## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** UW21-341
#### Organization
**Class:** OTHER
**Full Name:** The University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-07-19

**Type:** ACTUAL

**Last Update Submit Date:** 2022-07-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-02-28

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-09-01

**Type:** ACTUAL

**Status Verified Date:** 2022-05

#### Study First Post Date
**Date:** 2022-06-06
**Type:** ACTUAL
**Study First Submit Date:** 2022-05-31
**Study First Submit QC Date:** 2022-05-31
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Hong Kong

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 25

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Simultaneous dental implantation

**Label:** Simultaneous dental implantation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Simultaneous dental implantation

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

**Name:** Simultaneous dental implantation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**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)

**Measure:** Intraoperative success rate

**Time Frame:** Intraoperative

#### Secondary Outcomes

**Description:** Position of dental implant on CT scan compared to planned position

**Measure:** Accuracy of dental implant placements

**Time Frame:** One month after surgery

**Description:** Implant that is retained in the reconstructed jaw at the time of examination, regardless of the state of the prosthesis. or patient satisfaction.

**Measure:** Implant survival

**Time Frame:** 6 months after surgery

**Description:** OHIP-14 questionnaire

**Measure:** Impact of oral health condition on quality of life

**Time Frame:** 6 months after surgery

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drwchoi@hku.hk

**Name:** Wing Shan Choi, PhD

**Phone:** +85228590363

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hong Kong

**Contacts:**

***Contact 1:***

- **Email:** drwchoi@hku.hk

- **Name:** Winnie Wing Shan Choi

- **Phone:** 28590266

- **Role:** CONTACT

**Country:** Hong Kong

**Facility:** Prince Philip Dental Hospital

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000012888

- Term: Skull Neoplasms

- ID: D000001859

- Term: Bone Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000007571

- Term: Jaw Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10603

- Name: Jaw Neoplasms

- Relevance: HIGH

- As Found: Jaw Neoplasms

- ID: M15691

- Name: Skull Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5138

- Name: Bone Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10601

- Name: Jaw Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007573

- Term: Jaw Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
