Mandibular Prosthesis UserNCT03777423
Comparison Between Injection Molded PEEK Framework and Cobalt Chromium Framework Removable Partial Dentures Regarding Biting Force
A study testing PEEK framework partial dentures and Cobalt- chromium framework partial dentures in people with Mandibular Prosthesis User, run by Cairo University at 1 site in Egypt.
Trial summary
This study is aiming to evaluate the biting force of polyetheretherketone (PEEK) framework partial dentures compared to that of cobalt-chromium ones in mandibular Kennedy class I edentulous cases hoping that polyetheretherketone (PEEK) framework removable partial dentures can improve the patient masticatory efficiency… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandibular Prosthesis User
- What is being tested?
- PEEK framework partial dentures and Cobalt- chromium framework partial dentures
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jul 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Kennedy class 1 partially edentulous subjects indicated for framework partial denture
Who cannot join
- Uncooperative patients
- Bad oral hygiene patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of oral and dental medincine Cairo university
Cairo, 11311
Hassan Ahmed
About this study
Official title: Evaluation of Biting Force of Removable Partial Denture Made of Injection Molded PEEK Framework Versus Cobalt Chromium Framework in Mandibular Kennedy Class I Edentulous Cases
This study is aiming to evaluate the biting force of polyetheretherketone (PEEK) framework partial dentures compared to that of cobalt-chromium ones in mandibular Kennedy class I edentulous cases hoping that polyetheretherketone (PEEK) framework removable partial dentures can improve the patient masticatory efficiency .
- Conditions
- Mandibular Prosthesis User
- Being tested
- PEEK framework partial dentures, Cobalt- chromium framework partial dentures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK framework partial denturesDevice
Polymer-based framework recently introduced made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.
Cobalt- chromium framework partial denturesDevice
It's a bio-compatible metal used in thin sections so less bulky, provide high strength and stiffness ,conduct heat and cold for a more natural experience, enable designs that minimize the covering of the gingival margins, allow for a stable denture base, and resistance to corrosion.Drawbacks of metal frameworks can include hypersensitivity, aesthetics because of metal metal display, oral galvanism, adverse tissue reactions, osteolysis of abutment teeth, and biofilm production
| Study group | Role | What they receive |
|---|---|---|
| PEEK framework partial dentures | Experimental | High performance ketone polymers introduced lately.These polymer-based frameworks provide better esthetics, higher elasticity, lighter in weight, have low water sorption and solubility, and are easily repaired and reproduced. Receives: Device: PEEK framework partial dentures |
| Cobalt-chromium framework partial dentures | Active comparator | it is considered the gold standard framework. These frameworks are less bulky with high strength, conduct heat and electricity well, and have good durability. some disadvantages include hypersensitivity, adverse tissue reactions and bad aesthetics. Receives: Device: Cobalt- chromium framework partial dentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biting force
Biting force of the patient wearing the removable partial denture measured by I-load sensor device.
Measured: Change in baseline biting force from time of insertion, insertion after 1 month and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandibular Prosthesis UserStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Hatim Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777423
- Sponsor's protocol ID
- CEBD-CU-2018-11-29
- Status last verified
- Dec 2018
- First submitted
- 11 Dec 2018
- Last updated
- 17 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Jammali ZM. Clinical Evaluation of Maximum Bite Force in Patient with Heat Cure acrylic and Flexible Partial Dentures. Medical Journal of Babylon. 2017;14(3):509-17.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biting Force of Removable Partial Denture Made of Injection Molded PEEK Framework Versus Cobalt Chromium Framework in Mandibular Kennedy Class I Edentulous Cases
- ClinicalTrials.gov ID
- NCT03777423
- Acronym / sponsor ID
- CEBD-CU-2018-11-29
- Conditions
- Mandibular Prosthesis User
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 17 Dec 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.
This study is aiming to evaluate the biting force of polyetheretherketone (PEEK) framework partial dentures compared to that of cobalt-chromium ones in mandibular Kennedy class I edentulous cases hoping that polyetheretherketone (PEEK) framework removable partial dentures can improve the patient masticatory efficiency .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK framework partial dentures | Experimental | Device: PEEK framework partial denturesHigh performance ketone polymers introduced lately.These polymer-based frameworks provide better esthetics, higher elasticity, lighter in weight, have low water sorption and solubility, and are easily repaired and reproduced. |
| Cobalt-chromium framework partial dentures | Active comparator | Device: Cobalt- chromium framework partial denturesit is considered the gold standard framework. These frameworks are less bulky with high strength, conduct heat and electricity well, and have good durability. some disadvantages include hypersensitivity, adverse tissue reactions and bad aesthetics. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -Kennedy class 1 partially edentulous subjects indicated for framework partial denture
Key exclusion criteria (2 listed)
- Uncooperative patients
- Bad oral hygiene patients
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 |
|---|---|---|
| PEEK framework partial denturesPolymer-based framework recently introduced made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base. | Device | PEEK framework partial dentures |
| Cobalt- chromium framework partial denturesIt's a bio-compatible metal used in thin sections so less bulky, provide high strength and stiffness ,conduct heat and cold for a more natural experience, enable designs that minimize the covering of the gingival margins, allow for a stable denture base, and resistance to corrosion.Drawbacks of metal frameworks can include hypersensitivity, aesthetics because of metal metal display, oral galvanism, adverse tissue reactions, osteolysis of abutment teeth, and biofilm production | Device | Cobalt-chromium framework partial dentures |
Primary outcome
Biting force
Time frame: Change in baseline biting force from time of insertion, insertion after 1 month and after 3 months
Biting force of the patient wearing the removable partial denture measured by I-load sensor device.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Results publicationAl-Jammali ZM. Clinical Evaluation of Maximum Bite Force in Patient with Heat Cure acrylic and Flexible Partial Dentures. Medical Journal of Babylon. 2017;14(3):509-17.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEK framework partial dentures and Cobalt- chromium framework partial dentures in people with Mandibular Prosthesis User, 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 2 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 17 Dec 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 Amr Ha Mohammed, Master (+201001600625, amr_hatim@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biting force (time frame: Change in baseline biting force from time of insertion, insertion after 1 month and after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03777423, which also lists 1 linked publication.
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 17 Dec 2018.