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

NCT04518371 | Completed DMC

• 1 other identifier: CairoU-EEHussien
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endodontically Treated Teeth

Keywords

Endodontically Treated Teeth; Milled Composite; Clinical Performance; Occlusal Wear; IntraOral Scanner

Outcome Measures

Primary Outcomes (3)

• Degree of Continuity between natural tooth structure and the restoration

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

  Immediately after procedure

• Degree of Continuity between natural tooth structure and the restoration

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

  6 months

• Degree of Continuity between natural tooth structure and the restoration

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

  12 months

Secondary Outcomes (15)

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

  Immediately after procedure

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

  6 months

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

  12 months

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

  Immediately after procedure

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

  6 months

Study Arms (2)

Indirect Restoration

EXPERIMENTAL

Milled Resin Composite Block, 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 (inorganic pigments such as ferrous oxide or titanium dioxide).

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

Direct Restoration

ACTIVE COMPARATOR

3M™ Filtek™ One Bulk Fill Restorative is a visible light activated, restorative composite optimized to create fast and easy restorations. It is composed of fillers which are a combination of a non-agglomerated/non-aggregated 20 nm silica filler, 4 to 11 nm zirconia filler, zirconia/silica cluster filler and ytterbium trifluoride filler consisting of 100nm particles. The inorganic filler loading is about 76.5% by weight (58.5% by volume).

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

Interventions

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

Also known as: CAD/CAM Composite endo-crown

Direct Restoration; Indirect Restoration

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with asymptomatic endodontically treated molars.
• Males or Females.
• Good oral hygiene.
• Co-operative patients approving to participate in the study.
• Asymptomatic endodontically treated upper or lower molars with
• Homogenous root canal filling ending 1-2mm from the radiographic apex.
• Proximal compound cavities.
• Favorable occlusion.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 00202, Egypt

Location

MeSH Terms

Conditions

Tooth, Nonvital; Tooth Attrition

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Study Officials

• Esraa Es Hussien

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 19, 2020
• Study Start: October 22, 2020
• Primary Completion: April 18, 2022
• Study Completion: April 28, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

EG (1)