Time frame: intra operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No. for patient privacy
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.
Reham Abdelwahed Melegy, MSC principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prefabricated CAD-CAM Zirconia crowns according to Egyptian sizes. in people with Primary Teeth Crown Dimensions in a Sample of Egyptian Children, run by Tanta 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 13 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reham Abbelwahed Melegy, MD (+2 01014602137, reham_abdelwahed@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
crown dimensions of primary teeth in a sample of Egyptian children. (time frame: intra operative). 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 13 Mar 2025.