Mandibular ReconstructionNCT05405179
Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction
A study testing Simultaneous dental implantation in people with Mandibular Reconstruction and Dental Implant, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Reconstruction, Dental Implant, Free Tissue Flaps
- What is being tested?
- Simultaneous dental implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2021to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince Philip Dental Hospital
Hong Kong
Winnie Wing Shan Choi, 28590266, drwchoi@hku.hk
About this study
Official title: 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.
Read the 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.
- Being tested
- Simultaneous dental implantation
- Keywords
- Maxillo-mandibular reconstruction, jaw neoplasms, free tissue flaps, dental implant, Patient-specific titanium plates, virtual surgical planning
- Medical subject headings
- Jaw Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous dental implantationProcedure or surgery
To perform dental implantation simultaneously in free vascularized bone flaps for jaw reconstruction using patient-specific surgical guides and titanium plates
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous dental implantation | Experimental | To perform dental implantation simultaneously in free vascularized flap during jaw reconstruction Receives: Procedure: Simultaneous dental implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Intraoperative
Secondary outcomes (3)
Accuracy of dental implant placements
Position of dental implant on CT scan compared to planned position
Measured: 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.
Measured: 6 months after surgery
Impact of oral health condition on quality of life
OHIP-14 questionnaire
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Sep 2021
- Primary completion28 Feb 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular ReconstructionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405179
- Sponsor's protocol ID
- UW21-341
- Status last verified
- May 2022
- First submitted
- 31 May 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction Using Patient-specific Surgical Guides and Titanium Plates: a Pilot Study
- ClinicalTrials.gov ID
- NCT05405179
- Acronym / sponsor ID
- UW21-341
- Keywords
- Maxillo-mandibular reconstruction, jaw neoplasms, free tissue flaps, dental implant, Patient-specific titanium plates, virtual surgical planning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simultaneous dental implantation | Experimental | Procedure: Simultaneous dental implantationTo perform dental implantation simultaneously in free vascularized flap during jaw reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous dental implantationTo perform dental implantation simultaneously in free vascularized bone flaps for jaw reconstruction using patient-specific surgical guides and titanium plates | Procedure or surgery | Simultaneous dental implantation |
Primary outcome
Intraoperative success rate
Time frame: Intraoperative
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)
3 secondary outcomes
Accuracy of dental implant placements
Time frame: One month after surgery
Implant survival
Time frame: 6 months after surgery
Impact of oral health condition on quality of life
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
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Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous dental implantation in people with Mandibular Reconstruction and Dental Implant, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wing Shan Choi, PhD (+85228590363, drwchoi@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative success rate (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.