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Study of Wear in Composite Resin and Reinforced Acrylic Denture Teeth Used in Complete Denture Construction for Completely Edentulous Patients

Primary Purpose

Wear, Occlusal

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bredent denture teeth
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wear, Occlusal

Eligibility Criteria

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Inclusion Criteria:

Edentulous subjects with indication for full dentures Skeletal class I maxillomandibular relationship

Exclusion Criteria:

Uncooperative patients. Subjects that wear dentures for less than 6 hours per day Subjects from which no compliance can be expected

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

reinforced acrylic resin denture teeth

Composite resin denture teeth

Arm Description

Shufo acrylic denture teeth

Bredent denture teeth

Outcomes

Primary Outcome Measures

Optical scanning to detect difference in wear at baseline and 3 months follow up visits
Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X. The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped to 350 x 400 pixels using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software.
Optical scanning to detect difference in wear at baseline and 6 months follow up visits
Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X. The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped to 350 x 400 pixels using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software.
Optical scanning to detect difference in wear at baseline and 9 months follow up visits
Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X. The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped to 350 x 400 pixels using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2018
Last Updated
April 7, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04839640
Brief Title
Study of Wear in Composite Resin and Reinforced Acrylic Denture Teeth Used in Complete Denture Construction for Completely Edentulous Patients
Official Title
Study of Wear in Composite Resin and Reinforced Acrylic Denture Teeth Used in Complete Denture Construction for Completely Edentulous Patients (Randomized Controlled Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (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

5. Study Description

Brief Summary
Visit 1: Clinical examination and investigations will be carried out for the eligible patients including TMJ examination and intraoral examination for oral mucosa. Diagnostic charts will be prepared with full medical and dental history as well as radiographic records. Primary impression will be performed with irreversible hydro-colloid impression material (alginate), The impressions will be poured with type IV dental stone to obtain diagnostic casts, special tray will be constructed. Visit 2: Maxillary Face-bow will be recorded to mount the upper cast. The diagnostic casts will be mounted on semi adjustable articulator in centric occluding relation to evaluate the inter-arch distance. Visit 3: Secondary impression will be performed in special trays by elastomeric impression material. The impression will be poured into typeIV dental stone in order to obtain master cast. Visit 4: Trial denture base will be constructed and tried in patient's mouth for obtaining maxilla-mandibular relation using face bow record and centric relation record, then mounting of the casts on semi adjustable articulator will be done. The teeth will be set according to the randomization group. Visit 5: The denture bases will be tried in with acrylic teeth in patient's mouth. Visit 6: The denture will be delivered to the patient and occlusal adjustments will be done. Visit 7: Recall visit after one week, further adjustments will be done. The denture will be sent to the scanning center and given to the patient again. Visit 8: At 3 months follow up, the denture will be inspected for calculus and will be immersed in ultrasonic cleaner for 15 seconds to remove calculus and then scanned. Visit 9: At 6 months follow up, the denture will be inspected for calculus and will be immersed in ultrasonic cleaner for 15 seconds to remove calculus and then scanned. Visit 10: At 9 months follow up, the denture will be inspected for calculus and will be immersed in ultrasonic cleaner for 15 seconds to remove calculus and then scanned. The optical methods tend to fulfill the need for quantitative characterization of surface topography. Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X.The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software. Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X. The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped to 350 x 400 pixels using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wear, Occlusal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
split mouth technique
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
reinforced acrylic resin denture teeth
Arm Type
Active Comparator
Arm Description
Shufo acrylic denture teeth
Arm Title
Composite resin denture teeth
Arm Type
Experimental
Arm Description
Bredent denture teeth
Intervention Type
Other
Intervention Name(s)
Bredent denture teeth
Intervention Description
composite resin denture teeth
Primary Outcome Measure Information:
Title
Optical scanning to detect difference in wear at baseline and 3 months follow up visits
Description
Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X. The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped to 350 x 400 pixels using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software.
Time Frame
3 months
Title
Optical scanning to detect difference in wear at baseline and 6 months follow up visits
Description
Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X. The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped to 350 x 400 pixels using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software.
Time Frame
6 months
Title
Optical scanning to detect difference in wear at baseline and 9 months follow up visits
Description
Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X. The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped to 350 x 400 pixels using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software.
Time Frame
9 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Edentulous subjects with indication for full dentures Skeletal class I maxillomandibular relationship Exclusion Criteria: Uncooperative patients. Subjects that wear dentures for less than 6 hours per day Subjects from which no compliance can be expected
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study of Wear in Composite Resin and Reinforced Acrylic Denture Teeth Used in Complete Denture Construction for Completely Edentulous Patients

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