Dental Implant Clinical Trial
Official title:
Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction Using Patient-specific Surgical Guides and Titanium Plates: a Pilot Study
After jaw resection, free vascularized bone flaps are frequently used for repairing maxillofacial defects. Simultaneous dental implantation is more preferable to secondary implantation as it saves the patients from going through a second surgery after recovering from the first one. In this study, the aim is to preliminarily evaluate the clinical outcome of simultaneous dental implants in vascularized bone flaps in jaw reconstruction using patient-specific surgical plates and 3-in-1-PSSG. The objectives of this study were: 1) to investigate the intraoperative success rate; 2) to measure the accuracy of dental implants position; and 3) to assess implant survival rate and postoperative adverse events.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | August 31, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age greater than 18 years, of both gender; 2. Diagnosed with maxillofacial benign or malignant pathology and indicated for jaw surgery with immediate dental implants; 3. Titanium plates and dental implants will be used in the surgery; 4. Agree to comply with follow-up procedures; 5. Provision of signed and dated informed consent form. Exclusion Criteria: 1. Patients who are pregnant; 2. Patients who need jaw reconstruction for the management of post-traumatic, congenital or developmental jaw deformities; 3. Patients who have medically compromised conditions and cannot tolerate the surgery; 4. Patients who are unable to have a two-week period prior to surgery, for virtual surgery simulation, patient-specific plates designing and fabrication; 5. Patients whose systemic conditions or diseases that violate the normal bone healing; 6. Patients who are unable to take the preoperative and postoperative CT/CBCT scans. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince Philip Dental Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative success rate | Success is defined as the uneventful placement of dental implant with adequate stability and correct angulation (Implant insertion torque value greater than 15Ncm and no implant thread exposure) | Intraoperative | |
Secondary | Accuracy of dental implant placements | Position of dental implant on CT scan compared to planned position | One month after surgery | |
Secondary | Implant survival | Implant that is retained in the reconstructed jaw at the time of examination, regardless of the state of the prosthesis. or patient satisfaction. | 6 months after surgery | |
Secondary | Impact of oral health condition on quality of life | OHIP-14 questionnaire | 6 months after surgery |
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