Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05405179
• Other study ID #: UW21-341
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2022
• Source: The University of Hong Kong
• Contact: Wing Shan Choi, PhD
• Phone: +85228590363
• Email: drwchoi[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dental Implant
• Free Tissue Flaps
• Mandibular Reconstruction

Intervention

Procedure:
• Simultaneous dental implantation
To perform dental implantation simultaneously in free vascularized bone flaps for jaw reconstruction using patient-specific surgical guides and titanium plates

Locations

Country	Name	City	State
Hong Kong	Prince Philip Dental Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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