Endocrown RestorationNCT07005167
Clinical Performance of Endocrowns Fabricated From Two Hybrid Ceramic Materials on Endodontically Treated Molars: A Randomized Clinical Trial
A study testing endocrowns in people with Endocrown Restoration, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this study is to evaluate the clinical success rate (measured by retention) of endo-crowns fabricated from two hybrid ceramic materials (HC Hard blocks ) versus (Cerasmart) at 6, 12, and 18 months. Secondary Objectives are: 1. To compare the incidence of restoration failures between the two materials 2. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Endocrown Restoration
- What is being tested?
- endocrowns
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2025to Dec 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥21 years
- Good general health (ASA I or II)
- Willing and able to provide informed consent
- Committed to follow-up appointments for 18 months
- Root canal treated molars requiring restoration
- Adequate remaining tooth structure:
Show all 16Show fewer
- Minimum 2mm ferrule height
- Sufficient wall thickness (≥1.5mm)
- At least 2 remaining walls
- Opposing natural dentition or fixed prosthesis
- Adequate periodontal health:
- Probing depth ≤4mm
- No bleeding on probing
- Good oral hygiene with plaque score ≤20%
- Sufficient mouth opening for clinical procedures
- Normal occlusion and acceptable interocclusal space
Who cannot join
- Pregnant or lactating women
- Severe bruxism or parafunctional habits
- Active periodontal disease
- Active caries or inadequate oral hygiene
- Less than 2mm ferrule height after preparation
- Apical pathology or inadequate root canal treatment
Show all 16Show fewer
- Tooth mobility grade II or III
- Known allergy to materials used
- Uncontrolled diabetes (HbA1c >7.0%)
- Radiation therapy in head and neck region
- Temporomandibular joint disorders
- History of poor compliance with dental appointments
- Heavy smokers (>10 cigarettes/day)
- Chronic use of medications affecting salivary flow
- Unable to understand study requirements
- Evidence of pulpal or periapical pathology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Omnia Omnia Nabil, Lecturer Fixed Prosthodontics contact
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo
Faculty of dentistry, cairo university, +223642705 ext. 543, rec@dentistry.cu.edu.eg
About this study
The goal of this study is to evaluate the clinical success rate (measured by retention) of endo-crowns fabricated from two hybrid ceramic materials (HC Hard blocks ) versus (Cerasmart) at 6, 12, and 18 months.
Secondary Objectives are:
- To compare the incidence of restoration failures between the two materials
- To assess marginal adaptation and marginal discoloration over time
- To evaluate wear of opposing enamel quantitatively
- To compare surface texture, color match, and luster between materials
- To determine patient satisfaction with both types of restorations It will be a randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.
- Conditions
- Endocrown Restoration
- Being tested
- endocrowns
- Keywords
- Hybrid ceramics, cerasmart, HC hard blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endocrownsProcedure or surgery
endocrowns made of HC hard blocks or cerasmart blocks to restore endo treated molars
endocrownsProcedure or surgery
endocrowns made of Cerasmart blocks to restore endo treated molars
| Study group | Role | What they receive |
|---|---|---|
| Outpatients with endo-treated molars that will be restored with HC hard hybrid ceramic endocrowns | Experimental | Not described Receives: Procedure: endocrowns |
| utpatients with endo-treated molars that will be restored with Cerasmart endocrowns | Active comparator | Not described Receives: Procedure: endocrowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Modified USPHS criteria
Measured: From cementation of endocrown, then at 6 months, 12 months and 18 months
Secondary outcomes (7)
Restoration Failure
Modified USPHS criteria
Measured: From cementation of endocrown, then at 6 months, 12 months and 18 months
Marginal Adaptation
Modified USPHS criteria
Measured: From cementation of endocrown, then at 6 months, 12 months and 18 months
Wear of Opposing Enamel
Digital software (Geomagic)
Measured: From cementation of endocrown, then at 6 months, 12 months and 18 months
Surface Texture
Modified USPHS criteria
Measured: From cementation of endocrown, then at 6 months, 12 months and 18 months
Color Match
Modified USPHS criteria
Measured: From cementation of endocrown, then at 6 months, 12 months and 18 months
Luster of Restoration
Modified USPHS criteria
Measured: From cementation, then at 6 months, 12 months and 18 months
Patient Satisfaction
VAS (Questionnaire)
Measured: From cementation, then at 6 months, 12 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrown RestorationStudies 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
- Model description
- Randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Ahmed Farid Zaki Shehab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005167
- Sponsor's protocol ID
- 240789
- Other IDs
- Shofu Inc,
- Status last verified
- May 2025
- First submitted
- 3 Jun 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Endocrowns Fabricated From Two Hybrid Ceramic Materials on Endodontically Treated Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07005167
- Acronym / sponsor ID
- 240789
- Conditions
- Endocrown Restoration
- Keywords
- Hybrid ceramics, cerasmart, HC hard blocks
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Jun 2025 (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.
The goal of this study is to evaluate the clinical success rate (measured by retention) of endo-crowns fabricated from two hybrid ceramic materials (HC Hard blocks ) versus (Cerasmart) at 6, 12, and 18 months.
Secondary Objectives are:
- To compare the incidence of restoration failures between the two materials
- To assess marginal adaptation and marginal discoloration over time
- To evaluate wear of opposing enamel quantitatively
- To compare surface texture, color match, and luster between materials
- To determine patient satisfaction with both types of restorations It will be a randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Outpatients with endo-treated molars that will be restored with HC hard hybrid ceramic endocrowns | Experimental | Procedure: endocrowns |
| utpatients with endo-treated molars that will be restored with Cerasmart endocrowns | Active comparator | Procedure: endocrowns |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥21 years
- Good general health (ASA I or II)
- Willing and able to provide informed consent
- Committed to follow-up appointments for 18 months
- Root canal treated molars requiring restoration
Key exclusion criteria (16 listed)
- Pregnant or lactating women
- Severe bruxism or parafunctional habits
- Active periodontal disease
- Active caries or inadequate oral hygiene
- Less than 2mm ferrule height after preparation
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 |
|---|---|---|
| endocrownsendocrowns made of HC hard blocks or cerasmart blocks to restore endo treated molars | Procedure or surgery | Outpatients with endo-treated molars that will be restored with HC hard hybrid ceramic endocrowns |
| endocrownsendocrowns made of Cerasmart blocks to restore endo treated molars | Procedure or surgery | utpatients with endo-treated molars that will be restored with Cerasmart endocrowns |
Primary outcome
Retention
Time frame: From cementation of endocrown, then at 6 months, 12 months and 18 months
Modified USPHS criteria
7 secondary outcomes
Restoration Failure
Time frame: From cementation of endocrown, then at 6 months, 12 months and 18 months
Marginal Adaptation
Time frame: From cementation of endocrown, then at 6 months, 12 months and 18 months
Wear of Opposing Enamel
Time frame: From cementation of endocrown, then at 6 months, 12 months and 18 months
Surface Texture
Time frame: From cementation of endocrown, then at 6 months, 12 months and 18 months
Color Match
Time frame: From cementation of endocrown, then at 6 months, 12 months and 18 months
Luster of Restoration
Time frame: From cementation, then at 6 months, 12 months and 18 months
Patient Satisfaction
Time frame: From cementation, then at 6 months, 12 months and 18 months
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 5 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Endocrown Restoration
Active, not recruiting
Clinical Comparison of Lithium Disilicate and 3D-Printed Resin Endocrowns
Endodontically Treated Teeth, Nonvital Teeth
Not yet recruiting
Clinical Performance and Fit of 3D-Printed Versus Milled Endocrowns: An 18-Month Trial
Clinical Performance of Endodontically Treated Teeth Restored With Endocrowns, Restoration Fit of Endodontically Treated Teeth With Endocrowns
Active, not recruiting
Deep Margin Elevation in Endodontically Treated Posterior Teeth
Periodontal Health, Endodontically Treated Teeth
Not yet recruiting
Additive vs Subtractive Manufacturing for Endocrown Fabrication: A 24-Month RCT
Tooth, Nonvital, Dental Restoration
Recruiting
Clinical Trial of Modified Endocrown and Personalized Post-core and Crown for Large-area Tooth Defects After Root Canal Treatment
Root Canal Infection, Tooth Defect
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.
Omnia Omnia Nabil, Lecturer Fixed Prosthodontics contact
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 Endocrown Restoration, run by Cairo 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 16 inclusion and 16 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 5 Jun 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?
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?
Contact Nada Farid Nada Farid Shehab, PhD (+201223402909, nada.farid@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: From cementation of endocrown, then at 6 months, 12 months and 18 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 5 Jun 2025.