Completely EdentulousNCT06219811
Prosthetic Maintenance of Two Implant-Retained Overdentures Reinforced With PEKK Versus Co-Cr Frameworks
A study testing Two implant -retained overdenture reinforced with Co-Cr framework and Two implant -retained overdenture reinforced with PEEK framework in people with Completely Edentulous, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial is to compare and assess the prosthetic maintenance of two implant-retained mandibular overdentures reinforced with PEKK and Co-Cr frameworks after twelve months. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Completely Edentulous
- What is being tested?
- Two implant -retained overdenture reinforced with Co-Cr framework and Two implant -retained overdenture reinforced with PEEK framework
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Jan 2024
- 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 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range between 50-70 years old.
- Completely edentulous patients
- Systemically free from any disease that contraindicates implant placement.
- A minimum of 12 -15 millimeters of bone height and 6 mm bone width at canine areas diagnosed from the pre-operative cone beam CT.
- Sufficient inter-arch space (15mm) to accommodate the mandibular implant-retained overdentures.
Who cannot join
- Patients with bone or mucosal diseases.
- Heavy smokers.
- Patients with uncontrolled metabolic disorders such as diabetes mellitus.
- Patients with parafunctional habits.
- Patients with conditions that might complicate the treatment, such as: severe gag reflex, limited mouth opening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prosthetic Maintenance Assessment for Two Implant-Retained Overdentures Reinforced With PEKK Versus Co-Cr Framework: A Randomized Controlled Clinical Trial
The goal of this randomized clinical trial is to compare and assess the prosthetic maintenance of two implant-retained mandibular overdentures reinforced with PEKK and Co-Cr frameworks after twelve months. Twenty-four participants were randomly assigned to two groups: Group I received a mandibular implant-retained overdenture reinforced with a Co-Cr framework, while Group II received a mandibular implant-retained overdenture reinforced with a PEKK framework. Also, both groups were rehabilitated with a maxillary complete removable denture.
Read the detailed description
Twenty-four participants with edentulous maxillary and mandibular ridges underwent meticulous selection, with two implants placed in the mandibular canine areas through a two-stage surgical technique facilitated by a radiographic and surgical stent. Following this, patients were provided with maxillary and mandibular complete removable dentures relined with soft liners. After the subsequent three-month osseointegration period, ball attachments were introduced. Patients were randomly allocated to two groups based on the type of prosthesis they received. Group I received mandibular implant-retained overdenture reinforced with the Co-Cr framework, while Group II received mandibular implant-retained overdenture reinforced with the PEKK framework, both groups received complete removable dentures for the maxillary arch. The assessment of prosthetic maintenance for mandibular implant-retained overdentures in both groups was conducted twelve months post-denture insertion.
- Conditions
- Completely Edentulous
- Being tested
- Two implant -retained overdenture reinforced with Co-Cr framework, Two implant -retained overdenture reinforced with PEEK framework
- Keywords
- Dental implants, Maintenance/standards, Overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two implant -retained overdenture reinforced with Co-Cr frameworkDevice
Also called implant retained overdenture
The intervention is made from polymethylmethacrylate reinforced with cobalt chromium ( Co-Cr) framework.
Two implant -retained overdenture reinforced with PEEK frameworkDevice
Also called implant retained overdenture
The intervention is made from polymethylmethacrylate reinforced with Polyetherketoneketone ( PEEK) framework.
| Study group | Role | What they receive |
|---|---|---|
| Mandibular implant-retained overdenture reinforced with a Co-Cr framework | Experimental | The patient received a mandibular implant-retained acrylic overdenture reinforced with a Co-Cr framework. The framework is manufactured by milling polymethylmethacrylate (PMMA) and then the PMMA undergo conventional casting to produce cobalt chromium (Co-Cr) framework. The framework included in the overdenture by conventional processing technique. Receives: Device: Two implant -retained overdenture reinforced with Co-Cr framework |
| Mandibular implant-retained overdenture reinforced with a PEKK framework | Active comparator | The patient received a mandibular implant-retained acrylic overdenture reinforced with a Polyetherketoneketone (PEKK) framework. The framework is manufactured by milling PEKK the framework included in the overdenture by conventional processing technique. Receives: Device: Two implant -retained overdenture reinforced with PEEK framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Prosthetic Maintenance of both types of implant retained overdentures
Evaluation of prosthetic maintenance for mandibular implant-retained overdentures in both groups was made after twelve months of overdenture insertion. Prosthetic maintenance is a checklist for the following aspects that were inspected regarding screw (screw loosening, screw fracture), attachments (wear, distortion, fracture, replacement), and overdentures (reline, remake, fracture, teeth wear, teeth separation, or fracture).maintenance for complication assed through counting frequency of incidence. The unit of measurement used is percentage.
Measured: twelve months after delivery of implant retained overdenture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Aug 2022
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Completely EdentulousStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia M Refai, Ain Shams University
- Investigators
- Omnia MS Refai, PHD, Principal investigator, Faculty of Dentistry ,Ain Shams UniversityHeba A Salama, PHD, Principal investigator, Faculty of Dentistry , Misr International Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219811
- Sponsor's protocol ID
- FDASU-Rec PC 122352
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Maintenance Assessment for Two Implant-Retained Overdentures Reinforced With PEKK Versus Co-Cr Framework: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06219811
- Acronym / sponsor ID
- FDASU-Rec PC 122352
- Conditions
- Completely Edentulous
- Keywords
- Dental implants, Maintenance/standards, Overdenture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 23 Jan 2024 (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.
The goal of this randomized clinical trial is to compare and assess the prosthetic maintenance of two implant-retained mandibular overdentures reinforced with PEKK and Co-Cr frameworks after twelve months. Twenty-four participants were randomly assigned to two groups: Group I received a mandibular implant-retained overdenture reinforced with a Co-Cr framework, while Group II received a mandibular implant-retained overdenture reinforced with a PEKK framework. Also, both groups were rehabilitated with a maxillary complete removable denture.
Detailed description
Twenty-four participants with edentulous maxillary and mandibular ridges underwent meticulous selection, with two implants placed in the mandibular canine areas through a two-stage surgical technique facilitated by a radiographic and surgical stent. Following this, patients were provided with maxillary and mandibular complete removable dentures relined with soft liners. After the subsequent three-month osseointegration period, ball attachments were introduced. Patients were randomly allocated to two groups based on the type of prosthesis they received. Group I received mandibular implant-retained overdenture reinforced with the Co-Cr framework, while Group II received mandibular implant-retained overdenture reinforced with the PEKK framework, both groups received complete removable dentures for the maxillary arch. The assessment of prosthetic maintenance for mandibular implant-retained overdentures in both groups was conducted twelve months post-denture insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandibular implant-retained overdenture reinforced with a Co-Cr framework | Experimental | Device: Two implant -retained overdenture reinforced with Co-Cr frameworkThe patient received a mandibular implant-retained acrylic overdenture reinforced with a Co-Cr framework. The framework is manufactured by milling polymethylmethacrylate (PMMA) and then the PMMA undergo conventional casting to produce cobalt chromium (Co-Cr) framework. The framework included in the overdenture by conventional processing technique. |
| Mandibular implant-retained overdenture reinforced with a PEKK framework | Active comparator | Device: Two implant -retained overdenture reinforced with PEEK frameworkThe patient received a mandibular implant-retained acrylic overdenture reinforced with a Polyetherketoneketone (PEKK) framework. The framework is manufactured by milling PEKK the framework included in the overdenture by conventional processing technique. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range between 50-70 years old.
- Completely edentulous patients
- Systemically free from any disease that contraindicates implant placement.
- A minimum of 12 -15 millimeters of bone height and 6 mm bone width at canine areas diagnosed from the pre-operative cone beam CT.
- Sufficient inter-arch space (15mm) to accommodate the mandibular implant-retained overdentures.
Key exclusion criteria (5 listed)
- Patients with bone or mucosal diseases.
- Heavy smokers.
- Patients with uncontrolled metabolic disorders such as diabetes mellitus.
- Patients with parafunctional habits.
- Patients with conditions that might complicate the treatment, such as: severe gag reflex, limited mouth opening.
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 |
|---|---|---|
| Two implant -retained overdenture reinforced with Co-Cr frameworkAlso: implant retained overdentureThe intervention is made from polymethylmethacrylate reinforced with cobalt chromium ( Co-Cr) framework. | Device | Mandibular implant-retained overdenture reinforced with a Co-Cr framework |
| Two implant -retained overdenture reinforced with PEEK frameworkAlso: implant retained overdentureThe intervention is made from polymethylmethacrylate reinforced with Polyetherketoneketone ( PEEK) framework. | Device | Mandibular implant-retained overdenture reinforced with a PEKK framework |
Primary outcome
Evaluation of Prosthetic Maintenance of both types of implant retained overdentures
Time frame: twelve months after delivery of implant retained overdenture
Evaluation of prosthetic maintenance for mandibular implant-retained overdentures in both groups was made after twelve months of overdenture insertion. Prosthetic maintenance is a checklist for the following aspects that were inspected regarding screw (screw loosening, screw fracture), attachments (wear, distortion, fracture, replacement), and overdentures (reline, remake, fracture, teeth wear, teeth separation, or fracture).maintenance for complication assed through counting frequency of incidence. The unit of measurement used is percentage.
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 23 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Omnia MS Refai, PHD principal investigator
Faculty of Dentistry ,Ain Shams University
Heba A Salama, PHD principal investigator
Faculty of Dentistry , Misr International Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two implant -retained overdenture reinforced with Co-Cr framework and Two implant -retained overdenture reinforced with PEEK framework in people with Completely Edentulous, run by Ain Shams 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 5 inclusion and 5 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 23 Jan 2024. 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?
Evaluation of Prosthetic Maintenance of both types of implant retained overdentures (time frame: twelve months after delivery of implant retained overdenture). 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 23 Jan 2024.