Primary Molar ToothNCT07738471
Assessment of Clinical Success of Custom-Made Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars
A study testing Custom made zirconia crowns and Prefabricated zirconia crown in people with Primary Molar Tooth and Pulpotomies Primary Teeth, run by Cairo University.
Trial summary
Early childhood caries often results in extensive destruction of primary molars, requiring pulpotomy followed by full-coronal restoration to ensure long-term function and durability. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Primary Molar Tooth, Pulpotomies Primary Teeth
- What is being tested?
- Custom made zirconia crowns and Prefabricated zirconia crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-8 years.
- Primary molars with deep carious lesions extending to the middle third of the dentin as confirmed radiographically.
- Absence of root caries.
- Absence of periapical or inter-radicular radiolucency.
- Absence of internal or external root resorption.
- Teeth in the opposite arch are present and in normal occlusion.
- Willingness to participate and adhere to the follow-up appointments
Who cannot join
- Children with systemic health issues.
- Children with periodontal diseases.
- Children exhibiting parafunctional habits.
- Uncooperative children (Frankl scale (score 1 and 2).
About this study
Official title: Assessment of Clinical Success of Custom-Made Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars: A Randomized Clinical Trial
Early childhood caries often results in extensive destruction of primary molars, requiring pulpotomy followed by full-coronal restoration to ensure long-term function and durability. Zirconia crowns have become a popular esthetic restorative option; however, limited evidence is available regarding the clinical performance of custom-made zirconia crowns compared with prefabricated zirconia crowns. This randomized controlled clinical trial aims to compare the clinical performance of custom-made and prefabricated zirconia crowns placed on pulpotomized primary molars. Clinical performance will be evaluated using standardized clinical and radiographic outcome measures over the follow-up period to determine whether custom-made zirconia crowns provide comparable or improved outcomes.
- Conditions
- Primary Molar Tooth, Pulpotomies Primary Teeth
- Being tested
- Custom made zirconia crowns, Prefabricated zirconia crown
- Keywords
- Zirconia Crown, Customer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom made zirconia crownsDevice
Participants will receive custom-made zirconia crowns placed on pulpotomized primary molars according to the study protocol.
Prefabricated zirconia crownDevice
prefabricated zirconia crown selected according to tooth size and cemented on pulpotomized primary molars
| Study group | Role | What they receive |
|---|---|---|
| Custom-Made Zirconia Crowns | Experimental | Participants will receive custom-made zirconia crowns placed on pulpotomized primary molars according to the study protocol. Receives: Device: Custom made zirconia crowns |
| : Prefabricated Zirconia Crowns | Active comparator | Participants will receive prefabricated zirconia crowns placed on pulpotomized primary molars according to the study protocol. Receives: Device: Custom made zirconia crowns; Device: Prefabricated zirconia crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical sucess
Clinical success will be determined according to the Modified USPHS criteria. Overall clinical success will be based on the combined assessment of marginal adaptation, retention, crown contour, and fracture.
Measured: 12month
Secondary outcomes (1)
Mean Gingival index
Mean Gingival Index Score
Gingival health will be assessed using the Gingival Index with a William periodontal probe.
Score 0: Normal gingiva.
Score 1: Mild inflammation with slight color change.
Score 2: Moderate inflammation with redness and bleeding on probing.
Score 3: Severe inflammation with edema, redness, ulceration, and spontaneous or probing-induced bleeding.
Measured: 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Molar ToothStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Sabry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738471
- Sponsor's protocol ID
- * PEDO-PHD-2026-001
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves pediatric participants, and sharing of individual-level data may compromise participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical Success of Custom-Made Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07738471
- Acronym / sponsor ID
- * PEDO-PHD-2026-001
- Conditions
- Primary Molar Tooth, Pulpotomies Primary Teeth
- Keywords
- Zirconia Crown, Customer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 31 Jul 2026 (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 caries often results in extensive destruction of primary molars, requiring pulpotomy followed by full-coronal restoration to ensure long-term function and durability. Zirconia crowns have become a popular esthetic restorative option; however, limited evidence is available regarding the clinical performance of custom-made zirconia crowns compared with prefabricated zirconia crowns. This randomized controlled clinical trial aims to compare the clinical performance of custom-made and prefabricated zirconia crowns placed on pulpotomized primary molars. Clinical performance will be evaluated using standardized clinical and radiographic outcome measures over the follow-up period to determine whether custom-made zirconia crowns provide comparable or improved outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom-Made Zirconia Crowns | Experimental | Device: Custom made zirconia crownsParticipants will receive custom-made zirconia crowns placed on pulpotomized primary molars according to the study protocol. |
| : Prefabricated Zirconia Crowns | Active comparator | Device: Custom made zirconia crowns, Device: Prefabricated zirconia crownParticipants will receive prefabricated zirconia crowns placed on pulpotomized primary molars according to the study protocol. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 5-8 years.
Key exclusion criteria (4 listed)
- Children with systemic health issues.
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 |
|---|---|---|
| Custom made zirconia crownsParticipants will receive custom-made zirconia crowns placed on pulpotomized primary molars according to the study protocol. | Device | : Prefabricated Zirconia Crowns, Custom-Made Zirconia Crowns |
| Prefabricated zirconia crownprefabricated zirconia crown selected according to tooth size and cemented on pulpotomized primary molars | Device | : Prefabricated Zirconia Crowns |
Primary outcome
Clinical sucess
Time frame: 12month
Clinical success will be determined according to the Modified USPHS criteria. Overall clinical success will be based on the combined assessment of marginal adaptation, retention, crown contour, and fracture.
1 secondary outcome
Mean Gingival index
Time frame: 12month
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 31 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves pediatric participants, and sharing of individual-level data may compromise participant confidentiality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Custom made zirconia crowns and Prefabricated zirconia crown in people with Primary Molar Tooth and Pulpotomies Primary Teeth, run by Cairo University.
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 7 inclusion and 4 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 sucess (time frame: 12month). 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 31 Jul 2026.