Bone LossNCT06164990
(PEKK) Framework for Mandibular Implant-supported Complete Fixed Prostheses
A study testing PEKK framework in people with Bone Loss and Peri-Implantitis, run by Fatma mahanna at 1 site in Egypt.
Trial summary
This clinical study aims to evaluate the effect of using PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept on peri-implant tissues health Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Peri-Implantitis
- What is being tested?
- PEKK framework
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2022to 10 Nov 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Maxillary and mandibular alveolar ridges were covered with healthy, firm, relatively even thickness and even compressible mucosa and free from any signs of inflammation or flabbiness.
- Patients had completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height not less than 15 mm in the interforaminal area and at least 12mm posteriorly
- All patients had sufficient inter-arch space
- All patients complained of insufficient retention and stability of their conventional mandibular dentures.
- All patients were of Angel's class I maxillo-mandibular relationship.
Who cannot join
- Patients with absolute contraindications for implant placement, such as active cancer and diseases of the immune system.
- Patients with metabolic diseases that are directly related to bone resorption, such as uncontrolled diabetes, osteoporosis, and hyperparathyroidism.
- Patients with general contraindications for surgical procedures, such as hematologic diseases, hepatic patients, patients with bleeding disorders, and serious problems with coagulation.
- Patients with a history of irradiation of the head and neck region or chemotherapy in the last 3 years were also excluded.
- Patients with relative contraindications such as a history of parafunctional habits (such as bruxism and clenching), smoking, alcoholism, and patients with any physical reasons that could affect follow-up.
- Patients with local contraindications for implant placement, such as localized bone defects.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry, mansoura university
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Polyether Ketone Ketone (PEKK) Framework for Mandibular Implant-supported Complete Fixed Dental Prostheses With All-on-four Treatment Concept Clinical and Radiographic Study
This clinical study aims to evaluate the effect of using PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept on peri-implant tissues health
Read the detailed description
The aim of this clinical study is to evaluate the effect of using PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept on peri-implant tissues health regarding the following parameters:
- Modified Plaque index
- Modified Gingival index
- Peri-implant probing pocket depth
Radiographic evaluation (periapical x-ray):
Marginal bone height changes
- Conditions
- Bone Loss, Peri-Implantitis
- Being tested
- PEKK framework
- Medical subject headings
- Bone Diseases, Metabolic, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEKK frameworkOther
PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept
| Study group | Role | What they receive |
|---|---|---|
| PEKK (Pekkton) framework | Experimental | PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept and evaluated regarding peri-implant tissue health Receives: Other: PEKK framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-implant tissues health (Clinical)
Modified gingival index
Measured: 1 year
modified plaque index
peri-implant tissues health (Clinical)
Measured: 1 year
peri-implant probing depth
Probing depth using plastic periodontal probe
Measured: 1 year
Peri-implant radiographic evaluation
Marginal bone height changes using periapical radiograph
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start10 May 2022
- Primary completion15 Jun 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatma mahanna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatma mahanna, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164990
- Sponsor's protocol ID
- A01100522
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 11 Dec 2023
- Results posted
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyether Ketone Ketone (PEKK) Framework for Mandibular Implant-supported Complete Fixed Dental Prostheses With All-on-four Treatment Concept Clinical and Radiographic Study
- ClinicalTrials.gov ID
- NCT06164990
- Acronym / sponsor ID
- A01100522
- Conditions
- Bone Loss, Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fatma mahannaUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 11 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.
This clinical study aims to evaluate the effect of using PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept on peri-implant tissues health
Detailed description
The aim of this clinical study is to evaluate the effect of using PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept on peri-implant tissues health regarding the following parameters:
- Modified Plaque index
- Modified Gingival index
- Peri-implant probing pocket depth
Radiographic evaluation (periapical x-ray):
Marginal bone height changes
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEKK (Pekkton) framework | Experimental | Other: PEKK frameworkPEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept and evaluated regarding peri-implant tissue health |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Maxillary and mandibular alveolar ridges were covered with healthy, firm, relatively even thickness and even compressible mucosa and free from any signs of inflammation or flabbiness.
- Patients had completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height not less than 15 mm in the interforaminal area and at least 12mm posteriorly
- All patients had sufficient inter-arch space
- All patients complained of insufficient retention and stability of their conventional mandibular dentures.
- All patients were of Angel's class I maxillo-mandibular relationship.
Key exclusion criteria (6 listed)
- Patients with absolute contraindications for implant placement, such as active cancer and diseases of the immune system.
- Patients with metabolic diseases that are directly related to bone resorption, such as uncontrolled diabetes, osteoporosis, and hyperparathyroidism.
- Patients with general contraindications for surgical procedures, such as hematologic diseases, hepatic patients, patients with bleeding disorders, and serious problems with coagulation.
- Patients with a history of irradiation of the head and neck region or chemotherapy in the last 3 years were also excluded.
- Patients with relative contraindications such as a history of parafunctional habits (such as bruxism and clenching), smoking, alcoholism, and patients with any physical reasons that could affect follow-up.
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 |
|---|---|---|
| PEKK frameworkPEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept | Other | PEKK (Pekkton) framework |
Primary outcome
peri-implant tissues health (Clinical)
Time frame: 1 year
Modified gingival index
modified plaque index
Time frame: 1 year
peri-implant tissues health (Clinical)
peri-implant probing depth
Time frame: 1 year
Probing depth using plastic periodontal probe
Peri-implant radiographic evaluation
Time frame: 1 year
Marginal bone height changes using periapical radiograph
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 11 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Bone Loss
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEKK framework in people with Bone Loss and Peri-Implantitis, run by Fatma mahanna 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 6 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 11 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?
peri-implant tissues health (Clinical) (time frame: 1 year). The study lists 4 primary outcomes in all. 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 2023.