Ridge AugmentationNCT05624697
Assessment of Digital and Clinical Workflow Using Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla: A Case Series
A study testing sticky bone housed in PEEK Shell in people with Ridge Augmentation, run by Cairo University at 1 site in Egypt.
Trial summary
10 Patients having horizontally deficient anterior maxillary areas will be recruited and a preoperative CBCT will be done. The plan is to graft the defective ridges with simultaneously placing dental implants using a PEEK shell that will be specifically designed, constructed and 3D printed to act as a surgical guide… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ridge Augmentation
- What is being tested?
- sticky bone housed in PEEK Shell
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2022to 25 May 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with Multiple missing Maxillary Anterior Teeth with horizontally defective ridges having adequate soft tissue ample.
- Patients who already gave their consent for this trial.
- Males and females both will be included.
Who cannot join
- Patients on bisphosphonates or drugs altering bone metabolism, within 2 months before initiating the study.
- Subjected to irradiation in the head and neck region within the last year
- Patients allergic to drugs used in the study like ( Articaine, Lidocaine,
- Patients having a history of a major medical condition (ASA 3,4)
- Untreated periodontitis.
- Poor oral hygiene and motivation.
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- Uncontrolled diabetes.
- Pregnant or nursing.
- Substance abuse.
- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Immunosuppressed or immunocompromised.
- Treated or under treatment with intravenous amino-bisphosphonates.
- Active infection or severe inflammation in the area intended for implant placement.
- Unable to open mouth sufficiently to accommodate the surgical tooling.
- Patients participating in other studies, if the present protocol could not be properly followed.
- Referred only for implant placement or unable to attend a 5-year follow-up.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo, 11553
About this study
10 Patients having horizontally deficient anterior maxillary areas will be recruited and a preoperative CBCT will be done. The plan is to graft the defective ridges with simultaneously placing dental implants using a PEEK shell that will be specifically designed, constructed and 3D printed to act as a surgical guide for osteotomy drilling and implant placement as well as housing both the implant and the sticky bone (using a mixture of autogenous bone harvested from the symphysis area and xenograft both mixed with plasmatic matrix); that will be added to augment the defective ridge; the PEEK shell will also act as a barrier membrane for Guided Bone Regeneration and will add more stability to the placed implants that will be fixed to the PEEK shell occlusally with a Ti - based abutment.
Primary stability will be measured using Ostell and an immediate postoperative CBCT will be done and superimposed on the preoperative CBCT and an accuracy of plan transfer will be measured to make sure the planning was followed accurately.
Then 6 months later, another CBCT will be done to check the bone gain and quality and a second surgery will be done to remove the PEEK shell and proceed with the conventional implant prosthetic phase.
- Conditions
- Ridge Augmentation
- Being tested
- sticky bone housed in PEEK Shell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sticky bone housed in PEEK ShellProcedure or surgery
Patient specific Sticky Bone/Implant housing PEEK shell in Anterior Atrophic Maxilla
| Study group | Role | What they receive |
|---|---|---|
| Augmented group | Other | Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla with simultaneous implant placement Receives: Procedure: sticky bone housed in PEEK Shell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone gain
Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone gain in mm
Measured: T0 before surgery, T1 immediately after surgery and T2 after 6 months
Secondary outcomes (3)
Clinically successful osseointegrated implant
measuring primary stability immediately after implant placement and in the second surgery using Ostell device
Measured: At the day of the surgery and 6 months after first surgery
Accuracy of Plan Transfer
superimposing the preoperative CBCT and the immediately postoperative CBCT to measure the accuracy of the procedure compared to the plan done
Measured: 1-3 days postoperatively
Bone Quality
Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone quality in Hounsfield units
Measured: 0 before surgery, T1 immediately after surgery and T2 after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start25 Nov 2022 (estimated)
- Primary completion25 Nov 2023 (estimated)
- Study completion25 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge AugmentationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Samy Bahgat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624697
- Sponsor's protocol ID
- 16722
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Digital and Clinical Workflow Using Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla: A Case Series
- ClinicalTrials.gov ID
- NCT05624697
- Acronym / sponsor ID
- 16722
- Conditions
- Ridge Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Nov 2022 (estimated)
- Primary completion
- 25 Nov 2023 (estimated)
- Study completion
- 25 May 2024 (estimated)
- First posted
- 22 Nov 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.
10 Patients having horizontally deficient anterior maxillary areas will be recruited and a preoperative CBCT will be done. The plan is to graft the defective ridges with simultaneously placing dental implants using a PEEK shell that will be specifically designed, constructed and 3D printed to act as a surgical guide for osteotomy drilling and implant placement as well as housing both the implant and the sticky bone (using a mixture of autogenous bone harvested from the symphysis area and xenograft both mixed with plasmatic matrix); that will be added to augment the defective ridge; the PEEK shell will also act as a barrier membrane for Guided Bone Regeneration and will add more stability to the placed implants that will be fixed to the PEEK shell occlusally with a Ti - based abutment.
Primary stability will be measured using Ostell and an immediate postoperative CBCT will be done and superimposed on the preoperative CBCT and an accuracy of plan transfer will be measured to make sure the planning was followed accurately.
Then 6 months later, another CBCT will be done to check the bone gain and quality and a second surgery will be done to remove the PEEK shell and proceed with the conventional implant prosthetic phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmented group | Other | Procedure: sticky bone housed in PEEK ShellPatient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla with simultaneous implant placement |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with Multiple missing Maxillary Anterior Teeth with horizontally defective ridges having adequate soft tissue ample.
- Patients who already gave their consent for this trial.
- Males and females both will be included.
Key exclusion criteria (17 listed)
- Patients on bisphosphonates or drugs altering bone metabolism, within 2 months before initiating the study.
- Subjected to irradiation in the head and neck region within the last year
- Patients allergic to drugs used in the study like ( Articaine, Lidocaine,
- Patients having a history of a major medical condition (ASA 3,4)
- Untreated periodontitis.
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 |
|---|---|---|
| sticky bone housed in PEEK ShellPatient specific Sticky Bone/Implant housing PEEK shell in Anterior Atrophic Maxilla | Procedure or surgery | Augmented group |
Primary outcome
Bone gain
Time frame: T0 before surgery, T1 immediately after surgery and T2 after 6 months
Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone gain in mm
3 secondary outcomes
Clinically successful osseointegrated implant
Time frame: At the day of the surgery and 6 months after first surgery
Accuracy of Plan Transfer
Time frame: 1-3 days postoperatively
Bone Quality
Time frame: 0 before surgery, T1 immediately after surgery and T2 after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sticky bone housed in PEEK Shell in people with Ridge Augmentation, run by Cairo 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 3 inclusion and 17 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 22 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed MS Bahgat, BDS (01007419224 ext. 002, mohamed.samy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone gain (time frame: T0 before surgery, T1 immediately after surgery and T2 after 6 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 22 Nov 2022.