Dental CariesNCT06583759
Evaluation of Prefabricated CAD/CAM PEEK Crowns Used in Primary Molars
A study testing Full coverage Crowns in people with Dental Caries, run by Alexandria University at 2 sites in Egypt.
Trial summary
Fifty healthy cooperative children will be randomly allocated to two groups. Group I (test group) will receive CAD/CAM PEEK crowns, while group II (control group) will receive SSC. The crowns will be evaluated clinically and radiographically. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Full coverage Crowns
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 14 Nov 2024to 30 Apr 2026
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant Inclusion Criteria
- Age ranges from 5 - 7 years.
- Children free of any systemic disease or special health care need (ASA I).(30)
- Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4) (Appendix I).(31)
- Patients whose parents will give their consent to participate.
- Tooth Inclusion Criteria
Show all 14Show fewer
- Mandibular second primary molars that are indicated for full coverage:(7)
- Present opposing tooth.
- Tooth Exclusion Criteria:
- Root resorption affecting more than one third of the root length.
- Clinical signs and symptoms of irreversible pulpitis or non-vitality. (Appendix II) (32)
- Fistula or abscess related to the selected tooth clinically and radiographically.
- Non restorable crowns.
- Signs of mobility or bone resorption.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dentistry, Alexandria University
Alexandria
Faculty of Dentistry
Alexandria
About this study
Official title: Evaluation of Prefabricated CAD/CAM PEEK Crowns Used in Primary Molars: A Randomised Controlled Clinical Trial
Fifty healthy cooperative children will be randomly allocated to two groups. Group I (test group) will receive CAD/CAM PEEK crowns, while group II (control group) will receive SSC. The crowns will be evaluated clinically and radiographically.
Read the detailed description
A two-arm randomized controlled clinical trial. A total of 50 healthy children aged 5-7 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 Frankl behavioral rating scale. Each child selected will have at least one mandibular second primary molar indicated for full coverage. Written informed consent will be obtained from their guardians. Participants will be randomly allocated into two groups according to the crown that will be used. Group I (test group) will receive CAD/CAM PEEK crowns, while group II (control group) will receive SSC. Using Modified Ryge's Criteria, the crowns will be examined clinically for anatomic form, restoration staining, marginal discoloration, colour match, surface roughness, marginal adaptation, proximal contact, occlusal wear of crown, wear of opposing tooth, and presence of cracks. Gingival and Plaques index scores will be recorded, as well as chairside time, patient and parental satisfaction. The patients will be recalled at 1 week then 3, 6 and 12 months for clinical follow-up. Radiographs will be taken at 6 and 12 months.
- Conditions
- Dental Caries
- Being tested
- Full coverage 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.
Full coverage CrownsProcedure or surgery
The crown will be prepared accordingly. Try in of the best fitted crown will be done and cementation.
| Study group | Role | What they receive |
|---|---|---|
| Stainless Steel Crowns | Active comparator | Not described Receives: Procedure: Full coverage Crowns |
| PEEK Crowns | Experimental | Not described Receives: Procedure: Full coverage Crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation of the crown using Modified Ryge Criteria
Measured: Day 0, 1 week , 3 months, 6 months , 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start14 Nov 2024
- Primary completion15 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Alexandria 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, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodaina Helmy, Alexandria University
- Investigators
- Aly Sharaf, Professor, Pediatric Dentistry, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583759
- Sponsor's protocol ID
- AlexU
- Status last verified
- May 2026
- First submitted
- 2 Sep 2024
- Last updated
- 2 Jun 2026
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prefabricated CAD/CAM PEEK Crowns Used in Primary Molars: A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06583759
- Acronym / sponsor ID
- AlexU
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 4 Sep 2024 (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.
Fifty healthy cooperative children will be randomly allocated to two groups. Group I (test group) will receive CAD/CAM PEEK crowns, while group II (control group) will receive SSC. The crowns will be evaluated clinically and radiographically.
Detailed description
A two-arm randomized controlled clinical trial. A total of 50 healthy children aged 5-7 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 Frankl behavioral rating scale. Each child selected will have at least one mandibular second primary molar indicated for full coverage. Written informed consent will be obtained from their guardians. Participants will be randomly allocated into two groups according to the crown that will be used. Group I (test group) will receive CAD/CAM PEEK crowns, while group II (control group) will receive SSC. Using Modified Ryge's Criteria, the crowns will be examined clinically for anatomic form, restoration staining, marginal discoloration, colour match, surface roughness, marginal adaptation, proximal contact, occlusal wear of crown, wear of opposing tooth, and presence of cracks. Gingival and Plaques index scores will be recorded, as well as chairside time, patient and parental satisfaction. The patients will be recalled at 1 week then 3, 6 and 12 months for clinical follow-up. Radiographs will be taken at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stainless Steel Crowns | Active comparator | Procedure: Full coverage Crowns |
| PEEK Crowns | Experimental | Procedure: Full coverage Crowns |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Participant Inclusion Criteria
- Tooth Inclusion Criteria
- Root resorption affecting more than one third of the root length.
- Clinical signs and symptoms of irreversible pulpitis or non-vitality. (Appendix II) (32)
- Fistula or abscess related to the selected tooth clinically and radiographically.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Full coverage CrownsThe crown will be prepared accordingly. Try in of the best fitted crown will be done and cementation. | Procedure or surgery | PEEK Crowns, Stainless Steel Crowns |
Primary outcome
Clinical Evaluation of the crown using Modified Ryge Criteria
Time frame: Day 0, 1 week , 3 months, 6 months , 12 months
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 2 Jun 2026.
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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.
Aly Sharaf, Professor, Pediatric Dentistry study director
Alexandria University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full coverage Crowns in people with Dental Caries, run by Alexandria University at 2 sites 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 14 inclusion and 0 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Evaluation of the crown using Modified Ryge Criteria (time frame: Day 0, 1 week , 3 months, 6 months , 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 2 Jun 2026.