Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implant; Mandibular Reconstruction; Free Tissue Flaps; Jaw Neoplasms
• Intervention / Treatment: Procedure: Simultaneous dental implantation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wing Shan Choi, PhD; Phone Number: +85228590363; Email: drwchoi@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince Philip Dental Hospital
    • Contact: Winnie Wing Shan Choi; Phone Number: 28590266; Email: drwchoi@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simultaneous dental implantation; To perform dental implantation simultaneously in free vascularized flap during jaw reconstruction	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of dental implant placements	Position of dental implant on CT scan compared to planned position	One month after surgery
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
Impact of oral health condition on quality of life	OHIP-14 questionnaire	6 months after surgery

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: dental implant; Maxillo-mandibular reconstruction; jaw neoplasms; free tissue flaps; Patient-specific titanium plates; virtual surgical planning
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Stomatognathic Diseases; Bone Diseases; Jaw Diseases; Skull Neoplasms; Bone Neoplasms; Jaw Neoplasms
• Other Study ID Numbers: UW21-341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No