Alveolar Bone LossNCT06176014
Effect of Using (PEKK) Framework Versus (Co- Cr) Framework on The Bone of Mandibular Implant Supported Hybrid Prostheses
A study testing implant placement in people with Alveolar Bone Loss, run by Ain Shams University at 1 site in Egypt.
Trial summary
the purposse of the study To evaluate the effect of implant supported hybrid prostheses on the bone of the supporting structure of edentulous mandible using Polyetherketoneketone (PEKK) framework versus cobalt chromium framework. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jun 2021to 2 Sep 2023
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient's age range from 50 to 60 year's old.
- All patients are with completely edentulous mandible.
- Good oral hygiene is mandatory.
- Sufficient interarch space to accept implant supported fixed prosthesis will be diagnosed by mounted diagnostic casts.
- Firm and healthy mucosa covering the alveolar ridge.
- Minimum bone width 5.5mm buccolinguallly and 10 mm height will be diagnosed by the preoperative cone beam CT scan.
Who cannot join
- - Vulnerable group; prisoners, mentally, physically disabled, pregnant females.
- Patients with Para functional habits.
- Patients having TMJ disorders.
- Uncontrolled diabetic patients
- Patients have any medical condition or any disease that could interfere with implant placement or affect bone loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Using Polyetherketoneketone (PEKK) Framework Versus Cobalt Chromium Framework on The Supporting Structures of Mandibular Implant Supported Hybrid Prostheses
the purposse of the study To evaluate the effect of implant supported hybrid prostheses on the bone of the supporting structure of edentulous mandible using Polyetherketoneketone (PEKK) framework versus cobalt chromium framework. fourteen female patients with lower single edentulous ridges are chosen with adequate dental hygiene, enough interarch space and free of systemic diseases and parafunctional habits. Patients who received new single dentures are randomly allocated into each group using computer software program and five intraforaminal implants were inserted parallel using surgical guide.
Read the detailed description
Patient's approval:
- All patients will be informed in details about the nature of the investigation and the aim of the study. They will agree to take part in the study and will sign on an informed consent form.
- All participants will be given notice about their privacy practices, their legal duties and their rights.
- In case of implant treatment failure, the patients will receive a new well-fitting denture.
Patient's grouping:
In this study there will be two equal groups, grouping will be based on the material that will be used for framework construction:
Group I: framework will be fabricated using PEKK. Group II: frame work will be fabricated using cobalt chromium alloy.
Clinical steps:
Pre-prosthetic phase:-
- Conventional single lower denture will be made for all patients.
- Occlusal adjustment of upper teeth will be done for all patients.
- The single lower denture will be duplicated with radiographic markers and CBCT will be used to determine exact position of implants.
Surgical phase:-
- Five conventional implants in intraforaminal area will be placed according to the planned cone beam CT using surgical guide to accurately place the implants.
- Postoperative analgesics and anti-inflammatory medications will be described.
- After osseointegration, second surgery will be carried out and healing abutment will be screwed for each implant.
Prosthetic phase:-
- After healing period open top tray impression will be made.
- Jaw relation record will be taken using record bases and wax rims.
- Group I: The PEKK framework will be milled using milling machine.
- Group II: cobalt chromium framework will be made with wax pattern milling then casted by conventional method.
- The PEKK framework will be veneered with zirconia and the cobalt chromium will be veneered with porcelain.
- Implant supported fixed detachable prostheses using PEKK framework or cobalt-chromium framework will be screw retained to conventional implants.
- Conditions
- Alveolar Bone Loss
- Being tested
- implant placement
- Keywords
- hybrid prosthesis, PEKK framework, PFM framework
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placementProcedure or surgery
Also called final prostheses was made on 5 implants
5 implant were placed in intraforaminal area using surgical guide
| Study group | Role | What they receive |
|---|---|---|
| (PEKK fixed hybrid prostheses | Other | 5 implants were placed in mandibular arch by surgical guide and after 3 months the prostheses was constructed by using digital workflow Receives: Procedure: implant placement |
| PFM fixed hybrid prostheses | Other | 5 implants were placed in mandibular arch by surgical guide and after 3 months the prostheses was constructed by using digital workflow until making wax pattern the casting was made. Receives: Procedure: implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of bone loss around implant
The points of first bone contact with the fixture platform were detected and changes of those points position through the two years of observation were registered as a criterion of bone changes with further calculation of average values. A software ruler of CBCT was used to measure the crestal bone height in contact with the implant from the four aspects (buccal, lingual, mesial and distal).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start8 Jun 2021
- Primary completion2 Sep 2022
- Study completion2 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- to compare PEKK framework for hybrid prostheses ( fixed detachable ) versus PFM framework
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- dina essam bahig, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176014
- Sponsor's protocol ID
- FDASU-RecID032134
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Polyetherketoneketone (PEKK) Framework Versus Cobalt Chromium Framework on The Supporting Structures of Mandibular Implant Supported Hybrid Prostheses
- ClinicalTrials.gov ID
- NCT06176014
- Acronym / sponsor ID
- FDASU-RecID032134
- Conditions
- Alveolar Bone Loss
- Keywords
- hybrid prosthesis, PEKK framework, PFM framework
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 19 Dec 2023 (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 purposse of the study To evaluate the effect of implant supported hybrid prostheses on the bone of the supporting structure of edentulous mandible using Polyetherketoneketone (PEKK) framework versus cobalt chromium framework. fourteen female patients with lower single edentulous ridges are chosen with adequate dental hygiene, enough interarch space and free of systemic diseases and parafunctional habits. Patients who received new single dentures are randomly allocated into each group using computer software program and five intraforaminal implants were inserted parallel using surgical guide.
Detailed description
Patient's approval:
- All patients will be informed in details about the nature of the investigation and the aim of the study. They will agree to take part in the study and will sign on an informed consent form.
- All participants will be given notice about their privacy practices, their legal duties and their rights.
- In case of implant treatment failure, the patients will receive a new well-fitting denture.
Patient's grouping:
In this study there will be two equal groups, grouping will be based on the material that will be used for framework construction:
Group I: framework will be fabricated using PEKK. Group II: frame work will be fabricated using cobalt chromium alloy.
Clinical steps:
Pre-prosthetic phase:-
- Conventional single lower denture will be made for all patients.
- Occlusal adjustment of upper teeth will be done for all patients.
- The single lower denture will be duplicated with radiographic markers and CBCT will be used to determine exact position of implants.
Surgical phase:-
- Five conventional implants in intraforaminal area will be placed according to the planned cone beam CT using surgical guide to accurately place the implants.
- Postoperative analgesics and anti-inflammatory medications will be described.
- After osseointegration, second surgery will be carried out and healing abutment will be screwed for each implant.
Prosthetic phase:-
- After healing period open top tray impression will be made.
- Jaw relation record will be taken using record bases and wax rims.
- Group I: The PEKK framework will be milled using milling machine.
- Group II: cobalt chromium framework will be made with wax pattern milling then casted by conventional method.
- The PEKK framework will be veneered with zirconia and the cobalt chromium will be veneered with porcelain.
- Implant supported fixed detachable prostheses using PEKK framework or cobalt-chromium framework will be screw retained to conventional implants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- to compare PEKK framework for hybrid prostheses ( fixed detachable ) versus PFM framework
| Arm | Type | Receives |
|---|---|---|
| (PEKK fixed hybrid prostheses | Other | Procedure: implant placement5 implants were placed in mandibular arch by surgical guide and after 3 months the prostheses was constructed by using digital workflow |
| PFM fixed hybrid prostheses | Other | Procedure: implant placement5 implants were placed in mandibular arch by surgical guide and after 3 months the prostheses was constructed by using digital workflow until making wax pattern the casting was made. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient's age range from 50 to 60 year's old.
- All patients are with completely edentulous mandible.
- Good oral hygiene is mandatory.
- Sufficient interarch space to accept implant supported fixed prosthesis will be diagnosed by mounted diagnostic casts.
- Firm and healthy mucosa covering the alveolar ridge.
Key exclusion criteria (5 listed)
- - Vulnerable group; prisoners, mentally, physically disabled, pregnant females.
- Patients with Para functional habits.
- Patients having TMJ disorders.
- Uncontrolled diabetic patients
- Patients have any medical condition or any disease that could interfere with implant placement or affect bone loss.
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 |
|---|---|---|
| implant placementAlso: final prostheses was made on 5 implants5 implant were placed in intraforaminal area using surgical guide | Procedure or surgery | (PEKK fixed hybrid prostheses, PFM fixed hybrid prostheses |
Primary outcome
amount of bone loss around implant
Time frame: 2 years
The points of first bone contact with the fixture platform were detected and changes of those points position through the two years of observation were registered as a criterion of bone changes with further calculation of average values. A software ruler of CBCT was used to measure the crestal bone height in contact with the implant from the four aspects (buccal, lingual, mesial and distal).
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 19 Dec 2023.
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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.
dina essam bahig principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant placement in people with Alveolar Bone Loss, 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 6 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 19 Dec 2023. 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?
amount of bone loss around implant (time frame: 2 years). 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 Dec 2023.