Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAZ Sint-Jan AV
About this trial
The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of all ages
Patients of all genders
Patients with a histologically or clinically confirmed diagnosis of ORN, MRONJ, as classified by Ruggiero et al. (Ruggiero, et al., 2014) or carcinoma located in the oral cavity and jawbone, requiring segmental or total jaw resection
Patients eligible for jaw and oral cavity reconstruction combined with immediate/delayed implant loading for fixed prosthetic rehabilitation
Disqualifiers
Patients with a clinically confirmed diagnosis of osteonecrosis not related to an oncological diagnosis or treatment
Patients with medical contraindications for jaw reconstruction combined with immediate implant loading for fixed prosthetic rehabilitation
Patients eligible for conventional removable prosthetic rehabilitation
Trial population
All consenting patients with a histologically confirmed oncology diagnosis that requires major ablative surgery of the oral cavity, including segmental or total jaw resection, due to head and neck cancer, ORN or MRONJ
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
implant survival rate
Time frame
within 12 months postoperative2
bone resorption, as evaluated with cone-beam computed tomography
Time frame
within 12 months postoperative3
prosthesis survival rate
Time frame
within 12 months postoperative4
implant survival rate
Time frame
within 60 months postoperativeSecondary outcomes
1
Prevalence of oncological patients requiring jaw reconstruction secondary to tumour resection, ORN or MRONJ
Time frame
within 12 months postoperative2
Potential biologic or mechanical risk factors predictive of undesirable functional or aesthetic outcomes, through regression analysis
Time frame
within 60 months postoperative3
Patient' quality of life after prosthetic rehabilitation
Time frame
until a maximum of 60 months follow-upOther outcomes
1
patient satisfaction, as measured through visual analogue scale
Time frame
until a maximum of 60 months follow-upSponsors and contacts
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Source ClinicalTrials.gov