NCT05405179

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

July 19, 2022

Status Verified

May 1, 2022

Enrollment Period

2.5 years

First QC Date

May 31, 2022

Last Update Submit

July 14, 2022

Conditions

Mandibular ReconstructionDental ImplantFree Tissue FlapsJaw Neoplasms

Keywords

Maxillo-mandibular reconstructionjaw neoplasmsfree tissue flapsdental implantPatient-specific titanium platesvirtual surgical planning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Accuracy of dental implant placements

    One month after surgery

  • Implant survival

    6 months after surgery

  • Impact of oral health condition on quality of life

    6 months after surgery

Study Arms (1)

Simultaneous dental implantation

EXPERIMENTAL

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

Procedure: Simultaneous dental implantation

Interventions

Simultaneous dental implantationPROCEDURE

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

Simultaneous dental implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Philip Dental Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Jaw Neoplasms

Condition Hierarchy (Ancestors)

Skull NeoplasmsBone NeoplasmsNeoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesJaw DiseasesStomatognathic Diseases

Central Study Contacts

Wing Shan Choi, PhD

CONTACT

+85228590363drwchoi@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 6, 2022

Study Start

September 1, 2021

Primary Completion

February 28, 2024

Study Completion

August 31, 2024

Last Updated

July 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)