Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction

NCT02661139 | Recruiting

• 1 other identifier: B049201525496
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Cancer; Osteonecrosis; Osteoradionecrosis

Keywords

bisphosphonates; jaw reconstruction; prosthetic rehabilitation; quality of life; monoclonal antibodies' targeted therapy

Outcome Measures

Primary Outcomes (6)

• implant survival rate

  within 12 months postoperative

• bone resorption, as evaluated with cone-beam computed tomography

  within 12 months postoperative

• prosthesis survival rate

  within 12 months postoperative

• implant survival rate

  within 60 months postoperative

• bone resorption, as evaluated with cone-beam computed tomography

  within 60 months postoperative

• prosthesis survival rate

  within 60 months postoperative

Secondary Outcomes (3)

• Prevalence of oncological patients requiring jaw reconstruction secondary to tumour resection, ORN or MRONJ

  within 12 months postoperative

• Potential biologic or mechanical risk factors predictive of undesirable functional or aesthetic outcomes, through regression analysis

  within 60 months postoperative

• Patient' quality of life after prosthetic rehabilitation

  until a maximum of 60 months follow-up

Other Outcomes (1)

• patient satisfaction, as measured through visual analogue scale

  until a maximum of 60 months follow-up

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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
• Patients not eligible for conventional removable prosthetic rehabilitation

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

General Hospital Saint-John Bruges

Bruges, Belgium

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Osteonecrosis; Osteoradionecrosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Radiation Injuries; Wounds and Injuries

Study Officials

• Johan Abeloos, MD

  Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Araceli Diez-Fraile, PhD

CONTACT

araceli.diez-fraile@azsintjan.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maxillofacial surgeon, Head of Department

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 22, 2016
• Study Start: June 1, 2013
• Primary Completion: December 1, 2022
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)