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

Primary Purpose

Endodontically Treated Teeth

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring Endodontically Treated Teeth, Milled Composite, Clinical Performance, Occlusal Wear, IntraOral Scanner

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indirect Restoration

Direct Restoration

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

The degree of mismatch from the normal range of tooth shades and translucency
Visual inspection to check the proximity of the shade from the natural tooth
The degree of mismatch from the normal range of tooth shades and translucency
Visual inspection to check the proximity of the shade from the natural tooth
The degree of mismatch from the normal range of tooth shades and translucency
Visual inspection to check the proximity of the shade from the natural tooth
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Pain due to dentin hypersensitivity (evaporative stimulus)
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Pain due to dentin hypersensitivity (evaporative stimulus)
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Pain due to dentin hypersensitivity (evaporative stimulus)
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Area of continuous movement of an explorer across the surface of the restoration
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
Area of continuous movement of an explorer across the surface of the restoration
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
Area of continuous movement of an explorer across the surface of the restoration
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
Distance penetrated by the Explorer at the tooth restoration interface
The explorer will be drawn across the surface of the restoration toward the tooth
Distance penetrated by the Explorer at the tooth restoration interface
The explorer will be drawn across the surface of the restoration toward the tooth
Distance penetrated by the Explorer at the tooth restoration interface
The explorer will be drawn across the surface of the restoration toward the tooth

Full Information

First Posted
August 12, 2020
Last Updated
August 19, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04518371
Brief Title
Clinical Performance of Milled Resin Composite in Restoration of Endodontically Treated Posterior Teeth Over One Year
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
April 18, 2022 (Actual)
Study Completion Date
April 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
Keywords
Endodontically Treated Teeth, Milled Composite, Clinical Performance, Occlusal Wear, IntraOral Scanner

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indirect Restoration
Arm Type
Experimental
Arm Description
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).
Arm Title
Direct Restoration
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process.
Other Intervention Name(s)
CAD/CAM Composite endo-crown
Intervention Description
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
Primary Outcome Measure Information:
Title
Degree of Continuity between natural tooth structure and the restoration
Description
Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure
Time Frame
Immediately after procedure
Title
Degree of Continuity between natural tooth structure and the restoration
Description
Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure
Time Frame
6 months
Title
Degree of Continuity between natural tooth structure and the restoration
Description
Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The degree of mismatch from the normal range of tooth shades and translucency
Description
Visual inspection to check the proximity of the shade from the natural tooth
Time Frame
Immediately after procedure
Title
The degree of mismatch from the normal range of tooth shades and translucency
Description
Visual inspection to check the proximity of the shade from the natural tooth
Time Frame
6 months
Title
The degree of mismatch from the normal range of tooth shades and translucency
Description
Visual inspection to check the proximity of the shade from the natural tooth
Time Frame
12 months
Title
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Description
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Time Frame
Immediately after procedure
Title
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Description
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Time Frame
6 months
Title
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Description
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Time Frame
12 months
Title
Pain due to dentin hypersensitivity (evaporative stimulus)
Description
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Time Frame
Immediately after procedure
Title
Pain due to dentin hypersensitivity (evaporative stimulus)
Description
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Time Frame
6 months
Title
Pain due to dentin hypersensitivity (evaporative stimulus)
Description
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Time Frame
12 months
Title
Area of continuous movement of an explorer across the surface of the restoration
Description
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
Time Frame
Immediately after procedure
Title
Area of continuous movement of an explorer across the surface of the restoration
Description
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
Time Frame
6 months
Title
Area of continuous movement of an explorer across the surface of the restoration
Description
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
Time Frame
12 months
Title
Distance penetrated by the Explorer at the tooth restoration interface
Description
The explorer will be drawn across the surface of the restoration toward the tooth
Time Frame
Immediately after procedure
Title
Distance penetrated by the Explorer at the tooth restoration interface
Description
The explorer will be drawn across the surface of the restoration toward the tooth
Time Frame
6 months
Title
Distance penetrated by the Explorer at the tooth restoration interface
Description
The explorer will be drawn across the surface of the restoration toward the tooth
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esraa Es Hussien
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
00202
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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