Endodontically Treated MolarNCT06787469
Comparison of the Clinical Performance of High Strength Hybrid Ceramic Indirect Restorations Cemented on Endodontically Treated Teeth Using Bioactive Versus Conventional Self Adhesive Resin Cements.
A study testing Resin Cement in people with Endodontically Treated Molar, run by Cairo University.
Trial summary
Cementation of indirect restoration is a determinant of the success or failure of the fabricated restoration and consequentially the entire tooth. While there are numerous commercially available resin cements in the dental market, not all have been sufficiently assessed with significant follow up periods to clinically… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Endodontically Treated Molar
- What is being tested?
- Resin Cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2025to 1 Jan 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient Related Criteria:
- Adult patients (age: 21-50 years) of both genders.
- Able to tolerate necessary restorative procedures.
- Willing to sign the informed consent.
- Accepts the follow-up period.
- Tooth Related Criteria:
Show all 9Show fewer
- Endodontically treated first and second permanent molars.
- Access cavities with one missing proximal wall i.e. Occluso-mesial/distal cavities
- Patients with proper oral hygiene
Who cannot join
- Endodontically treated anterior, premolar and third molar teeth
- Badly broken-down teeth
- Hopelessly carious/destructed teeth necessitating extraction
- Mobile teeth, indicating periodontal disease or trauma.
- External or internal resorption.
- Cervical carious lesions
- Medically compromised patients
- Patients with known allergies to Latex and/or resinous material
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ahmed N Shalaby, Masters Restorative Dentistry contact
About this study
Official title: Clinical Performance of CAD/CAM Hard Hybrid Ceramic Overlays on Endodontically Treated Molars Using Bioactive Versus Conventional Self-Adhesive Resin Cement: Two-Year Randomized Clinical Trial
Cementation of indirect restoration is a determinant of the success or failure of the fabricated restoration and consequentially the entire tooth. While there are numerous commercially available resin cements in the dental market, not all have been sufficiently assessed with significant follow up periods to clinically determine their success or failure. As such, this research will be conducted to elucidate if there is a viability to the cementation of indirect hybrid ceramic blocks over endodontically treated teeth using bioactive self-adhesive resin cement and determining whether it provides a clinical advantage and improved restoration serviceability in the oral cavity.
- Conditions
- Endodontically Treated Molar
- Being tested
- Resin Cement
- Keywords
- Resin Cement, SHOFU, Bioactive Resin Cement, SPRG, S-PRG, Endodontically treated teeth, BeautiLink SA
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin CementOther
Bioactive self adhesive resin cement (SHOFU BeautiLink) used to cement indirect restorations to endodontically treated molars.
Resin CementOther
Self adhesive resin cement
| Study group | Role | What they receive |
|---|---|---|
| Indirect Restorations cemented using Coltene Solocem Resin Cement | Active comparator | Not described Receives: Other: Resin Cement |
| Indirect Restorations cemented using SHOFU BeautiLink Resin Cement | Active comparator | Not described Receives: Other: Resin Cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified USPHS Criteria
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start23 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated MolarStudies 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
- This study will be conducted on the form of a randomized controlled, unicenter, clustered two-arm superiority trial with a 1:1 allocation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Nabil Hassan Shalaby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787469
- Sponsor's protocol ID
- ANCU-8-1-2025
- Status last verified
- Jun 2025
- First submitted
- 16 Jan 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of CAD/CAM Hard Hybrid Ceramic Overlays on Endodontically Treated Molars Using Bioactive Versus Conventional Self-Adhesive Resin Cement: Two-Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06787469
- Acronym / sponsor ID
- ANCU-8-1-2025
- Conditions
- Endodontically Treated Molar
- Keywords
- Resin Cement, SHOFU, Bioactive Resin Cement, SPRG, S-PRG, Endodontically treated teeth, BeautiLink SA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 22 Jan 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.
Cementation of indirect restoration is a determinant of the success or failure of the fabricated restoration and consequentially the entire tooth. While there are numerous commercially available resin cements in the dental market, not all have been sufficiently assessed with significant follow up periods to clinically determine their success or failure. As such, this research will be conducted to elucidate if there is a viability to the cementation of indirect hybrid ceramic blocks over endodontically treated teeth using bioactive self-adhesive resin cement and determining whether it provides a clinical advantage and improved restoration serviceability in the oral cavity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be conducted on the form of a randomized controlled, unicenter, clustered two-arm superiority trial with a 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Indirect Restorations cemented using Coltene Solocem Resin Cement | Active comparator | Other: Resin Cement |
| Indirect Restorations cemented using SHOFU BeautiLink Resin Cement | Active comparator | Other: Resin Cement |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patient Related Criteria:
- Adult patients (age: 21-50 years) of both genders.
- Able to tolerate necessary restorative procedures.
- Willing to sign the informed consent.
- Accepts the follow-up period.
Key exclusion criteria (8 listed)
- Endodontically treated anterior, premolar and third molar teeth
- Badly broken-down teeth
- Hopelessly carious/destructed teeth necessitating extraction
- Mobile teeth, indicating periodontal disease or trauma.
- External or internal resorption.
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 |
|---|---|---|
| Resin CementBioactive self adhesive resin cement (SHOFU BeautiLink) used to cement indirect restorations to endodontically treated molars. | Other | Indirect Restorations cemented using SHOFU BeautiLink Resin Cement |
| Resin CementSelf adhesive resin cement | Other | Indirect Restorations cemented using Coltene Solocem Resin Cement |
Primary outcome
Modified USPHS Criteria
Time frame: 2 years
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 10 Jun 2025.
- Individual participant dataSharing planned: Yes
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Clinical Performance of Endodontically Treated Teeth Restored With Endocrowns, Restoration Fit of Endodontically Treated Teeth With Endocrowns
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Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth
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This Study is Conducted to Evaluate the Clinical Performance of Indirect Overlay Restorations With Different Cavity Preparation Designs in Endodontically Treated Molars.
Endodontically Treated Molar
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.
Ahmed N Shalaby, Masters Restorative Dentistry contact
Questions about this trial
What is this clinical trial studying?
A study testing Resin Cement in people with Endodontically Treated Molar, 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 9 inclusion and 8 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 10 Jun 2025. 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?
Contact Ahmed N Shalaby, Masters Restorative Dentistry (+201014850792, ahmad.shalaby@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified USPHS Criteria (time frame: 2 years). 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 10 Jun 2025.