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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04518371
Other study ID # CairoU-EEHussien
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2020
Est. completion date April 28, 2023

Study information

Verified date August 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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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