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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.
Show all 15Show fewer
  • 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

aya.mohamed@dentistry.cu.edu.eg

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.
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 groups in NCT07614451
Study groupRoleWhat they receive
conventional retentive overlay designExperimentalNot described
Receives: Other: hybrid ceramic retentive overlay
minimal invasive non-retentive overlay designExperimentalNot 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.

  1. 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)
  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.

  1. First posted29 May 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion15 Jun 2028 (estimated)
  4. Study completion15 Aug 2028 (estimated)

Resources

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)
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

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.

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