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NCT Number: NCT02661139

Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction

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

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital Saint-John Bruges

Bruges, Belgium

Location status: Recruiting

Location contact

Araceli Diez-Fraile, PhD

CONTACT

[email protected]

About this study

The number of patients requiring major ablative surgery in the oral cavity, including partial/radical mandibular or maxillary resection, due to a head and neck carcinoma, osteoradionecrosis (ORN), or medication-related osteonecrosis of the jaw (MRONJ) has not been accurately reported. Surgical reconstruction to restore oral function and aesthetics forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). Recently, an active collaboration between the surgeons of the Oral and Maxillofacial Surgery Unit and the prosthodontist (LB) of the Department of Dentistry at the General Hospital Saint-John Bruges led to the development of the "Oncology-bridge (O-bridge)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time, consequently accelerating patient' improved QOL at a considerably reduced cost.

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 This could provide the investigators with more information about potential patient, surgical and prosthetic factors influencing short- and long-term biological and mechanical stability, as well as patient QOL. Moreover, registration of those results could function as a measurement of quality of care, and could be used for sample size calculation for future large prospective trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. implant survival rate

    Time frame: within 12 months postoperative

  2. bone resorption, as evaluated with cone-beam computed tomography

    Time frame: within 12 months postoperative

  3. prosthesis survival rate

    Time frame: within 12 months postoperative

  4. implant survival rate

    Time frame: within 60 months postoperative

  5. bone resorption, as evaluated with cone-beam computed tomography

    Time frame: within 60 months postoperative

  6. prosthesis survival rate

    Time frame: within 60 months postoperative

Secondary outcomes

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

    Time frame: within 12 months postoperative

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

    Time frame: within 60 months postoperative

  3. Patient' quality of life after prosthetic rehabilitation

    Time frame: until a maximum of 60 months follow-up

Other outcomes

  1. patient satisfaction, as measured through visual analogue scale

    Time frame: until a maximum of 60 months follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Araceli Diez-Fraile, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Acronym: O-BRIDGE

Important dates

Study start
2013
Primary completion
2022
Study completion
2027
First posted
Jan 22, 2016
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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