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OpenTrials
Completed

NCT Number: NCT04518371

Clinical Performance of Milled Resin Composite in Restoration of Endodontically Treated Posterior Teeth Over One Year

In patients with endodontically treated teeth, will the Indirect Milled composite Endo-crown restorations have a better clinical performance and more wear resistance than the Direct Bulk-Fill resin composite restorations over one year?

Primary Objective: To evaluate clinical performance of different Techniques of Composite Restorations (Indirect restorations using a CAD/CAM grinding process, BRILLIANT Crios, Coltène/Whaledent AG, Switzerland or Direct a light-cured, bulk-fill nanocomposite restorative material, Filtek™ One Bulk Fill Restorative, 3M ESPE Dental Products, USA) in Endodontically treated posterior teeth.

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Key information

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 00202, Egypt

About this study

The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Esraa Esmeail Hussien.

Null-hypothesis: There are no differences in the clinical performance of indirect CAD/CAM milled composite when compared to direct bulk-fil composite endocrowns when in the posterior area.

Aim: This clinical trial will be conducted to assess the clinical performance of using indirect Milled composite or direct bulk-fill resin composite Endo-crowns for restoring the endo-treated teeth, as well to measure the amount of wear on the occlusal tables of both restorations using Digital Scanner.

Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University

Clinical Steps:

  • A tapered stone with rounded end in a high-speed handpiece with air /water coolant will be used to properly prepare the cavity walls to receive the indirect restoration and any remaining carious dentin will be excavated and removed.
  • Cuspal tipping will be done by a wheel stone about 1.5-2mm.
  • The entrance to the pulpal canal will be opened. Gutta percha will be removed to a depth not exceeding 2 mm to take advantage of the saddle-like anatomy of the cavity floor. This should be done with a nonabrasive instrument to maintain the integrity of the canal's entrance. No drilling into the dentin will be carried out.
  • Any remaining undercuts will be blocked with conventional resin composite.
  • The impression will be taken, and the final restoration will be fabricated either direct or indirect.
  • The final restoration should be checked intraorally for proximal contacts, occlusion and marginal fit before cementation.
  • Isolation of operatory field using rubber dam.
  • Selective enamel etching technique will be applied for bonding of tooth structure, 35-40% phosphoric acid gel will be applied to the enamel margins only for 15 seconds, rinsed for 15 seconds and gently dried by cotton pellet.
  • Adhesive will be used according to the manufacturers' instructions.
  • Adhesive resin cement will be applied into the preparation. The restoration will be placed in the cavity and checked for complete seating. The cement will be light cured for only 2 seconds to facilitate removal of the excess. Then light curing will be done from all directions each for 40 seconds for achieving the final set.
  • The proximal contacts will be checked with dental floss.
  • The occlusion will be adjusted using articulating paper.
  • Finishing and Polishing using finishing stones and polishing rubber points.

Primary Objective: To evaluate clinical performance of different Techniques of Composite Restorations (Indirect restorations using a CAD/CAM grinding process, BRILLIANT Crios, Coltène/Whaledent AG, Switzerland or Direct a light-cured, bulk-fill nanocomposite restorative material, Filtek™ One Bulk Fill Restorative, 3M ESPE Dental Products, USA) in Endodontically treated posterior teeth.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

of participants:

  • Patients with asymptomatic endodontically treated molars.
  • Males or Females.
  • Good oral hygiene.
  • Co-operative patients approving to participate in the study.

Inclusion criteria

of teeth:

  • Asymptomatic endodontically treated upper or lower molars with
  • Homogenous root canal filling ending 1-2mm from the radiographic apex.
  • Proximal compound cavities.
  • Favorable occlusion.

Exclusion criteria

of participants:

  • High caries index with poor oral hygiene.
  • Severe medical complications.
  • Pregnancy.
  • Allergic history concerning methacrylates Disabilities.
  • Heavy smoking.
  • Xerostomia.
  • Lack of compliance.
  • Evidence of parafunctional habits.
  • Temporomandibular joint disorders.

Exclusion criteria

of the teeth:

  • Teeth with remaining wall thickness less than 1mm.
  • Teeth with improper or symptomatic endodontic treatment.
  • Deep subgingival cavity margins.
  • Possible future prosthodontic restoration of teeth.
  • Severe periodontal problems.

Treatment and study plan

Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process.

Other

Shock-absorbing effect due to the dentine-like modulus of elasticity makes BRILLIANT Crios extremely well suited for implant restorations.it is composed of dental glass (barium glass ˂ 1.0 μm), amorphous silica (Sio2 ˂ 20 nm), resin matrix (cross-linked methacrylates) and pigments

Other names: CAD/CAM Composite endo-crown

Primary outcomes

  1. Degree of Continuity between natural tooth structure and the restoration

    Time frame: Immediately after procedure

    Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure

  2. Degree of Continuity between natural tooth structure and the restoration

    Time frame: 6 months

    Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure

  3. Degree of Continuity between natural tooth structure and the restoration

    Time frame: 12 months

    Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure

Secondary outcomes

  1. The degree of mismatch from the normal range of tooth shades and translucency

    Time frame: Immediately after procedure

    Visual inspection to check the proximity of the shade from the natural tooth

  2. The degree of mismatch from the normal range of tooth shades and translucency

    Time frame: 6 months

    Visual inspection to check the proximity of the shade from the natural tooth

  3. The degree of mismatch from the normal range of tooth shades and translucency

    Time frame: 12 months

    Visual inspection to check the proximity of the shade from the natural tooth

  4. Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins

    Time frame: Immediately after procedure

    Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time

  5. Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins

    Time frame: 6 months

    Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time

  6. Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins

    Time frame: 12 months

    Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time

  7. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: Immediately after procedure

    Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale

  8. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: 6 months

    Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale

  9. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: 12 months

    Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale

  10. Area of continuous movement of an explorer across the surface of the restoration

    Time frame: Immediately after procedure

    Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface

  11. Area of continuous movement of an explorer across the surface of the restoration

    Time frame: 6 months

    Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface

  12. Area of continuous movement of an explorer across the surface of the restoration

    Time frame: 12 months

    Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface

  13. Distance penetrated by the Explorer at the tooth restoration interface

    Time frame: Immediately after procedure

    The explorer will be drawn across the surface of the restoration toward the tooth

  14. Distance penetrated by the Explorer at the tooth restoration interface

    Time frame: 6 months

    The explorer will be drawn across the surface of the restoration toward the tooth

  15. Distance penetrated by the Explorer at the tooth restoration interface

    Time frame: 12 months

    The explorer will be drawn across the surface of the restoration toward the tooth

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Performance and Wear Resistance of Milled Resin Composite Material Versus Direct Nanohybrid Bulk-Fill Resin Composite in Restoration of Endodontically Treated Posterior Teeth Over One Year: Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 19, 2020
Registry last updated
Aug 23, 2023

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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