Caries of InfancyNCT06113770
Clinical Evaluation of Polymethyl Methacrylate CAD/CAM Crowns Versus Prefabricated Zirconia Crowns in Primary Molars
A study testing preparation of the tooth to receive ready made zirconia crown and preparation of the tooth to receive CAD CAM PMMA custom made crown in people with Caries of Infancy, run by Adel Sherif Mostafa Rehab at 1 site in Egypt.
Trial summary
, in this studythe investigator will compare between ready-made zirconia crowns and Computer-aided design and Computer-aided manufacturing (CAD/CAM) polymethyl methacrylate (PMMA) crowns to overcome the disadvantages of ready-made zirconia crowns. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries of Infancy
- What is being tested?
- preparation of the tooth to receive ready made zirconia crown and preparation of the tooth to receive CAD CAM PMMA custom made crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to Dec 2023
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
A- Inclusion Criteria:
- Primary molars indicated for crown restoration (pulp treated molars indicated for crown
- Co-operative child (Frankel scale +ve and ++ve)
- The age ranged from 4 to 8 years regardless of sex or socioeconomic background.
B- Exclusion Criteria:-
- Badly decayed non-restorable tooth indicated for extraction.
- Patients with parafunctional habits like bruxism.
- Systemic diseases with oral manifestation or blood diseases.
Trial locations and contacts
1 site in 1 country.
About this study
, in this studythe investigator will compare between ready-made zirconia crowns and Computer-aided design and Computer-aided manufacturing (CAD/CAM) polymethyl methacrylate (PMMA) crowns to overcome the disadvantages of ready-made zirconia crowns.
- Conditions
- Caries of Infancy
- Being tested
- preparation of the tooth to receive ready made zirconia crown, preparation of the tooth to receive CAD CAM PMMA custom made crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preparation of the tooth to receive ready made zirconia crownOther
Occlusal reduction 1 to 2 mm using flame bur . Open the interproximal contacts. The tooth should be reduced circumferentially by approximately 0.5-1.5mm . The preparation margin should be carefully extended and refined to a feather-edge approximately 1-2mm subgingivally .
Crown size will be determined using try in kit .
preparation of the tooth to receive CAD CAM PMMA custom made crownOther
- Open the interproximal contacts .
- The tooth should be reduced circumferentially by approximately 0.5-1mm .
- The preparation margin should be carefully extended and refined to a feather- edge approximately 1-2mm subgingivally .
- Rubber base impression will be taken by BMS additional silicone kit to the prepared tooth and will be sent to the laboratory to be scanned and to design the crown .
- The final crown will be cemented using glass ionomer cement .
| Study group | Role | What they receive |
|---|---|---|
| ready made zirconia | Experimental | the selected tooth will receive ready made zirconia crown Receives: Other: preparation of the tooth to receive ready made zirconia crown |
| pmma crown | Experimental | the selected tooth will receive cad cam custom made pmma crown Receives: Other: preparation of the tooth to receive CAD CAM PMMA custom made crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival condition
Löe \& Silness gingival index
Measured: in 6 months
Secondary outcomes (1)
gingival bleeding
Papilla Bleeding Index
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 posted2 Nov 2023
- Study start1 May 2023
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries of InfancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adel Sherif Mostafa Rehab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adel Sherif Mostafa Rehab, Al-Azhar University
- Investigators
- Adel S Rehab, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113770
- Sponsor's protocol ID
- 787/4375
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Polymethyl Methacrylate CAD/CAM Crowns Versus Prefabricated Zirconia Crowns in Primary Molars
- ClinicalTrials.gov ID
- NCT06113770
- Acronym / sponsor ID
- 787/4375
- Conditions
- Caries of Infancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Adel Sherif Mostafa RehabUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Nov 2023 (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.
, in this studythe investigator will compare between ready-made zirconia crowns and Computer-aided design and Computer-aided manufacturing (CAD/CAM) polymethyl methacrylate (PMMA) crowns to overcome the disadvantages of ready-made zirconia crowns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ready made zirconia | Experimental | Other: preparation of the tooth to receive ready made zirconia crownthe selected tooth will receive ready made zirconia crown |
| pmma crown | Experimental | Other: preparation of the tooth to receive CAD CAM PMMA custom made crownthe selected tooth will receive cad cam custom made pmma crown |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| preparation of the tooth to receive ready made zirconia crownOcclusal reduction 1 to 2 mm using flame bur . Open the interproximal contacts. The tooth should be reduced circumferentially by approximately 0.5-1.5mm . The preparation margin should be carefully extended and refined to a feather-edge approximately 1-2mm subgingivally . Crown size will be determined using try in kit . | Other | ready made zirconia |
| preparation of the tooth to receive CAD CAM PMMA custom made crown* Open the interproximal contacts . * The tooth should be reduced circumferentially by approximately 0.5-1mm . * The preparation margin should be carefully extended and refined to a feather- edge approximately 1-2mm subgingivally . * Rubber base impression will be taken by BMS additional silicone kit to the prepared tooth and will be sent to the laboratory to be scanned and to design the crown . * The final crown will be cemented using glass ionomer cement . | Other | pmma crown |
Primary outcome
Gingival condition
Time frame: in 6 months
Löe \& Silness gingival index
1 secondary outcome
gingival bleeding
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Caries of Infancy
Not yet recruiting
The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries Among Mothers of Infants in Terengganu.
Healthy Women, Caries of Infancy
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.
Adel S Rehab principal investigator
Al-Azhar 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 preparation of the tooth to receive ready made zirconia crown and preparation of the tooth to receive CAD CAM PMMA custom made crown in people with Caries of Infancy, run by Adel Sherif Mostafa Rehab 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?
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: status not confirmed, as of the sponsor's last update on 3 Nov 2023. 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?
Results are not available in the source record.
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 condition (time frame: in 6 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 3 Nov 2023.