Assessment of Digital and Clinical Workflow Using Patient Specific Sticky Bone /Implant Housing P… (NCT05624697) | Clinical Trial Compass
UnknownNot Applicable
Assessment of Digital and Clinical Workflow Using Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla: A Case Series
Egypt10 participantsStarted 2022-11-25
Plain-language 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 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone gain
Timeframe: T0 before surgery, T1 immediately after surgery and T2 after 6 months