Neoplasm, OralJaW PrinTNCT03905005
Jaw Reconstruction With Printed Titanium and Free Tissue Transfer
An observational study of Neoplasm, Oral and Osteoradionecrosis of Jaw, run by University of South Wales at 1 site in United Kingdom.
Trial summary
JaW PrinT is a prospective observational cohort study evaluating the effectiveness of two different techniques of mandibular reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm, Oral, Osteoradionecrosis of Jaw, Mandibular Diseases
- What is being tested?
- Mandibular reconstruction with free tissue transfer.
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Mar 2018to 1 Oct 2021
- Phase
- Observational
- 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
Study population: Patients from the study site region requiring free-flap reconstruction of the mandible (e.g. for tumour or osteoradionecrosis):
Who may be able to join
- Age over 18 years
- Able to provide informed consent
- A planned fibular free-flap reconstruction of the mandible
- Planned post operative surveillance CT scan 6 months following surgery
Who cannot join
- Clinically unfit or inappropriate (based upon prognosis/life expectancy) for reconstruction using free tissue transfer techniques
- Patients with planned surgical defects involving formal reconstruction of the condyle. (Clinical use of printed plates for condylar reconstructions would in effect be 'off-licence' and non-standard treatment which is beyond the remit of an observational research study).
- Flap failure within the study follow-up period, as this would require early removal of the flap and therefore preclude collection of follow-up outcome data. However, any flap failures (and associated clinical complications/events) will be recorded and reported.
Trial locations and contacts
1 site in 1 country.
About this study
JaW PrinT is a prospective observational cohort study evaluating the effectiveness of two different techniques of mandibular reconstruction.
Read the detailed description
JaW PrinT is a 'real-world' prospective observational pilot study, evaluating the clinical effectiveness, usability and economics of two approaches to mandibular reconstruction surgery (using flexed titanium versus printed titanium patient-specific osseosynthesis plates). Patient participants will be recruited prospectively over a minimum period of 18 months (with observation of at least 10 participants in each treatment pathway). The figures are based upon the historical clinical practice of the research site, with both techniques in equal use; choice depending on resources, surgical training requirements and surgeon's clinical preference.
As a purely observational study, treatment choice will be made in the normal clinical manner and will in no way be influenced by the study itself.
Participants will be followed up at their routine outpatient clinics (6 weeks, 6 months and 1 year postoperatively) with prospective outcomes data collection.
Participants will be recruited prospectively as they present as new patient cases to the Maxillofacial and Head \& Neck cancer multidisciplinary team (MDT) clinics. Once a potential patient participant has been given his/her diagnosis and it is confirmed by the principal investigator (PI) that he/she meets the inclusion criteria, clinic staff will provide the potential participant with an invitation letter introducing the study as well as a patient information sheet and consent form (explaining the available options of participating or refraining from the study). Patients will be allowed up to 24 hours to decide whether or not to participate as to avoid any impact/delay on the scheduling of their clinical treatment. The PI will obtain written informed consent from willing participants.
Upon recruitment, provision of informed consent and collection of baseline data, as per standard clinical practice, the patient participant's CT scan data is used to produce a virtual surgical plan for the mandibular resection and fibular free-flap reconstruction. Once the clinically optimal reconstructive surgical plan is established by the surgeon and technician, the choice of surgical approach will be made in the routine clinical manner by the surgeon: Pathway A (pre-flexed customized mandibular reconstruction plate and cutting guides) or to pathway B (SLM customized mandibular reconstruction plate and cutting guides). Both treatment pathways are already part of routine/standard clinical practice at the research site.
The expected/planned patient numbers for this study are based upon the historical workload of the department, typically at 10-20 cases annually. A recruitment period of 18 months with follow-up for 1 year fits within the time constraints of the postgraduate student investigator's PhD timeline.
- Conditions
- Neoplasm, Oral, Osteoradionecrosis of Jaw, Mandibular Diseases, Jaw Cancer, Jaw Diseases, Surgery
- Being tested
- Mandibular reconstruction with free tissue transfer.
- Medical subject headings
- Mouth Neoplasms, Mandibular Diseases, Jaw Neoplasms, Jaw Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular reconstruction with free tissue transfer.Procedure or surgery
Mandibular reconstruction with free tissue transfer (free-flap bony reconstruction) requires the use of a titanium plate to secure bony segments until bony healing is complete. Plates are made of titanium but can be customised to the anatomical shape of the mandible by two different techniques: flexing (bending) of the plate before surgery, or printing of the plate from titanium alloy powder bed fusion techniques (additive manufacturing, such as selective laser melting).
| Study group | Role | What they receive |
|---|---|---|
| Pre-flexed reconstruction plate | Patients who undergo mandibular reconstruction using a pre-flexed osseosynthesis reconstruction plate along with free-tissue transfer for reconstruction of a mandibular continuity defect. Receives: Procedure: Mandibular reconstruction with free tissue transfer. | |
| Printed reconstruction plate | Patients who undergo mandibular reconstruction using a 3D-printed reconstruction plate made by selective laser melting (SLM), along with free-tissue transfer for reconstruction of a mandibular continuity defect. Receives: Procedure: Mandibular reconstruction with free tissue transfer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimensional accuracy
Dimensional accuracy of the bony reconstruction, as demonstrated by comparing 6 months postoperative CT scan DICOM data with a presurgical digital surgical plan.
Measured: 6 months
Secondary outcomes (10)
Duration of surgery
The impact of surgical technique (pathway A or B) on the duration of insetting the bony flap into the mandibular continuity defect.
Measured: 1 day (day of surgery)
Operator's rating of usability/confidence/satisfaction with technique
Using 5 point Likert scale ratings of ease of flap preparation, ease of locating the reconstruction plate on the fibula, confidence with technique, ease of mandibular reconstruction, ease of locating the reconstruction plate on the mandible, bony apposition of fibula-fibula and fibula-mandible osteotomies as planned, satisfaction with morphology of reconstructed mandible, confidence with technique overall (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree).
Measured: 1 day (day of surgery)
Need to make adjustments to reconstructive surgical plan intraoperatively
List of all required adjustments to the planned reconstructive surgical procedure (e.g. trimming of osteotomies etc.) are recorded.
Measured: 1 day (day of surgery)
Complications
Incidence of intra/peri/post-operative complications are recorded (e.g. infection, plate exposure, prolonged hospital stay, non-union etc.)
Measured: 1 year postoperatively
Qualitative evaluation of dental occlusal relationship and feasibility of dental implant rehabilitation
Qualitative Evaluation of changes in dental occlusion by evaluating dental plaster of Paris models (presence or absence of "malocclusion" pre and post-operatively) PLUS assessment/rating of feasibility of dental implant rehabilitation in relation to actual bony reconstruction using a 5 point likert scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree)
Measured: 1 year postoperatively
Patient reported quality of life relating to appearance
Subjective scoring of patient's own perceptions of their quality of life relating to their appearance using the Derriford Appearance Scale
Measured: Baseline, 6 weeks, 6 months, 1 year postoperatively
Patient perceived quality of life relating to mood
University of Washington v4.0 questionnaire score.
Measured: Baseline, 6 weeks, 6 months, 1 year postoperatively
Financial implications of surgical technique
Evaluation of cost differences (if any) between patient groups
Measured: Separately for duration of inpatient hospital stay (typically 2 weeks) and for the total 1 year study follow-up period (from identification of participant to completion of patient's participation).
Patient perceived quality of life relating to oral function
Liverpool oral rehabilitation questionnaire scores.
Measured: Baseline, 6 weeks, 6 months, 1 year postoperatively
objective quantitative evaluation of facial symmetry
stereophotogrammetry to assess facial symmetry.
Measured: Baseline, 6 weeks, 6 months, 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start12 Mar 2018
- Primary completion1 Apr 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm, OralStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M Williams, PhD, Study chair, University of South WalesA Goodson, MBBS, Study director, University of South WalesM Kittur, MBBS, Principal investigator, Morriston Hospital, ABMU Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905005
- Sponsor's protocol ID
- 241919
- Other IDs
- 38098
- Acronym
- JaW PrinT
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2019
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jaw Reconstruction With Printed Titanium and Free Tissue Transfer
- ClinicalTrials.gov ID
- NCT03905005
- Acronym / sponsor ID
- JaW PrinT / 241919
- Conditions
- Neoplasm, Oral, Osteoradionecrosis of Jaw, Mandibular Diseases, Jaw Cancer, Jaw Diseases, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of South WalesUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 5 Apr 2019 (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.
JaW PrinT is a prospective observational cohort study evaluating the effectiveness of two different techniques of mandibular reconstruction.
Detailed description
JaW PrinT is a 'real-world' prospective observational pilot study, evaluating the clinical effectiveness, usability and economics of two approaches to mandibular reconstruction surgery (using flexed titanium versus printed titanium patient-specific osseosynthesis plates). Patient participants will be recruited prospectively over a minimum period of 18 months (with observation of at least 10 participants in each treatment pathway). The figures are based upon the historical clinical practice of the research site, with both techniques in equal use; choice depending on resources, surgical training requirements and surgeon's clinical preference.
As a purely observational study, treatment choice will be made in the normal clinical manner and will in no way be influenced by the study itself.
Participants will be followed up at their routine outpatient clinics (6 weeks, 6 months and 1 year postoperatively) with prospective outcomes data collection.
Participants will be recruited prospectively as they present as new patient cases to the Maxillofacial and Head \& Neck cancer multidisciplinary team (MDT) clinics. Once a potential patient participant has been given his/her diagnosis and it is confirmed by the principal investigator (PI) that he/she meets the inclusion criteria, clinic staff will provide the potential participant with an invitation letter introducing the study as well as a patient information sheet and consent form (explaining the available options of participating or refraining from the study). Patients will be allowed up to 24 hours to decide whether or not to participate as to avoid any impact/delay on the scheduling of their clinical treatment. The PI will obtain written informed consent from willing participants.
Upon recruitment, provision of informed consent and collection of baseline data, as per standard clinical practice, the patient participant's CT scan data is used to produce a virtual surgical plan for the mandibular resection and fibular free-flap reconstruction. Once the clinically optimal reconstructive surgical plan is established by the surgeon and technician, the choice of surgical approach will be made in the routine clinical manner by the surgeon: Pathway A (pre-flexed customized mandibular reconstruction plate and cutting guides) or to pathway B (SLM customized mandibular reconstruction plate and cutting guides). Both treatment pathways are already part of routine/standard clinical practice at the research site.
The expected/planned patient numbers for this study are based upon the historical workload of the department, typically at 10-20 cases annually. A recruitment period of 18 months with follow-up for 1 year fits within the time constraints of the postgraduate student investigator's PhD timeline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-flexed reconstruction plate | – | Procedure: Mandibular reconstruction with free tissue transfer.Patients who undergo mandibular reconstruction using a pre-flexed osseosynthesis reconstruction plate along with free-tissue transfer for reconstruction of a mandibular continuity defect. |
| Printed reconstruction plate | – | Procedure: Mandibular reconstruction with free tissue transfer.Patients who undergo mandibular reconstruction using a 3D-printed reconstruction plate made by selective laser melting (SLM), along with free-tissue transfer for reconstruction of a mandibular continuity defect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the study site region requiring free-flap reconstruction of the mandible (e.g. for tumour or osteoradionecrosis):
Key inclusion criteria (4 listed)
- Age over 18 years
- Able to provide informed consent
- A planned fibular free-flap reconstruction of the mandible
- Planned post operative surveillance CT scan 6 months following surgery
Key exclusion criteria (3 listed)
- Clinically unfit or inappropriate (based upon prognosis/life expectancy) for reconstruction using free tissue transfer techniques
- Patients with planned surgical defects involving formal reconstruction of the condyle. (Clinical use of printed plates for condylar reconstructions would in effect be 'off-licence' and non-standard treatment which is beyond the remit of an observational research study).
- Flap failure within the study follow-up period, as this would require early removal of the flap and therefore preclude collection of follow-up outcome data. However, any flap failures (and associated clinical complications/events) will be recorded and reported.
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 |
|---|---|---|
| Mandibular reconstruction with free tissue transfer.Mandibular reconstruction with free tissue transfer (free-flap bony reconstruction) requires the use of a titanium plate to secure bony segments until bony healing is complete. Plates are made of titanium but can be customised to the anatomical shape of the mandible by two different techniques: flexing (bending) of the plate before surgery, or printing of the plate from titanium alloy powder bed fusion techniques (additive manufacturing, such as selective laser melting). | Procedure or surgery | Pre-flexed reconstruction plate, Printed reconstruction plate |
Primary outcome
Dimensional accuracy
Time frame: 6 months
Dimensional accuracy of the bony reconstruction, as demonstrated by comparing 6 months postoperative CT scan DICOM data with a presurgical digital surgical plan.
10 secondary outcomes
Duration of surgery
Time frame: 1 day (day of surgery)
Operator's rating of usability/confidence/satisfaction with technique
Time frame: 1 day (day of surgery)
Need to make adjustments to reconstructive surgical plan intraoperatively
Time frame: 1 day (day of surgery)
Complications
Time frame: 1 year postoperatively
Qualitative evaluation of dental occlusal relationship and feasibility of dental implant rehabilitation
Time frame: 1 year postoperatively
Patient reported quality of life relating to appearance
Time frame: Baseline, 6 weeks, 6 months, 1 year postoperatively
Patient perceived quality of life relating to mood
Time frame: Baseline, 6 weeks, 6 months, 1 year postoperatively
Financial implications of surgical technique
Time frame: Separately for duration of inpatient hospital stay (typically 2 weeks) and for the total 1 year study follow-up period (from identification of participant to completion of patient's participation).
Patient perceived quality of life relating to oral function
Time frame: Baseline, 6 weeks, 6 months, 1 year postoperatively
objective quantitative evaluation of facial symmetry
Time frame: Baseline, 6 weeks, 6 months, 1 year postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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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.
M Williams, PhD study chair
University of South Wales
A Goodson, MBBS study director
University of South Wales
M Kittur, MBBS principal investigator
Morriston Hospital, ABMU Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm, Oral and Osteoradionecrosis of Jaw, run by University of South Wales at 1 site in United Kingdom.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 25 Mar 2025. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dimensional accuracy (time frame: 6 months). 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 25 Mar 2025.