Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAO Innovation Translation Center

About this trial

Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The study includes patients with an initial pathological/histologic diagnosis of mandibular involvement by oral tumors (such as OSCC, osteosarcoma, and ameloblastoma), bisphosphonate- or immunomodulatory drug-induced osteonecrosis, and mandibular lesions from metastatic conditions originating from other sites including lung, breast, prostate, or kidney.

Age 18 years and older

Bisphosphonate related osteonecrosis of the mandible

Immunomodulatory drugs induced mandibular osteonecrosis

Disqualifiers

Tumors affecting the condyle

Patients under palliative care

Previous extensive mandibular surgeries (including reconstructions, e.g., TMJ replacement) that may potentially confound the outcome measures

Nonsegmental mandibular defect (eg. box resection/partial resection)

Trial population

Patients presenting with an acquired segmental mandibular defect secondary to oral squamous cell carcinoma removal and who require mandibular reconstruction.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Surgical Resection and Reconstruction

    Procedure/Surgery

    One stage reconstruction: Osseous reconstruction is performed in the same surgery of the tumor/mandibular resection. It is also known as immediate or primary reconstruction. Second stage reconstruction: Osseous reconstruction is performed after the tumor/mandibular resection surgery as an independent surgery. After the mandibular resection a temporary alloplastic bridging might be put in place. It is also known as delayed or secondary reconstruction.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Mandibular Reconstruction1 intervention

Trial outcomes

Primary outcomes

1

Demographics

Demographics (year of birth, height in cm and weight in kilogram, race)

Time frame
Baseline until resection surgery approximately 4 weeks
2

Comorbidities

Comorbidities assessed by Charlson Comorbidity Index (this score assesses the comorbidity level by considering both the number and severity of predefined comorbidity conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates

Time frame
Baseline until resection surgery approximately 4 weeks
3

Nicotine consumption

Current and previous nicotine use will be collected: * Number of years * Time (years) since stopped using (if applicable) * Amount of cigarettes/day

Time frame
Baseline until resection surgery approximately 4 weeks
4

Patient reported outcome: Oral Health Impact Profile (OHIP)

Change in the OHIP over the follow-up period. The Oral Health Impact Profile is providing a comprehensive measure of self-reported dysfunction, discomfort and disability attributed to oral conditions. The OHIP is concerned with impairment and three functional status dimensions (social, psychological, and physical). Respondents are asked to indicate on a five-point Likert scale how frequently they experienced each problem. Response categories for the five-point scale are: "Very often", "Fairly often", "Occasionally", "Hardly ever" and "Never". The OHIP consists of 14 questions in which higher scores indicate worse outcomes.

Time frame
Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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