Wear, OcclusalNCT04839640
Study of Wear in Composite Resin and Reinforced Acrylic Denture Teeth Used in Complete Denture Construction for Completely Edentulous Patients
A study testing Bredent denture teeth in people with Wear, Occlusal, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Wear, Occlusal
- What is being tested?
- Bredent denture teeth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Edentulous subjects with indication for full dentures Skeletal class I maxillomandibular relationship
Who cannot join
- Uncooperative patients. Subjects that wear dentures for less than 6 hours per day Subjects from which no compliance can be expected
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
- Conditions
- Wear, Occlusal
- Being tested
- Bredent denture teeth
- Medical subject headings
- Tooth Attrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bredent denture teethOther
composite resin denture teeth
| Study group | Role | What they receive |
|---|---|---|
| reinforced acrylic resin denture teeth | Active comparator | Shufo acrylic denture teeth Receives: Other: Bredent denture teeth |
| Composite resin denture teeth | Experimental | Bredent denture teeth Receives: Other: Bredent denture teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 May 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wear, OcclusalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split mouth technique
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shereen ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839640
- Sponsor's protocol ID
- 123456789
- Status last verified
- Apr 2021
- First submitted
- 17 Apr 2018
- Last updated
- 9 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04839640
- Acronym / sponsor ID
- 123456789
- Conditions
- Wear, Occlusal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- split mouth technique
| Arm | Type | Receives |
|---|---|---|
| reinforced acrylic resin denture teeth | Active comparator | Other: Bredent denture teethShufo acrylic denture teeth |
| Composite resin denture teeth | Experimental | Other: Bredent denture teethBredent denture teeth |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Edentulous subjects with indication for full dentures Skeletal class I maxillomandibular relationship
Key exclusion criteria (1 listed)
- Uncooperative patients. Subjects that wear dentures for less than 6 hours per day Subjects from which no compliance can be expected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bredent denture teethcomposite resin denture teeth | Other | Composite resin denture teeth, reinforced acrylic resin denture teeth |
Primary outcome
Optical scanning to detect difference in wear at baseline and 3 months follow up visits
Time frame: 3 months
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
Time frame: 6 months
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
Time frame: 9 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bredent denture teeth in people with Wear, Occlusal, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical scanning to detect difference in wear at baseline and 3 months follow up visits (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.