Edentulous MouthNCT03675594
Retention of Computer Aided Design and Computer Aided Manufacturing Titanium Versus Co/Cr Single Dentures.
A study testing CAD/CAM titanium denture base and CAD/CAM cobalt/chromium denture bases in people with Edentulous Mouth, run by Cairo University at 1 site in Egypt.
Trial summary
Steps in short: Undergoing the conventional steps of maxillary single denture construction till the step of framework construction that will be designed and constructed using CAD/CAM after optical scanning of the master cast ( 2 frameworks to cover the palate and crest of the ridge : one made of titanium and the other… Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Mouth
- What is being tested?
- CAD/CAM titanium denture base and CAD/CAM cobalt/chromium denture bases
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 30 Sep 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 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completely edentulous maxillary arch and fully dentate mandibular arch with adequate interarch space.
- The edentulous ridges should be covered by firm healthy mucosa.
- Angle class I maxillomandibular relationship
- Healthy and co-operative patients.
Who cannot join
- Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than I 0 cigarettes/day).
- Previous history of radiotherapy or chemotherapy.
- Any skeletal problem dictates surgical intervention.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine
Cairo, Manyal, 12554
atef shaker, dean, (+202) 23642938, dean@dentistry.cu.edu.eg
About this study
Official title: Retention of Computer Aided Design and Computer Aided Manufacturing Titanium Versus Cobalt/Chromium Maxillary Single Denture Bases: A Randomized Clinical Trial.
- Steps in short: Undergoing the conventional steps of maxillary single denture construction till the step of framework construction that will be designed and constructed using CAD/CAM after optical scanning of the master cast ( 2 frameworks to cover the palate and crest of the ridge : one made of titanium and the other made of cobalt/chromium) then conventional steps will be undergone including bite, Try-in and delivery ending by measuring the denture retention.
- Number of visits \& follow up period :
Visits: will be 5-6 visits for each patient. Follow up period: 6.5 months (immediately post-insertion then after 1 week then after 3 months for the first type then 2 weeks washout period and the same for the second type)
Read the detailed description
The study will be carried out in the department of prosthodontics-cairo university. Patients will be selected from the out-patient clinic according to the inclusion criteria, The primary impression will be made with alginate (cavex-normal set) and will be border-molded to get the acceptable extension and border thickness, a tray will be prepared with self-activated acrylic resin over the study cast. A secondary impression will be made with heavy putty consistency as a border molding material and the final impression will be made with light rubber base (3M) impression material, Then Pouring of the final impressions with type 4 Hydrocal dental stone (Hydrocal Dental stone, Bayer, and Germany). Master casts will be optically scanned using 3 shape optical scanner. Duplication of master casts will be done using silicone duplicating material. Titanium and cobalt/chromium metallic bases will be milled using 3shape milling machine to cover the palate with mesh extension over the ridge. They will be tried intra-orally regarding sitting and stability. Occlusal rim will be set on titanium metallic base then face bow record will be recorded then mounting the maxillary master cast. Centric relation will be registered then mounting of the mandibular cast will be done. The same will be done for the duplicate cast with the Cobalt/Chromium metallic base. Then Setting of the anatomical teeth for both master casts then try-in stage will be checked intra-orally then packing of cast and duplicate cast with conventional heat cured acrylic resin (Dentsply, Dentsply limited, Weybridge, Surrey. England) after flasking each denture will be finished.
The dentures will be delivered, then the assessment will be immediately and after 1 week then after 3 months that a hook screw with its nut (Digital force gauge instrument, model 475044) will be secured in the polished mid-palatal surface of the upper denture using metallic adhesive to record the amount of the force required for dislodgment. The pull end of the digital force gauge device will be connected to the hook positioned at maxillary dentures for one type of the two dentures and will be pulled vertically until denture dislodgement occurred, then the patient will take off his first type of denture for 2 weeks as a washout period then the second type of denture will be delivered and the same assessment will be done.
- Conditions
- Edentulous Mouth
- Being tested
- CAD/CAM titanium denture base, CAD/CAM cobalt/chromium denture bases
- Keywords
- Dislodgement force, Digital denture, CAD/CAM metallic dentures
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM titanium denture baseDevice
metallic denture base made of titanium
CAD/CAM cobalt/chromium denture basesDevice
metallic denture bases made of cobalt/chromium
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | the group of participants will take the CAD/CAM titanium denture bases and assessment during and after the first 3 months after delivery of the first type. Receives: Device: CAD/CAM titanium denture base |
| intervention arm 2 | Experimental | the same group of participants will take the CAD/CAM cobalt/chromium denture bases and assessment during and after the second 3 months after delivery of the second type. Receives: Device: CAD/CAM cobalt/chromium denture bases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of single denture
the dislodgement force of the denture will be assessed
Measured: 6.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MouthStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Gamal Ismail Mohamed, Cairo University
- Investigators
- iman rady, professor, Study director, head of evidence based dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675594
- Sponsor's protocol ID
- 28912240102212
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it will not be shared with other researchers except my supervisor
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention of Computer Aided Design and Computer Aided Manufacturing Titanium Versus Cobalt/Chromium Maxillary Single Denture Bases: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03675594
- Acronym / sponsor ID
- 28912240102212
- Conditions
- Edentulous Mouth
- Keywords
- Dislodgement force, Digital denture, CAD/CAM metallic dentures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 18 Sep 2018 (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.
- Steps in short: Undergoing the conventional steps of maxillary single denture construction till the step of framework construction that will be designed and constructed using CAD/CAM after optical scanning of the master cast ( 2 frameworks to cover the palate and crest of the ridge : one made of titanium and the other made of cobalt/chromium) then conventional steps will be undergone including bite, Try-in and delivery ending by measuring the denture retention.
- Number of visits \& follow up period :
Visits: will be 5-6 visits for each patient. Follow up period: 6.5 months (immediately post-insertion then after 1 week then after 3 months for the first type then 2 weeks washout period and the same for the second type)
Detailed description
The study will be carried out in the department of prosthodontics-cairo university. Patients will be selected from the out-patient clinic according to the inclusion criteria, The primary impression will be made with alginate (cavex-normal set) and will be border-molded to get the acceptable extension and border thickness, a tray will be prepared with self-activated acrylic resin over the study cast. A secondary impression will be made with heavy putty consistency as a border molding material and the final impression will be made with light rubber base (3M) impression material, Then Pouring of the final impressions with type 4 Hydrocal dental stone (Hydrocal Dental stone, Bayer, and Germany). Master casts will be optically scanned using 3 shape optical scanner. Duplication of master casts will be done using silicone duplicating material. Titanium and cobalt/chromium metallic bases will be milled using 3shape milling machine to cover the palate with mesh extension over the ridge. They will be tried intra-orally regarding sitting and stability. Occlusal rim will be set on titanium metallic base then face bow record will be recorded then mounting the maxillary master cast. Centric relation will be registered then mounting of the mandibular cast will be done. The same will be done for the duplicate cast with the Cobalt/Chromium metallic base. Then Setting of the anatomical teeth for both master casts then try-in stage will be checked intra-orally then packing of cast and duplicate cast with conventional heat cured acrylic resin (Dentsply, Dentsply limited, Weybridge, Surrey. England) after flasking each denture will be finished.
The dentures will be delivered, then the assessment will be immediately and after 1 week then after 3 months that a hook screw with its nut (Digital force gauge instrument, model 475044) will be secured in the polished mid-palatal surface of the upper denture using metallic adhesive to record the amount of the force required for dislodgment. The pull end of the digital force gauge device will be connected to the hook positioned at maxillary dentures for one type of the two dentures and will be pulled vertically until denture dislodgement occurred, then the patient will take off his first type of denture for 2 weeks as a washout period then the second type of denture will be delivered and the same assessment will be done.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Device: CAD/CAM titanium denture basethe group of participants will take the CAD/CAM titanium denture bases and assessment during and after the first 3 months after delivery of the first type. |
| intervention arm 2 | Experimental | Device: CAD/CAM cobalt/chromium denture basesthe same group of participants will take the CAD/CAM cobalt/chromium denture bases and assessment during and after the second 3 months after delivery of the second type. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Completely edentulous maxillary arch and fully dentate mandibular arch with adequate interarch space.
- The edentulous ridges should be covered by firm healthy mucosa.
- Angle class I maxillomandibular relationship
- Healthy and co-operative patients.
Key exclusion criteria (3 listed)
- Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than I 0 cigarettes/day).
- Previous history of radiotherapy or chemotherapy.
- Any skeletal problem dictates surgical intervention.
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 |
|---|---|---|
| CAD/CAM titanium denture basemetallic denture base made of titanium | Device | intervention arm |
| CAD/CAM cobalt/chromium denture basesmetallic denture bases made of cobalt/chromium | Device | intervention arm 2 |
Primary outcome
Retention of single denture
Time frame: 6.5 months
the dislodgement force of the denture will be assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Individual participant dataSharing planned: No. it will not be shared with other researchers except my supervisor
Related trials for Edentulous Mouth
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Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
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Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
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Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
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Not yet recruitingObservational study
Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
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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.
iman rady, professor study director
head of evidence based dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM titanium denture base and CAD/CAM cobalt/chromium denture bases in people with Edentulous Mouth, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amal el rekaby, professor (0122258794, prosthetic@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of single denture (time frame: 6.5 months). 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 19 Sep 2018.