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Not yet recruitingNCT07614451Updated May 29, 2026

This Study is Conducted to Evaluate the Clinical Performance of Indirect Overlay Restorations With Different Cavity Preparation Designs in Endodontically Treated Molars.

An interventional study of hybrid ceramic retentive overlay and hybrid ceramic non-retentive overlay in Endodontically Treated Molar, sponsored by Cairo University. Not yet recruiting. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Endodontically Treated Molar

Keywords

  • overlay
  • endodontically treated molars
  • biomimetic preparation
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.

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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    conventional retentive overlay design

    Other: hybrid ceramic retentive overlay

  • Experimental
    minimal invasive non-retentive overlay design

    Other: hybrid ceramic non-retentive overlay

Interventions

  • Otherhybrid ceramic retentive overlay

    Endodontically treated molars will receive indirect overlay restorations utilizing a conventional retentive occlusal box cavity design.

  • Otherhybrid ceramic non-retentive overlay

    Endodontically treated molars will receive indirect overlay restorations utilizing a minimal invasive anatomical non-retentive design.

06

What researchers measure

Primary outcomes

  1. Marginal adaptation (success rate)

    Measuring device: Modified FDI criteria, Measuring unit: Ordinal Data (scores)

    Time frame: 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)

    Time frame: T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07614451
Lead sponsor
Cairo University
Responsible party
Sara Ibrahim Mohamed Fahmy (part-time assistant lecturer, Cairo University) — Principal investigator
First posted
May 29, 2026
Start date
Jun 15, 2026 (estimated)
Primary completion
Jun 15, 2028 (estimated)
Completion
Aug 15, 2028 (estimated)
Last update
May 29, 2026

Study contacts

Sara Ibrahim Fahmy, PhD
Contact
sara.fahmy@dentistry.cu.edu.eg
01006256086 ext. 002
Aya Mohamed Adly, Lecturer
Contact
aya.mohamed@dentistry.cu.edu.eg
Olfat ElSayed Hassanein, Professor
study director · Conservative Dentistry, Faculty of Dentistry, Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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