Clinical trial NCT05405179: Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction
Official title: Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction Using Patient-specific Surgical Guides and Titanium Plates: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mandibular Reconstruction
Dental Implant
Free Tissue Flaps
Jaw Neoplasms
Keywords: Maxillo-mandibular reconstruction
jaw neoplasms
free tissue flaps
dental implant
Patient-specific titanium plates
virtual surgical planning
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: After jaw resection, free vascularized bone flaps are frequently used for repairing maxillofacial defects. Owing to the extensive loss of dentition and soft tissues after the ablative surgery, the use of conventional fixed and removable prostheses is often limited in such cases. Implant-supported fixed prosthesis could be a better alternative which is free-standing and does not rely on tooth or soft tissue support. Dental implants on bone flaps restore the patient's oral function and comfort. 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.

However, conventional freehand immediate placement of dental implants in jaw reconstructive surgery is technically challenging as the position has to be highly precise to support an aesthetic and functional prosthesis. The current development of computer-aided surgery has been able to plan the inset of a vascularized bone flap in the maxillomandibular complex using digitally planned and printed surgical guides based on the patient's computed tomography (CT) data. The computer-aided surgery also facilitates the placement of dental implants at the optimal position and the modification of the bony reconstruction according to the implant position. Previously, the investigators have designed and fabricated novel patient-specific surgical plates by metal three- dimensional (3D) printing technology for jaw reconstruction, which led to precise reconstructive outcomes. In this study, the investigators propose a novel three-in-one patient-specific surgical guide (3-in-1-PSSG) which includes bone segmentation, surgical plate and implant placement positioning functions, to facilitate simultaneous dental implants in vascularized bone flap jaw reconstruction. It is hypothesized that the 3-in-1-PSSG simplifies the surgical procedure. Together with the patient-specific titanium plate, the clinical outcomes for simultaneous dental implants in jaw reconstruction with vascularized bone flap will be improved.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraoperative success rate
timeFrame: Intraoperative
Secondary outcomes:
measure: Accuracy of dental implant placements
timeFrame: One month after surgery
measure: Implant survival
timeFrame: 6 months after surgery
measure: Impact of oral health condition on quality of life
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince Philip Dental Hospital
Study officials:
References: