Problem With DenturesNCT02950662
(PEEK) Housing Verses Metallic Housing of Ball and Socket Attachment on Retention of Mandibular Overdenture
A study testing Overdenture in people with Problem With Dentures, run by Cairo University.
Trial summary
The aim of this study is to compare the clinical effect of PEEK housing vs. metal housing in terms of retention and patient satisfaction Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Problem With Dentures
- What is being tested?
- Overdenture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Dec 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient should be free from any systemic disease that may interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension, blood diseases, bone diseases, smoking.etc.
- Patients have completely edentulous upper and lower arches.
- Patients have healthy mucosa free from any ulceration, inflammation or infections.
- All patients are free from neuromuscular and temporomandibular joint disorders.
- Selected patients have normal maxillo-mandibular relationship (Angle class I ridge classification) with adequate inter-arch space and normal tongue size.
Who cannot join
- Patients with limited manual dexterity.
- Patients with Xerostomia, excessive salivation or pathological mucosal changes (e.g. Lichen planus, Leukoplakia…etc.)
- Pregnant females.
- Un co-operative patients.
About this study
Official title: Effect of Polyether Ether Ketone (PEEK) Housing Verses Metallic Housing of Ball and Socket Attachment on Retention of Mandibular Implant Retained Overdentures: Randomized Clinical Trial
The aim of this study is to compare the clinical effect of PEEK housing vs. metal housing in terms of retention and patient satisfaction
- Conditions
- Problem With Dentures
- Being tested
- Overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OverdentureOther
Also called Implant supported overdenture
Active comparator will be metal housing and peek housing
| Study group | Role | What they receive |
|---|---|---|
| Metal housing | Active comparator | metal housing of ball and socket attachment the intervention will be overdenture Receives: Other: Overdenture |
| Peek housing | Active comparator | Peek housing of ball and socket attachment the intervention will be overdenture Receives: Other: Overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of implant supported overdenture by using digital force meter device
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem With DenturesStudies 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
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ibrahim Eldesoky Mohamed Elbakry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950662
- Sponsor's protocol ID
- cebd-cu-2016-10-230
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Polyether Ether Ketone (PEEK) Housing Verses Metallic Housing of Ball and Socket Attachment on Retention of Mandibular Implant Retained Overdentures: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02950662
- Acronym / sponsor ID
- cebd-cu-2016-10-230
- Conditions
- Problem With Dentures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- 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.
The aim of this study is to compare the clinical effect of PEEK housing vs. metal housing in terms of retention and patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal housing | Active comparator | Other: Overdenturemetal housing of ball and socket attachment the intervention will be overdenture |
| Peek housing | Active comparator | Other: OverdenturePeek housing of ball and socket attachment the intervention will be overdenture |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient should be free from any systemic disease that may interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension, blood diseases, bone diseases, smoking.etc.
- Patients have completely edentulous upper and lower arches.
- Patients have healthy mucosa free from any ulceration, inflammation or infections.
- All patients are free from neuromuscular and temporomandibular joint disorders.
- Selected patients have normal maxillo-mandibular relationship (Angle class I ridge classification) with adequate inter-arch space and normal tongue size.
Key exclusion criteria (4 listed)
- Patients with limited manual dexterity.
- Patients with Xerostomia, excessive salivation or pathological mucosal changes (e.g. Lichen planus, Leukoplakia…etc.)
- Pregnant females.
- Un co-operative 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 |
|---|---|---|
| OverdentureAlso: Implant supported overdentureActive comparator will be metal housing and peek housing | Other | Metal housing, Peek housing |
Primary outcome
Retention of implant supported overdenture by using digital force meter device
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- 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.
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 Overdenture in people with Problem With Dentures, 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 5 inclusion and 4 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 1 Nov 2016. 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?
Retention of implant supported overdenture by using digital force meter device (time frame: 3 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 1 Nov 2016.