PaediatricNCT04073901
Comparative Study Between Zirconia Crowns and Endocrowns in Pulpotomized Primary Molars
A study testing Endocrowns in people with Paediatric and Dentistry, run by Nahda University at 1 site in Egypt.
Trial summary
Objectives: The new approach of pediatric esthetic dentistry intended to achieve a healthy beautiful smile rather than achieving only a beautiful smile. The objective of this study was to assess the clinical performance of ceramic Endocrowns and Zirconia crowns for the restoration of pulpotomized primary molars and… Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Paediatric, Dentistry
- What is being tested?
- Endocrowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2018to 30 Jul 2019
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- . Free of systemic diseases.
- Age between 4 and 7 years.
- Takes no medication on regular basis.
- Has bilateral lower second primary molar with deep carious lesion, indicated for pulp therapy and crown restoration. (split mouth)
- Patient and parent compliance.
Who cannot join
- 1. Non-restorable tooth. 2. Tooth near its exfoliation. 3. Tooth with extensive root resorption or periapical pathosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Endocrowns Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars : A Pilot Prospective Clinical Study
Objectives: The new approach of pediatric esthetic dentistry intended to achieve a healthy beautiful smile rather than achieving only a beautiful smile. The objective of this study was to assess the clinical performance of ceramic Endocrowns and Zirconia crowns for the restoration of pulpotomized primary molars and parental satisfaction toward these crowns. Study design: Randomized clinical trial/split mouth design compared the clinical outcomes of two coronal restorations, on patients with bilateral carious second primary molars restoring one side with Endocrown (IPS e.max Press) and the other side with zirconia crown. Children attended Nahda University; Faculty of Dentistry clinics who need restorations screened for inclusion criteria till 20 patients are recruited (20 teeth for zirconia crown restorations and 20 for Endocrowns restorations). All children fulfilled the inclusion criteria were evaluated for factors including restoration integrity, marginal adaptation, marginal discoloration, oral health and overall clinical success at 3,6,12 months while parental satisfaction at 12 months follow up..
- Conditions
- Paediatric, Dentistry
- Being tested
- Endocrowns
- Keywords
- Aesthetic, Endo-crowns, primary, molars, pulpotomy, zirconium, crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndocrownsOther
Adhesive monoblock restoration for pulpotomized primary molars
| Study group | Role | What they receive |
|---|---|---|
| Endocrown | Experimental | Adhesive monoblock restoration for pulpotomized primary molars Receives: Other: Endocrowns |
| Zirconia crowns | Active comparator | Prefabricated primary full coverage crown Receives: Other: Endocrowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration integrity
Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)
Measured: one year
marginal adaptation
Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)
Measured: one year
marginal discoloration
Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)
Measured: one year
Secondary outcomes (1)
parent satisfaction
5-point Likert scale Likert scale(0-4)
Measured: immediate after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start2 Feb 2018
- Primary completion3 Jun 2018
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PaediatricStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nahda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yassmine mohamed farouk el makawi, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073901
- Sponsor's protocol ID
- 186
- Status last verified
- Apr 2020
- First submitted
- 22 Aug 2019
- Last updated
- 22 Apr 2020
- Results posted
- No
- 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 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Endocrowns Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars : A Pilot Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04073901
- Acronym / sponsor ID
- 186
- Conditions
- Paediatric, Dentistry
- Keywords
- Aesthetic, Endo-crowns, primary, molars, pulpotomy, zirconium, crowns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nahda UniversityUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 3 Jun 2018 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 29 Aug 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.
Objectives: The new approach of pediatric esthetic dentistry intended to achieve a healthy beautiful smile rather than achieving only a beautiful smile. The objective of this study was to assess the clinical performance of ceramic Endocrowns and Zirconia crowns for the restoration of pulpotomized primary molars and parental satisfaction toward these crowns. Study design: Randomized clinical trial/split mouth design compared the clinical outcomes of two coronal restorations, on patients with bilateral carious second primary molars restoring one side with Endocrown (IPS e.max Press) and the other side with zirconia crown. Children attended Nahda University; Faculty of Dentistry clinics who need restorations screened for inclusion criteria till 20 patients are recruited (20 teeth for zirconia crown restorations and 20 for Endocrowns restorations). All children fulfilled the inclusion criteria were evaluated for factors including restoration integrity, marginal adaptation, marginal discoloration, oral health and overall clinical success at 3,6,12 months while parental satisfaction at 12 months follow up..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocrown | Experimental | Other: EndocrownsAdhesive monoblock restoration for pulpotomized primary molars |
| Zirconia crowns | Active comparator | Other: EndocrownsPrefabricated primary full coverage crown |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- . Free of systemic diseases.
- Age between 4 and 7 years.
- Takes no medication on regular basis.
- Has bilateral lower second primary molar with deep carious lesion, indicated for pulp therapy and crown restoration. (split mouth)
- Patient and parent compliance.
Key exclusion criteria (1 listed)
- 1. Non-restorable tooth. 2. Tooth near its exfoliation. 3. Tooth with extensive root resorption or periapical pathosis.
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 |
|---|---|---|
| EndocrownsAdhesive monoblock restoration for pulpotomized primary molars | Other | Endocrown, Zirconia crowns |
Primary outcome
Restoration integrity
Time frame: one year
Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)
marginal adaptation
Time frame: one year
Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)
marginal discoloration
Time frame: one year
Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)
1 secondary outcome
parent satisfaction
Time frame: immediate after intervention
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 22 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Paediatric
Not yet recruitingPhase 3
Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy
Cerebral Palsy, Hip Surgery Corrective
Recruiting
Development of a Digital Personalised Nutrition Tool for Adolescents Undergoing Cancer Treatment
Paediatric Oncology, Malnutrition in Children
Enrolling by invitationObservational study
The Development of Paediatric Bronchiectasis Quality of Life Questionnaires for Four Demographic Groups: Children 8-12years, Young People 13 - 17 Years and Parent Proxy Versions for Ages 2-5years and 6-12years
Paediatric Bronchiectasis
Not yet recruitingObservational study
MEMRI: Memory Emergence Using MRI
Not Applicable - Healthy Participants, Focus is the Memory System
Enrolling by invitation
Innovative Probe With Laser on Radial Artery Puncture and Catheterisation in Paediatric
Radial Artery Catheterization, Paediatric
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 Endocrowns in people with Paediatric and Dentistry, run by Nahda 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 5 inclusion and 1 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 22 Apr 2020. 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?
Restoration integrity (time frame: one year). The study lists 3 primary outcomes in all. 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 22 Apr 2020; AzTrials last refreshed its copy on 5 Nov 2026.