None listed
Conditions
Brief summary
This study aims to compare the costs and overall value of jaw-in-a-day (JIAD) surgery with the standard approach, where teeth are replaced some-time after jaw reconstruction surgery. Who is it for? You may be eligible for this study if you are male or female, aged 18 years or older undergoing jaw reconstruction with an osseous free flap, suitable for dental implant placement, with American Society of Anesthesiologists (ASA) score I-III, and able to self-care and maintain good dental hygiene. Study details Participants who choose to enrol in this study will be randomised to either JIAD or standard jaw reconstruction. JIAD involves replacing the missing teeth at the same time as the jaw reconstruction surgery, instead of the standard approach where teeth are replaced some-time after jaw reconstruction surgery. The Head and Neck Reconstructive surgery is planned and will take 6-10 hours (standard of care). After surgery, participants will attend routine outpatient clinic visits, and CT scans will be collected every three months for the first year as part of standard care. Will also complete questionnaires at the above time points. In the second year, this process will continue every six months. It is hoped this research will help others in the future who may benefit from gathering new information about the cost and value of different ways of replacing missing teeth after the jaw reconstruction.
Interventions
The study involves replacing the missing teeth at the same time as the jaw reconstruction surgery. This type of surgery is called jaw-in-a-day (JIAD) surgery. The aim of this study is to compare the costs and overall value of jaw-in-a-day surgery with the standard approach, where teeth are replaced some-time after jaw reconstruction surgery.
Intervention: Jaw-In-A-Day (JIAD) Surgery
At the time of surgery (6-10 hours)
-Dental implant placement
-Provisional prosthesis placement
After the surg
The study involves replacing the missing teeth at the same time as the jaw reconstruction surgery. This type of surgery is called jaw-in-a-day (JIAD) surgery. The aim of this study is to compare the costs and overall value of jaw-in-a-day surgery with the standard approach, where teeth are replaced some-time after jaw reconstruction surgery. Intervention: Jaw-In-A-Day (JIAD) Surgery At the time of surgery (6-10 hours) -Dental implant placement -Provisional prosthesis placement After the surgery -Provisional prosthesis modification or interim prosthesis placement -Definitive prosthesis placement At a preoperative appointment with the surgeon for reconstructive surgery, participants will answer a quality-of-life questionnaire, which will take approximately 10-15minutes. The Head and Neck Reconstructive surgery is planned and will take 6-10 hours (standard of care) After surgery, participants will attend routine outpatient clinic visits, and CT scans will be collected every three months for the first year as part of standard care. Will also complete questionnaires (about 15 minutes each) at the above time points. In the second year, this process will continue every six months. Post Operative CT scans will be compared with the virtual surgical plan to assess fidelity to the intervention.
Sponsors
Chris O'Brien Lifehouse
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. over 18 years of age undergoing jaw reconstruction with an osseous free flap. 2. Suitable for dental implant placement. 3. American Society of Anesthesiologists (ASA) score I-III. 4. Able to self-care and maintain good dental hygiene.
Exclusion criteria
1. be immunosuppressed (equivalent to > 5mg of Prednisone daily) 2. have uncontrolled diabetes (consistently elevated blood glucose level HbA1c > 7.0% and presence of acute complications such as diabetic ketoacidosis or hyperosmolarity)
Outcome results
None listed