Partially Edentulous MandibleNCT03771248
Polyetheretherketone vs Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Patients Regarding Oral Health Related Quality of Life
A study testing peek telescopic partial denture in people with Partially Edentulous Mandible, run by Cairo University.
Trial summary
Dentistry is a rapidly progressing field with innumerable advances taking place on a day to day basis. The application of newer technologies and materials has advanced the specialty of prosthodontics and the services rendered to the patients. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Partially Edentulous Mandible
- What is being tested?
- peek telescopic partial denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Jul 2020
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - Kennedy Class I Partially edentulous patients.
- Patients with good oral hygiene.
- The distal abutment bilaterally should be a premolar.
- Abutment teeth should be in a good periodontal condition.
- Sufficient inter-arch space, any super-eruptions should be treated before beginning of treatment.
- There should be no modifications spaces in the arch to be treated, and if found it should be treated with a fixed partial denture first.
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- Normal tongue size
- Medically free from any disease that might affect bone support
- Patients with no history of bad oral habits as (Bruxism or Clenching) and free from any T.M.J disorders.
Who cannot join
- Patients with bad oral hygiene.
- Teeth with severe malalignment.
- The arch to be treated is opposed by a completely edentulous arch.
- Unmotivated patient.
- Patient with a medical disease that will hinder his ability to be committed to the treatment.
- Patients on a radiation therapy.
- Patients with xerostomia.
- Patients with a history of drug, alcohol abuse or psychiatric disorder.
About this study
Official title: A Comparison Between Polyetheretherketone and Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Partially Edentulous Patients Regarding Oral Health Related Quality of Life (A Randomized Clinical Trial)
Dentistry is a rapidly progressing field with innumerable advances taking place on a day to day basis. The application of newer technologies and materials has advanced the specialty of prosthodontics and the services rendered to the patients.
Taking into consideration that PEEK as a material wasn't clinically investigated to be used as a material for routine use, however PEEK in removable partial dentures will help in making many steps easier and reach patients demands regarding esthetics. Also, owing to the superior mechanical and biological properties of PEEK, it will not be surprising if dentures constructed from the polymer are routinely constructed in near future.
Read the detailed description
On fabrication of telescopic removable partial denture, choosing the material is a major step in the success of the treatment. There are different aspects that should be taken into consideration while choosing it. Beginning with retention as it is a crucial aspect. The retention of the telescopic partial denture is gained from the friction between the primary and secondary crowns. The chosen material should be able to maintain this type of retention for the longest possible period.
The esthetics also affects the treatment choice and patients preference, patients would choose metal free restorations over the ones that display metal. Finally the load distribution between the residual ridge and abutment should be equalized and transmitted in a favorable way. Otherwise one of the following consequences will occur; either overload on the abutment teeth followed by bone loss and abutment mobility or this overload is on the residual ridge leading to fast, progressive bone loss.
Cobalt chromium that is used for fabricating the telescopic removable partial denture is considered that most suitable material up till this moment. However, it doesn't fulfill much of the previous points.
As there will always be a continued improvement of materials and techniques used in dentistry especially in prosthodontics, innovative techniques must be regarded as potential alternatives to traditional materials.
PEEK is from the innovative materials that has shown promising results in different branches. However, to date no clinical studies or systematic reviews focusing on the use of PEEK dentures have been published, therefore more investigations are needed in this field.
- Conditions
- Partially Edentulous Mandible
- Being tested
- peek telescopic partial denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peek telescopic partial dentureDevice
removable partial denture
| Study group | Role | What they receive |
|---|---|---|
| Co-cr telescopic partial denture | Active comparator | A removable partial denture, that gains retention from a telescopic crown made of cobalt chromium Receives: Device: peek telescopic partial denture |
| PEEK telescopic partial denture | Experimental | A removable partial denture, its attachment is a telescopic crown made of PEEK Receives: Device: peek telescopic partial denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral health impact profile
questionnaire
Measured: 12 months
Secondary outcomes (2)
probing depth of abutment teeth
using williams graduated probe
Measured: 12 months
abutment mobility
millers classification
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partially Edentulous MandibleStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tasneem gamal youssef el mashad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771248
- Sponsor's protocol ID
- Prosthesis1234
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Polyetheretherketone and Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Partially Edentulous Patients Regarding Oral Health Related Quality of Life (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03771248
- Acronym / sponsor ID
- Prosthesis1234
- Conditions
- Partially Edentulous Mandible
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 11 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.
Dentistry is a rapidly progressing field with innumerable advances taking place on a day to day basis. The application of newer technologies and materials has advanced the specialty of prosthodontics and the services rendered to the patients.
Taking into consideration that PEEK as a material wasn't clinically investigated to be used as a material for routine use, however PEEK in removable partial dentures will help in making many steps easier and reach patients demands regarding esthetics. Also, owing to the superior mechanical and biological properties of PEEK, it will not be surprising if dentures constructed from the polymer are routinely constructed in near future.
Detailed description
On fabrication of telescopic removable partial denture, choosing the material is a major step in the success of the treatment. There are different aspects that should be taken into consideration while choosing it. Beginning with retention as it is a crucial aspect. The retention of the telescopic partial denture is gained from the friction between the primary and secondary crowns. The chosen material should be able to maintain this type of retention for the longest possible period.
The esthetics also affects the treatment choice and patients preference, patients would choose metal free restorations over the ones that display metal. Finally the load distribution between the residual ridge and abutment should be equalized and transmitted in a favorable way. Otherwise one of the following consequences will occur; either overload on the abutment teeth followed by bone loss and abutment mobility or this overload is on the residual ridge leading to fast, progressive bone loss.
Cobalt chromium that is used for fabricating the telescopic removable partial denture is considered that most suitable material up till this moment. However, it doesn't fulfill much of the previous points.
As there will always be a continued improvement of materials and techniques used in dentistry especially in prosthodontics, innovative techniques must be regarded as potential alternatives to traditional materials.
PEEK is from the innovative materials that has shown promising results in different branches. However, to date no clinical studies or systematic reviews focusing on the use of PEEK dentures have been published, therefore more investigations are needed in this field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-cr telescopic partial denture | Active comparator | Device: peek telescopic partial dentureA removable partial denture, that gains retention from a telescopic crown made of cobalt chromium |
| PEEK telescopic partial denture | Experimental | Device: peek telescopic partial dentureA removable partial denture, its attachment is a telescopic crown made of PEEK |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- - Kennedy Class I Partially edentulous patients.
- Patients with good oral hygiene.
- The distal abutment bilaterally should be a premolar.
- Abutment teeth should be in a good periodontal condition.
- Sufficient inter-arch space, any super-eruptions should be treated before beginning of treatment.
Key exclusion criteria (8 listed)
- Patients with bad oral hygiene.
- Teeth with severe malalignment.
- The arch to be treated is opposed by a completely edentulous arch.
- Unmotivated patient.
- Patient with a medical disease that will hinder his ability to be committed to the treatment.
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 telescopic partial dentureremovable partial denture | Device | Co-cr telescopic partial denture, PEEK telescopic partial denture |
Primary outcome
oral health impact profile
Time frame: 12 months
questionnaire
2 secondary outcomes
probing depth of abutment teeth
Time frame: 12 months
abutment mobility
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing peek telescopic partial denture in people with Partially Edentulous Mandible, run by Cairo University.
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 9 inclusion and 8 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
oral health impact profile (time frame: 12 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 11 Dec 2018; AzTrials last refreshed its copy on 6 Nov 2026.