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Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction

Primary Purpose

Mandibular Reconstruction, Dental Implant, Free Tissue Flaps

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Simultaneous dental implantation
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Reconstruction focused on measuring Maxillo-mandibular reconstruction, jaw neoplasms, free tissue flaps, dental implant, Patient-specific titanium plates, virtual surgical planning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Prince Philip Dental HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Simultaneous dental implantation

Arm Description

To perform dental implantation simultaneously in free vascularized flap during jaw reconstruction

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Accuracy of dental implant placements
Position of dental implant on CT scan compared to planned position
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.
Impact of oral health condition on quality of life
OHIP-14 questionnaire

Full Information

First Posted
May 31, 2022
Last Updated
July 14, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05405179
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simultaneous dental implantation
Arm Type
Experimental
Arm Description
To perform dental implantation simultaneously in free vascularized flap during jaw reconstruction
Intervention Type
Procedure
Intervention Name(s)
Simultaneous dental implantation
Intervention Description
To perform dental implantation simultaneously in free vascularized bone flaps for jaw reconstruction using patient-specific surgical guides and titanium plates
Primary Outcome Measure Information:
Title
Intraoperative success rate
Description
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)
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Accuracy of dental implant placements
Description
Position of dental implant on CT scan compared to planned position
Time Frame
One month after surgery
Title
Implant survival
Description
Implant that is retained in the reconstructed jaw at the time of examination, regardless of the state of the prosthesis. or patient satisfaction.
Time Frame
6 months after surgery
Title
Impact of oral health condition on quality of life
Description
OHIP-14 questionnaire
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than 18 years, of both gender; Diagnosed with maxillofacial benign or malignant pathology and indicated for jaw surgery with immediate dental implants; Titanium plates and dental implants will be used in the surgery; Agree to comply with follow-up procedures; Provision of signed and dated informed consent form. Exclusion Criteria: Patients who are pregnant; Patients who need jaw reconstruction for the management of post-traumatic, congenital or developmental jaw deformities; Patients who have medically compromised conditions and cannot tolerate the surgery; Patients who are unable to have a two-week period prior to surgery, for virtual surgery simulation, patient-specific plates designing and fabrication; Patients whose systemic conditions or diseases that violate the normal bone healing; Patients who are unable to take the preoperative and postoperative CT/CBCT scans.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wing Shan Choi, PhD
Phone
+85228590363
Email
drwchoi@hku.hk
Facility Information:
Facility Name
Prince Philip Dental Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winnie Wing Shan Choi
Phone
28590266
Email
drwchoi@hku.hk

12. IPD Sharing Statement

Plan to Share IPD
No

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Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction

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