Restoration of Primary Molars With CAD/CAM CrownsNCT04144062
Primary Molars Restoration Using Different Pediatric Crowns.
A study testing CAD/CAM crowns in people with Restoration of Primary Molars With CAD/CAM Crowns, run by Nehal Salman at 1 site in Egypt.
Trial summary
study aims to compare hybrid ceramic CAD/CAM and prefabricated zirconia ans stainless steel crowns restoring primary molars through In-vivo evaluation of the clinical outcomes in terms of; crown retention, stain resistance and periodontal and gingival health as well as parental/child satisfaction. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Restoration of Primary Molars With CAD/CAM Crowns
- What is being tested?
- CAD/CAM crowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2021to 25 Nov 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age range of the patients from 5 to 8 years old.
- Have no history of spontaneous pain or swelling.
- Patients willing to return for follow-up examinations and evaluation.
- Medically free patients or with controlled systemic disease ASA I or II.
- No active periodontal diseases.
- Patients with posterior pulpotomized tooth/teeth indicated for crown restoration (e.g. 2-3mm of teeth above cement-enamel junction).
Who cannot join
- Children with intellectual, severe emotional or behavioral problems.
- Presence of parafunctional habits such as clenching or bruxism.
- Abnormal tooth mobility, gingival swelling, fistulous tract, or non-vital pulps.
- Non-restorable teeth.
- Radiographic positive signs of thickened or interrupted periodontal membrane space, internal root resorption, periapical or furcal radiolucency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CAD/CAM Crowns Versus Prefabricated Zirconia and Stainless Steel Crowns for Restoration of Primary Molars: A Prospective Study.
study aims to compare hybrid ceramic CAD/CAM and prefabricated zirconia ans stainless steel crowns restoring primary molars through In-vivo evaluation of the clinical outcomes in terms of; crown retention, stain resistance and periodontal and gingival health as well as parental/child satisfaction.
- Being tested
- CAD/CAM crowns
- Keywords
- Crowns, Zirconium, Computer-Aided Design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM crownsOther
CAD/CAM crowns
| Study group | Role | What they receive |
|---|---|---|
| Zirconia crowns | Active comparator | Not described Receives: Other: CAD/CAM crowns |
| CAD/CAM crowns | Active comparator | Not described Receives: Other: CAD/CAM crowns |
| Stainless-steel crowns | Active comparator | Not described Receives: Other: CAD/CAM crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success
United States Public Health Service (USPHS) index
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start25 Nov 2021
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restoration of Primary Molars With CAD/CAM CrownsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nehal Salman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nehal Salman, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144062
- Sponsor's protocol ID
- 318
- Status last verified
- Feb 2021
- First submitted
- 28 Oct 2019
- Last updated
- 14 May 2025
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAD/CAM Crowns Versus Prefabricated Zirconia and Stainless Steel Crowns for Restoration of Primary Molars: A Prospective Study.
- ClinicalTrials.gov ID
- NCT04144062
- Acronym / sponsor ID
- 318
- Keywords
- Crowns, Zirconium, Computer-Aided Design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nehal SalmanUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 30 Oct 2019 (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.
study aims to compare hybrid ceramic CAD/CAM and prefabricated zirconia ans stainless steel crowns restoring primary molars through In-vivo evaluation of the clinical outcomes in terms of; crown retention, stain resistance and periodontal and gingival health as well as parental/child satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zirconia crowns | Active comparator | Other: CAD/CAM crowns |
| CAD/CAM crowns | Active comparator | Other: CAD/CAM crowns |
| Stainless-steel crowns | Active comparator | Other: CAD/CAM crowns |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age range of the patients from 5 to 8 years old.
- Have no history of spontaneous pain or swelling.
- Patients willing to return for follow-up examinations and evaluation.
- Medically free patients or with controlled systemic disease ASA I or II.
- No active periodontal diseases.
Key exclusion criteria (5 listed)
- Children with intellectual, severe emotional or behavioral problems.
- Presence of parafunctional habits such as clenching or bruxism.
- Abnormal tooth mobility, gingival swelling, fistulous tract, or non-vital pulps.
- Non-restorable teeth.
- Radiographic positive signs of thickened or interrupted periodontal membrane space, internal root resorption, periapical or furcal radiolucency
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 |
|---|---|---|
| CAD/CAM crownsCAD/CAM crowns | Other | CAD/CAM crowns, Stainless-steel crowns, Zirconia crowns |
Primary outcome
clinical success
Time frame: 1 year
United States Public Health Service (USPHS) index
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 14 May 2025.
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 CAD/CAM crowns in people with Restoration of Primary Molars With CAD/CAM Crowns, run by Nehal Salman 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 5 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 14 May 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?
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?
clinical success (time frame: 1 year). 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 14 May 2025; AzTrials last refreshed its copy on 28 Oct 2026.