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NCT Number: NCT07614451

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

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

hybrid ceramic retentive overlay

Other

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

hybrid ceramic non-retentive overlay

Other

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

Primary outcomes

  1. 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)

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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Aya Mohamed Adly, Lecturer

CONTACT

[email protected]

Sara Ibrahim Fahmy, PhD

CONTACT

[email protected]

01006256086 ext. 002

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

A Prospective Clinical Evaluation of Indirect Overlay Restorations With Different Cavity Preparation Designs in Endodontically Treated Molars: Two Year Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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