Endodontically Treated Teeth Clinical Trial
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
Verified date | August 2023 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | April 28, 2023 |
Est. primary completion date | April 18, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | Immediately after procedure | |
Secondary | 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 | 6 months | |
Secondary | 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 | 12 months | |
Secondary | 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 | Immediately after procedure | |
Secondary | 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 | 6 months | |
Secondary | 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 | 12 months | |
Secondary | 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 | Immediately after procedure | |
Secondary | 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 | 6 months | |
Secondary | 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 | 12 months | |
Secondary | 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 | Immediately after procedure | |
Secondary | 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 | 6 months | |
Secondary | 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 | 12 months | |
Secondary | Distance penetrated by the Explorer at the tooth restoration interface | The explorer will be drawn across the surface of the restoration toward the tooth | Immediately after procedure | |
Secondary | Distance penetrated by the Explorer at the tooth restoration interface | The explorer will be drawn across the surface of the restoration toward the tooth | 6 months | |
Secondary | Distance penetrated by the Explorer at the tooth restoration interface | The explorer will be drawn across the surface of the restoration toward the tooth | 12 months |
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