Validation of the O-bridge Protocol: a Prospective, Multicenter Trial

Quality of Life Clinical Trial

Official title:

Validation of the O-bridge Protocol, Ensuring Immediate or Delayed Prosthetic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction: a Prospective, Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04007783
• Other study ID #: B322201731284
• Status: Recruiting
• Start date: March 4, 2017
• Est. completion date: December 2027

Study information

• Verified date: February 2022
• Source: AZ Sint-Jan AV
• Contact: Araceli Diez-Fraile, PhD
• Phone: 0032(0)50459660
• Email: araceli.diez-fraile[@]azsintjan.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Surgical reconstruction to restore oral function and aesthetics after major ablative surgery in the oral cavity forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). The "Oncological-bridge (O-bridge®)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time.

Description:

Surgical reconstruction to restore oral function and aesthetics after major ablative surgery in the oral cavity forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). The "Oncological-bridge (O-bridge®)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time.

Objective: The investigators aim to demonstrate the added value of the "O-bridge® protocol" in a larger sample size of at least 20 patients eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity (mandibular) reconstruction study design: a prospective, observational cohort study. The "O-bridge® protocol", in which the standardized concept of implant loading and that of oral cavity (mandibular) reconstruction are combined with an adapted prosthetic manufacturing protocol, will be offered to eligible patients requiring ablative surgery because of a benign or malignant tumour of the oral cavity or stage 3-4 osteonecrosis.

All patients will be screened by the local maxillofacial surgeon and the prosthodontist to determine eligibility for the procedure. Imaging will be performed as part of routine surgical preparation. Clinical function, as measured with the 11-item scale by Rogers and intelligibility of speech will be assessed by the speech therapist and/or appointed health care employee prior to surgery, 3 months post-surgery and/or at time of implant placement, and at 6 weeks after placement of the O-bridge®. In addition, EORTC quality of life C30 and HN35 questionnaires will also be completed at those time-points, and at 6 months after placement of the O-bridge®. Speech-, food- and prosthetic fit-related items from the Oral Health Impact Profile (OHIP) questionnaire will be completed at 6 weeks and at 6 months after placement of the O-bridge®. Parameters related to implant and bridge stability and patient satisfaction, measured through a 10-point visual analogue scale, will be assessed at 6, 12, 24, 36, 48 and 60 months at routine follow-up consultation after placement of the O-bridge®.

As a primary endpoint, the investigators aim to demonstrate that the O-bridge® protocol significantly improves short-term patient' quality of life.

Moreover, the investigators aim to demonstrate the validity and reliability of the O-bridge® protocol, based on its short- and long-term biologic implant stability and mechanical stability of the prosthesis. In addition, they aim to measure the impact of the O-bridge® on speech intelligibility.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2027
• Est. primary completion date: December 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a histologically or clinically confirmed diagnosis of ORN, MRONJ, as classified by respectively Lyons et al. (Lyons, et al., 2014) and Ruggiero et al. (Ruggiero, et al., 2009) (Ruggiero, et al., 2014) or a benign or malignant tumour located in the oral cavity and jaw bone (NCCN, 2015) (Sobin, et al., 2009), requiring marginal, 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 not eligible to the abovementioned 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 whose maternal language is non-Dutch or non-English will be excluded from the acoustic speech evaluation. A perceptual evaluation of speech intelligibility can still be performed.

Related Conditions & MeSH terms

• Benign or Malignant Tumour of the Oral Cavity
• Fixed Dental Restoration
• Mandibular Reconstruction
• Neoplasms
• Osteonecrosis
• Quality of Life
• Stage III-IV Osteonecrosis

Locations

Country	Name	City	State
Belgium	Ziekenhuis Netwerk Antwerpen	Antwerp
Belgium	ZMACK association - Antwerp University Hospital	Antwerp
Belgium	Division of Oral and Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV	Bruges
Belgium	University Hospital Leuven	Leuven
Belgium	AZ Nikolaas	Sint-Niklaas

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EORTC QLQ C30, for measurement of quality of life	short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ C30 questionnaire	6 weeks after O-bridge placement
Primary	EORTC QLQ H&N35, for measurement of quality of life	short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ HN35 questionnaire	6 weeks after O-bridge placement
Primary	EORTC QLQ C30, for measurement of quality of life	short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ C30	6 months after O-bridge placement
Primary	EORTC QLQ H&N35, for measurement of quality of life	short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ HN35	6 months after O-bridge placement
Primary	OHIP, for measurement of quality of life	short-term quality of life after dental restoration with the O-bridge, measured through the OHIP questionnaire	6 weeks after O-bridge placement
Primary	OHIP, for measurement of quality of life	short-term quality of life after dental restoration with the O-bridge, measured through the OHIP questionnaire	6 months after O-bridge placement
Secondary	percentage of patients with marginal bone loss around implants	short-term biologic implant stability, measured through OPG imaging	until one year post implantation
Secondary	percentage of patients with marginal bone loss around implants	long-term biologic implant stability, measured through OPG imaging	until five years post implantation
Secondary	percentage of patients with mechanical stability problems of the prosthesis	short-term, measured through clinical evaluation	until one year post implantation
Secondary	percentage of patients with mechanical stability problems of the prosthesis	long-term, measured through clinical evaluation	until five years post implantation
Secondary	percentage of patients with difficulties in speech intelligibility	impact of the O-bridge on speech intelligiblity, measured through reading of a predefined oronasal text interpreted by the speech and language pathologist	prior to and 6 weeks post O-bridge