Mastication DisorderNCT05193110
Two Years Follow up of Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis
A study testing Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis in people with Mastication Disorder, run by Mansoura University at 1 site in Egypt.
Trial summary
This clinical trial demonstrates prosthetic management of patients complained from lack of satisfaction and function of maxillary conventional complete denture as a result of severe maxillary ridge resorption seeking for fixed restoration. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mastication Disorder
- What is being tested?
- Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Dec 2019to 28 Dec 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with absolute contraindications for surgical procedures such as: active cancer ,immunocompromised patients
- Patients with relative contraindications such as: patients with history of para functional habits (bruxism, clenching), bad habits as heavy smoking and alcoholism.. Also patients with history of radiation therapy in the head and neck region
- Patients with contraindication for grafting procedures.
- Non cooperative patients neither who don't attend regular appointments nor following the instructions during construction procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of CAD/CAM Versus Injection Molding Techniques of Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis
This clinical trial demonstrates prosthetic management of patients complained from lack of satisfaction and function of maxillary conventional complete denture as a result of severe maxillary ridge resorption seeking for fixed restoration. They were attended to the Department of Prosthodontics, Faculty of Dentistry, Mansoura University (Mansoura, Egypt). They demonstrated sever bone loss especially in the posterior region which complicate conventional implant placement for full arch prosthesis. Eight PEEK sub-periosteal implants were surgically placed. Probing depth was measured after three \& six months from sub-periosteal implant placement. Tumor necrosis factor-alpha (TNF-α) \& Interleukin-8(IL-8) Peri-abutment cervicular fluid were measured one month, three months , six months \& one year from sub-periosteal implant placement. Clinical \& Radiographic examination (CBCT) was done two years after sub-periosteal implant placement.
Read the detailed description
Panoramic radiograph was done for each patient for diagnostic criteria, to evaluate condition of the ridge and to be a base line for further radiographic follow up examination . Fabrication of sub-periosteal implant was done as following: Computed tomography (CT) was done for each patient while wearing the denture with radio opaque markers and saved as STL file .CBCT was done for each denture and saved as STL file. Both STL files were aligned together to obtain a complete virtual model of the patient with all information about bone, soft tissue and the new prosthesis. This STL file then was processed and printed, in resin, using powerful rapid prototyping machine. The sub-periosteal implant was designed virtually on the virtual model by using dental wings(coDiagnostiXTM programme) .Location of the 4 abutments were designed to be on the canines and first molar region. Screws location were designed to be on compact bone, anterior nasal spine, hard palate and zygomatic bone .Height of the abutments were 5-6 mm..Thickness of the PEEK was 1.5 mm during construction and after finishing and polishing become 1.2 mm The sub-periosteal implant was then saved as an STL file, this file was first printed in resin to verify the accuracy of the fit on the 3D printed model of the patient . Finishing and polishing was done by PEEK polishing sets then the framework was decontaminated and packaged for sterilization by autoclave.
The surgery was done by a surgeon under local anaesthesia 4% Articaine with 1:100,000 epinephrine for hemostasis (articaine, Insiba, Spain) to the maxillary arch.The flap was done using three incision lines. the crestal incision was performed at the crest of the ridge, Two oblique releasing incisions were done at the distal ends of the crestal incision. Elevating the flap was done by the mucoperiosteal elevator. Sub-periosteal PEEK implant was placed and checked for its correct position, after placing the sub-periosteal implant, Fixation was done by 2mm diameter Fixation screws(AntonHipp,Germany) to the peek framework and bone. Continuous irrigation was done during drilling to avoid heat generation and bone necrosis. The flap was closed while the 4 abutments projecting from the flap using 3/0 resorbable vicryl sutures .1gm Amoxicillin was prescribed twice daily for every patient.Diclofenac potassium was prescribed to relieve pain.Chlorohexidine mouth wash was prescribed to decrease inflammation and swelling. Instruction was given to both patients for soft diet for 1 weak, cold fomentations and not to move the check muscle strongly to avoid releasing of the sutures. Patients were instructed to periodic recall every 2 week for 6 weeks. The implant was left for healing then evaluation of soft probing depth around the abutments were done three months \& six months after surgical placement. For all surfaces Buccal(B), Palatal(P), Mesial(M), Distal(D). (TNF-α) \& (IL-8) Peri-abutment cervicular fluid was detected by paper points \& transferred to laboratory, specimens were evaluated by ELISA test one month ,three months , six months \& 12 months after surgical placement. Clinical \& Radiographic (CBCT) examination was done after 2 years from sub-periosteal implant placement.
After complete healing of the soft tissue, preparation was done to the PEEK abutments under copious irrigation with saline to avoid heat generation. Finishing and polishing of the PEEK abutments were done by using composite polishing instruments. Impression was taken to the maxillary arch using addition silicon impression material (Heavy and light body) in one step. Proper vertical dimension was recorded, and then Face-bow transfer record was done to orient the maxillary cast to the semi-adjustable articulator. Horizontal jaw relation was recorded; centric inter-occlusal record was made. The mandibular denture was mounted on the articulator using centric inter-occlusal wax record. PEEK framework was done for the abutments; Setting up all the artificial teeth was made on the articulator. The maxillary PEEK framework with teeth were tried in the patient's mouth then processed in to final prosthesis .Temporary cement was used after insertion of the prosthesis to enable peri-implant probing depth \& cerivicular fluid evaluation then final cementation of the fixed prosthesis was done by DTK. Strict oral hygiene measures \& electric water jet irrigator tooth brush was instructed for each patient
- Conditions
- Mastication Disorder
- Being tested
- Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis
- Keywords
- Sub-periosteal implant; PEEK; CAD/CAM prosthesis; Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed ProsthesisOther
Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis fabricated by digital \& milling technology
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM PEEK sub-periosteal implant retaining maxillary fixed prosthesis | Other | 4 PEEK sub-periosteal implants were surgically placed for patients demonstrated sever bone loss especially in the posterior region which complicate conventional implant placement for full arch prosthesis.The PEEK framework was fabricated by CAD/CAM method Receives: Other: Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis |
| Injection molding PEEK sub-periosteal implant retaining maxillary fixed prosthesis | Other | 4 CAD/CAM PEEK sub-periosteal implants were surgically placed for patients demonstrated sever bone loss especially in the posterior region which complicate conventional implant placement for full arch prosthesis.The PEEK framework was fabricated by injection molding technique method. Receives: Other: Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis.
PEEK sub-periosteal implants were surgically placed. Probing depth was measured after three \& six months from sub-periosteal implant placement. Tumor necrosis factor-alpha (TNF-α) \& Interleukin-8(IL-8) Peri-abutment cervicular fluid were measured one month, three months , six months \& one year from sub-periosteal implant placement.
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 posted14 Jan 2022
- Study start23 Dec 2019
- Primary completion2 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastication DisorderStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salah A. Hegazy, PhD, Study chair, salahhegazy2003@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193110
- Sponsor's protocol ID
- A09091019
- Status last verified
- Dec 2021
- First submitted
- 30 Dec 2021
- Last updated
- 14 Jan 2022
- 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 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of CAD/CAM Versus Injection Molding Techniques of Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis
- ClinicalTrials.gov ID
- NCT05193110
- Acronym / sponsor ID
- A09091019
- Conditions
- Mastication Disorder
- Keywords
- Sub-periosteal implant; PEEK; CAD/CAM prosthesis; Maxilla
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 14 Jan 2022 (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 trial demonstrates prosthetic management of patients complained from lack of satisfaction and function of maxillary conventional complete denture as a result of severe maxillary ridge resorption seeking for fixed restoration. They were attended to the Department of Prosthodontics, Faculty of Dentistry, Mansoura University (Mansoura, Egypt). They demonstrated sever bone loss especially in the posterior region which complicate conventional implant placement for full arch prosthesis. Eight PEEK sub-periosteal implants were surgically placed. Probing depth was measured after three \& six months from sub-periosteal implant placement. Tumor necrosis factor-alpha (TNF-α) \& Interleukin-8(IL-8) Peri-abutment cervicular fluid were measured one month, three months , six months \& one year from sub-periosteal implant placement. Clinical \& Radiographic examination (CBCT) was done two years after sub-periosteal implant placement.
Detailed description
Panoramic radiograph was done for each patient for diagnostic criteria, to evaluate condition of the ridge and to be a base line for further radiographic follow up examination . Fabrication of sub-periosteal implant was done as following: Computed tomography (CT) was done for each patient while wearing the denture with radio opaque markers and saved as STL file .CBCT was done for each denture and saved as STL file. Both STL files were aligned together to obtain a complete virtual model of the patient with all information about bone, soft tissue and the new prosthesis. This STL file then was processed and printed, in resin, using powerful rapid prototyping machine. The sub-periosteal implant was designed virtually on the virtual model by using dental wings(coDiagnostiXTM programme) .Location of the 4 abutments were designed to be on the canines and first molar region. Screws location were designed to be on compact bone, anterior nasal spine, hard palate and zygomatic bone .Height of the abutments were 5-6 mm..Thickness of the PEEK was 1.5 mm during construction and after finishing and polishing become 1.2 mm The sub-periosteal implant was then saved as an STL file, this file was first printed in resin to verify the accuracy of the fit on the 3D printed model of the patient . Finishing and polishing was done by PEEK polishing sets then the framework was decontaminated and packaged for sterilization by autoclave.
The surgery was done by a surgeon under local anaesthesia 4% Articaine with 1:100,000 epinephrine for hemostasis (articaine, Insiba, Spain) to the maxillary arch.The flap was done using three incision lines. the crestal incision was performed at the crest of the ridge, Two oblique releasing incisions were done at the distal ends of the crestal incision. Elevating the flap was done by the mucoperiosteal elevator. Sub-periosteal PEEK implant was placed and checked for its correct position, after placing the sub-periosteal implant, Fixation was done by 2mm diameter Fixation screws(AntonHipp,Germany) to the peek framework and bone. Continuous irrigation was done during drilling to avoid heat generation and bone necrosis. The flap was closed while the 4 abutments projecting from the flap using 3/0 resorbable vicryl sutures .1gm Amoxicillin was prescribed twice daily for every patient.Diclofenac potassium was prescribed to relieve pain.Chlorohexidine mouth wash was prescribed to decrease inflammation and swelling. Instruction was given to both patients for soft diet for 1 weak, cold fomentations and not to move the check muscle strongly to avoid releasing of the sutures. Patients were instructed to periodic recall every 2 week for 6 weeks. The implant was left for healing then evaluation of soft probing depth around the abutments were done three months \& six months after surgical placement. For all surfaces Buccal(B), Palatal(P), Mesial(M), Distal(D). (TNF-α) \& (IL-8) Peri-abutment cervicular fluid was detected by paper points \& transferred to laboratory, specimens were evaluated by ELISA test one month ,three months , six months \& 12 months after surgical placement. Clinical \& Radiographic (CBCT) examination was done after 2 years from sub-periosteal implant placement.
After complete healing of the soft tissue, preparation was done to the PEEK abutments under copious irrigation with saline to avoid heat generation. Finishing and polishing of the PEEK abutments were done by using composite polishing instruments. Impression was taken to the maxillary arch using addition silicon impression material (Heavy and light body) in one step. Proper vertical dimension was recorded, and then Face-bow transfer record was done to orient the maxillary cast to the semi-adjustable articulator. Horizontal jaw relation was recorded; centric inter-occlusal record was made. The mandibular denture was mounted on the articulator using centric inter-occlusal wax record. PEEK framework was done for the abutments; Setting up all the artificial teeth was made on the articulator. The maxillary PEEK framework with teeth were tried in the patient's mouth then processed in to final prosthesis .Temporary cement was used after insertion of the prosthesis to enable peri-implant probing depth \& cerivicular fluid evaluation then final cementation of the fixed prosthesis was done by DTK. Strict oral hygiene measures \& electric water jet irrigator tooth brush was instructed for each patient
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM PEEK sub-periosteal implant retaining maxillary fixed prosthesis | Other | Other: Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis4 PEEK sub-periosteal implants were surgically placed for patients demonstrated sever bone loss especially in the posterior region which complicate conventional implant placement for full arch prosthesis.The PEEK framework was fabricated by CAD/CAM method |
| Injection molding PEEK sub-periosteal implant retaining maxillary fixed prosthesis | Other | Other: Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis4 CAD/CAM PEEK sub-periosteal implants were surgically placed for patients demonstrated sever bone loss especially in the posterior region which complicate conventional implant placement for full arch prosthesis.The PEEK framework was fabricated by injection molding technique method. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patients with absolute contraindications for surgical procedures such as: active cancer ,immunocompromised patients
- Patients with relative contraindications such as: patients with history of para functional habits (bruxism, clenching), bad habits as heavy smoking and alcoholism.. Also patients with history of radiation therapy in the head and neck region
- Patients with contraindication for grafting procedures.
- Non cooperative patients neither who don't attend regular appointments nor following the instructions during construction procedures
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 |
|---|---|---|
| Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed ProsthesisSub-periosteal Implant Retaining Maxillary Fixed Prosthesis fabricated by digital \& milling technology | Other | CAD/CAM PEEK sub-periosteal implant retaining maxillary fixed prosthesis, Injection molding PEEK sub-periosteal implant retaining maxillary fixed prosthesis |
Primary outcome
Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis.
Time frame: 1 year
PEEK sub-periosteal implants were surgically placed. Probing depth was measured after three \& six months from sub-periosteal implant placement. Tumor necrosis factor-alpha (TNF-α) \& Interleukin-8(IL-8) Peri-abutment cervicular fluid were measured one month, three months , six months \& one year from sub-periosteal implant placement.
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 14 Jan 2022.
- 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.
Salah A. Hegazy, PhD study chair
salahhegazy2003@yahoo.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis in people with Mastication Disorder, run by Mansoura 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 0 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: finished, as of the sponsor's last update on 14 Jan 2022. 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?
Polyetheretherketone (PEEK) Sub-periosteal Implant Retaining Maxillary Fixed Prosthesis. (time frame: 1 year). 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 14 Jan 2022.