Endodontically Treated MolarNCT07614451
This Study is Conducted to Evaluate the Clinical Performance of Indirect Overlay Restorations With Different Cavity Preparation Designs in Endodontically Treated Molars.
A study testing hybrid ceramic retentive overlay and hybrid ceramic non-retentive overlay in people with Endodontically Treated Molar, run by Cairo University.
Trial summary
This study is conducted to evaluate the clinical performance of indirect overlay restorations with different cavity preparation designs in endodontically treated molars over two years. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Endodontically Treated Molar
- What is being tested?
- hybrid ceramic retentive overlay and hybrid ceramic non-retentive overlay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Aug 2028
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient Related Criteria:
- Adult patients (age: 20-60 years) of both genders.
- Healthy patients (not suffering of any systematic or chronic diseases).
- Able to tolerate the necessary restorative procedures.
- Willing to sign the informed ethical consent.
- Accepts the follow-up period.
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- Tooth Related Criteria:
- Proper endodontically treated teeth.
- First and second permanent molars.
- Absence of any peri-apical lesions.
- Absence of any periodontal disease involvement.
- Large access cavities with one or two missing walls.
- Patients with proper oral hygiene.
- Presence of opposing tooth.
Who cannot join
- Patient related:
- Patients younger than 20 or older than 60 years old.
- Pregnant females.
- Patients with any systemic or chronic diseases.
- Patients not accepting the follow-up period.
- Patients not willing to sign the informed ethical consent.
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- Patients with known allergies to latex and/or resinous material.
- Tooth related
- Endodontically treated anterior, premolar and third molar teeth.
- Hopelessly carious/destructed teeth necessitating extraction.
- Mobile teeth, indicating periodontal disease or trauma.
- External or internal resorption.
- Poor endodontic treatment.
- Periapical lesion present.
- Cervical carious lesions involved.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Aya Mohamed Adly, Lecturer contact
About this study
Official title: A Prospective Clinical Evaluation of Indirect Overlay Restorations With Different Cavity Preparation Designs in Endodontically Treated Molars: Two Year Randomized Clinical Trial
This study is conducted to evaluate the clinical performance of indirect overlay restorations with different cavity preparation designs in endodontically treated molars over two years.
Read the detailed description
First Validation of endodontic treatment using a periapical radiograph and proper history taking.
{I}• Cavity Preparation Procedures for Comparator Group:
- Removal of any remnants of temporary filling and excess gutta percha to the level of root canal orifice.
- Removal of all undermined enamel.
- Then 1.5 to 2 mm cusp reduction will be performed for the buccal and lingual walls.
- The occlusal box will be of 2.5 mm width, 2 mm depth cavity walls and will be flared to produce a 6 degree of divergence.
- The cavity will have internal rounded angles, finished enamel with sharp non-beveled margins and smooth well-defined walls.
- Immediate Dentin Sealing and Cavity Optimization: Immediate dentin sealing will be performed through the use of a universal adhesive followed by the injection of injectable flowable resin composite. Blocking of undercuts using injectable flowable resin composite and margin elevation if required.
- The final retentive design will include occlusal clearance of 2 mm with occlusal box cavity of depth 2 mm with all margins in enamel occlusally and all dentin surfaces will be covered.
{II}• Cavity Preparation Procedures for Intervention Group:
- Removal of any remnants of temporary filling and excess gutta percha to the level of root canal orifice.
- No additional removal of the tooth structure will be performed at this step.
- Cavity optimization will be performed first.
- Blocking of undercuts using injectable flowable resin composite and margin elevation if required.
- The occlusal cavity will be restored during cavity optimization with injectable resin composite to reduce the areas of dentin exposure and preserve the remaining tooth structure.
- The dentin substitute resin composite will establish the biobase.
- An anatomical non retentive preparation design will be performed to show continuous inclined plane preparation with 2 mm cuspal reduction, concave chamfer margins, and 1 to 1.5 mm thick butt-joint preparation in the interproximal portion.
- The final cavity design will include occlusal clearance of 2 mm with total cusp coverage, with biomimetic features (anatomical, non-retentive design) with no occlusal box cavity.
- The CAD/CAM partial coverage overlay restoration will be designed, then milled using SHOFU Hard hybrid ceramic blocks for both groups following its design.
- Cementation for both groups:
- Selective etching of the enamel margins of the cavity will be made using 37% phosphoric acid.
- Application of Universal Adhesive according to manufacturer's instructions and cured.
- Regarding the milled indirect overlay restorations; surface roughening with Dura-Green Stones SHOFU will be performed, followed by the application of a suitable priming agent, then the injection of resin cement in the fitting surface, and finally the restoration will be cemented.
- Restoration will be placed onto the prepared cavities allowing for excess resin cement to emerge which will then be tac-cured for 5 second using a standard intensity light cure allowing for slight hardening of the excess resin cement.
- Removal of excess cement using a sharp explorer, excavator or a c-blade along with the use of interdental flossing to ensure elimination of interdental excess resin cement material.
- Completing the remaining curing cycle after excess removal to the full curing time.
- Conditions
- Endodontically Treated Molar
- Being tested
- hybrid ceramic retentive overlay, hybrid ceramic non-retentive overlay
- Keywords
- overlay, endodontically treated molars, biomimetic preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hybrid ceramic retentive overlayOther
Endodontically treated molars will receive indirect overlay restorations utilizing a conventional retentive occlusal box cavity design.
hybrid ceramic non-retentive overlayOther
Endodontically treated molars will receive indirect overlay restorations utilizing a minimal invasive anatomical non-retentive design.
| Study group | Role | What they receive |
|---|---|---|
| conventional retentive overlay design | Experimental | Not described Receives: Other: hybrid ceramic retentive overlay |
| minimal invasive non-retentive overlay design | Experimental | Not described Receives: Other: hybrid ceramic non-retentive overlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation (success rate)
Measuring device:
Modified FDI criteria,
Measuring unit:
Ordinal Data (scores)
Measured: T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years
Secondary outcomes (1)
proximal contact point 3.fracture of material and retention 4.wear 5. marginal staining 6. color match 7.caries at restoration margin
Measuring device:
Modified FDI criteria,
Measuring unit:
Ordinal Data (scores)
Measured: T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Aug 2028 (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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ibrahim Mohamed Fahmy, Cairo University
- Investigators
- Olfat ElSayed Hassanein, Professor, Study director, Conservative Dentistry, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614451
- Sponsor's protocol ID
- 12041994
- Status last verified
- Apr 2026
- First submitted
- 19 May 2026
- Last updated
- 29 May 2026
- Results posted
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Evaluation of Indirect Overlay Restorations With Different Cavity Preparation Designs in Endodontically Treated Molars: Two Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07614451
- Acronym / sponsor ID
- 12041994
- Conditions
- Endodontically Treated Molar
- Keywords
- overlay, endodontically treated molars, biomimetic preparation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 29 May 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.
This study is conducted to evaluate the clinical performance of indirect overlay restorations with different cavity preparation designs in endodontically treated molars over two years.
Detailed description
First Validation of endodontic treatment using a periapical radiograph and proper history taking.
{I}• Cavity Preparation Procedures for Comparator Group:
- Removal of any remnants of temporary filling and excess gutta percha to the level of root canal orifice.
- Removal of all undermined enamel.
- Then 1.5 to 2 mm cusp reduction will be performed for the buccal and lingual walls.
- The occlusal box will be of 2.5 mm width, 2 mm depth cavity walls and will be flared to produce a 6 degree of divergence.
- The cavity will have internal rounded angles, finished enamel with sharp non-beveled margins and smooth well-defined walls.
- Immediate Dentin Sealing and Cavity Optimization: Immediate dentin sealing will be performed through the use of a universal adhesive followed by the injection of injectable flowable resin composite. Blocking of undercuts using injectable flowable resin composite and margin elevation if required.
- The final retentive design will include occlusal clearance of 2 mm with occlusal box cavity of depth 2 mm with all margins in enamel occlusally and all dentin surfaces will be covered.
{II}• Cavity Preparation Procedures for Intervention Group:
- Removal of any remnants of temporary filling and excess gutta percha to the level of root canal orifice.
- No additional removal of the tooth structure will be performed at this step.
- Cavity optimization will be performed first.
- Blocking of undercuts using injectable flowable resin composite and margin elevation if required.
- The occlusal cavity will be restored during cavity optimization with injectable resin composite to reduce the areas of dentin exposure and preserve the remaining tooth structure.
- The dentin substitute resin composite will establish the biobase.
- An anatomical non retentive preparation design will be performed to show continuous inclined plane preparation with 2 mm cuspal reduction, concave chamfer margins, and 1 to 1.5 mm thick butt-joint preparation in the interproximal portion.
- The final cavity design will include occlusal clearance of 2 mm with total cusp coverage, with biomimetic features (anatomical, non-retentive design) with no occlusal box cavity.
- The CAD/CAM partial coverage overlay restoration will be designed, then milled using SHOFU Hard hybrid ceramic blocks for both groups following its design.
- Cementation for both groups:
- Selective etching of the enamel margins of the cavity will be made using 37% phosphoric acid.
- Application of Universal Adhesive according to manufacturer's instructions and cured.
- Regarding the milled indirect overlay restorations; surface roughening with Dura-Green Stones SHOFU will be performed, followed by the application of a suitable priming agent, then the injection of resin cement in the fitting surface, and finally the restoration will be cemented.
- Restoration will be placed onto the prepared cavities allowing for excess resin cement to emerge which will then be tac-cured for 5 second using a standard intensity light cure allowing for slight hardening of the excess resin cement.
- Removal of excess cement using a sharp explorer, excavator or a c-blade along with the use of interdental flossing to ensure elimination of interdental excess resin cement material.
- Completing the remaining curing cycle after excess removal to the full curing time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional retentive overlay design | Experimental | Other: hybrid ceramic retentive overlay |
| minimal invasive non-retentive overlay design | Experimental | Other: hybrid ceramic non-retentive overlay |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Adult patients (age: 20-60 years) of both genders.
- Healthy patients (not suffering of any systematic or chronic diseases).
- Able to tolerate the necessary restorative procedures.
- Willing to sign the informed ethical consent.
- Accepts the follow-up period.
Key exclusion criteria (15 listed)
- Patient related:
- Patients younger than 20 or older than 60 years old.
- Pregnant females.
- Patients with any systemic or chronic diseases.
- Patients not accepting the follow-up period.
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 |
|---|---|---|
| hybrid ceramic retentive overlayEndodontically treated molars will receive indirect overlay restorations utilizing a conventional retentive occlusal box cavity design. | Other | conventional retentive overlay design |
| hybrid ceramic non-retentive overlayEndodontically treated molars will receive indirect overlay restorations utilizing a minimal invasive anatomical non-retentive design. | Other | minimal invasive non-retentive overlay design |
Primary outcome
Marginal adaptation (success rate)
Time frame: T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years
Measuring device: Modified FDI criteria, Measuring unit: Ordinal Data (scores)
1 secondary outcome
proximal contact point 3.fracture of material and retention 4.wear 5. marginal staining 6. color match 7.caries at restoration margin
Time frame: T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 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 29 May 2026.
- Individual participant dataSharing planned: Yes
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An In-vivo Survival Rate of Different Onlay Materials Placed Over Endodontically Treated Molar Teeth
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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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Milled vs 3D-Printed Partial-Coverage Restorations in Endodontically Treated Molars
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Effect of Different Root Canal Preparation Sizes and Remaining Tooth Structure on the Survival of Endodontically Treated Mandibular Molars
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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.
Aya Mohamed Adly, Lecturer contact
Olfat ElSayed Hassanein, Professor study director
Conservative Dentistry, Faculty of Dentistry, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing hybrid ceramic retentive overlay and hybrid ceramic non-retentive overlay 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 14 inclusion and 15 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 29 May 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?
Contact Sara Ibrahim Fahmy, PhD (01006256086 ext. 002, sara.fahmy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal adaptation (success rate) (time frame: T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 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 29 May 2026.