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CompletedNCT04839640Updated Apr 9, 2021

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

An interventional study of Bredent denture teeth in Wear, Occlusal, sponsored by Cairo University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2021-04-09.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Wear, Occlusal
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
6 participants (actual)

Study arms

  • Active comparator
    reinforced acrylic resin denture teeth

    Shufo acrylic denture teeth

    Other: Bredent denture teeth

  • Experimental
    Composite resin denture teeth

    Bredent denture teeth

    Other: Bredent denture teeth

Interventions

  • OtherBredent denture teeth

    composite resin denture teeth

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 9 months

06

Study locations

1 site
  • Cairo University
    Cairo, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04839640
Lead sponsor
Cairo University
Responsible party
shereen ismail (principle investigator, Cairo University) — Principal investigator
First posted
Apr 9, 2021
Start date
May 1, 2018
Primary completion
May 1, 2019
Completion
May 1, 2019
Last update
Apr 9, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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