Trial · NCT06055257
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment and adherence to protocol (process) | Pilot study (including 12-month follow-up) | Recruitment of two subjects per month on average over 12 months |
| Primary | Recruitment and adherence to protocol (process) | Pilot study (including 12-month follow-up) | At least 70% of all eligible patients are recruited |
| Primary | Recruitment and adherence to protocol (process) | Pilot study (including 12-month follow-up) | More than 80% of all recruited subjects complete 60 sessions of HBOT (20/24) |
| Primary | Recruitment and adherence to protocol (process) | Pilot study (including 12-month follow-up) | More than 80% of patients in mPENTOCLO group complete mPENTOCLO protocol (10/12) |
| Primary | Recruitment and adherence to protocol (process) | Pilot study (including 12-month follow-up) | 80% 12-month follow-up rate (20/24) |
| Primary | Feasibility (resource) - Time | Pilot study (including 12-month follow-up) | Investigators to keep logs of time required to perform study related work |
| Primary | Feasibility (resource) - Cost | Pilot study (including 12-month follow-up) | Cost of study including research support and healthcare resource costs per patient |
| Secondary | Recovery from ORN at one-year follow-up | 12-month follow-up | Proportion of patients reaching recovery within the study period in each group. "Recovery" will be defined as the absence of pain, pathologic fracture, and cutaneous fistula; exposed bone area (EBA) less than 20 mm2; and by evidence of stabilization or regression on radiographic findings (Notani classification score). Minor bone spicules of less than 20 mm2 that have no ongoing pain, and no radiographic abnormalities will be considered fully healed and not Notani grade 1. |
| Secondary | Time required to achieve recovery in patients | Assessed at each scheduled follow-up (4 weeks, 5/6 weeks, and 3, 6, 9 and 12 months) | Difference in time required to reach recovery in each group. "Recovery" will be defined as the absence of pain, pathologic fracture, and cutaneous fistula; exposed bone area (EBA) less than 20 mm2; and by evidence of stabilization or regression on radiographic findings (Notani classification score). Minor bone spicules of less than 20 mm2 that have no ongoing pain, and no radiographic abnormalities will be considered fully healed and not Notani grade 1. |
| Secondary | Improvement and failure rates in patients treated in each group using an accepted clinical and radiographic scoring system: | Assessed at each scheduled follow-up (4 weeks, 5/6 weeks, and 3, 6, 9 and 12 months) | Exposed bone area (EBA) |
| Secondary | Improvement and failure rates in patients treated in each group using an accepted clinical and radiographic scoring system: | Assessed at each scheduled follow-up (4 weeks, 5/6 weeks, and 3, 6, 9 and 12 months) | Notani Classification Score I ORN confined to dentoalveolar bone II ORN limited to dentoalveolar bone or mandible above the inferior dental canal, or both III ORN involving the mandible below the inferior dental canal, or pathological fracture, or skin fistula |
| Secondary | Improvement and failure rates in patients treated in each group using an accepted clinical and radiographic scoring system: | Assessed at each scheduled follow-up (4 weeks, 5/6 weeks, and 3, 6, 9 and 12 months) | Late Effects Normal Tissue Task Force-Subjective, Objective, Management and Analytic (LENT-SOMA) score |
| Secondary | Complications that arise from treatment | Assessed at each scheduled follow-up (4 weeks, 5/6 weeks, and 3, 6, 9 and 12 months) | Complications related to HBOT and/or mPENTOCLO, as defined in product monographs and study protocol. |
| Other | Quality of Life questionnaire | Assessed at each scheduled follow-up (4 weeks, 5/6 weeks, and 3, 6, 9 and 12 months) | Assessed using EQ-5D-5L questionnaire |
| Other | Xerostomia severity | Assessed at each scheduled follow-up (4 weeks, 5/6 weeks, and 3, 6, 9 and 12 months) | Assessed using Xerostomia Inventory and/or Clinical Oral Dryness Score |
| Other | Opioid usage | Assessed at each scheduled follow-up (4 weeks, 5/6 weeks, and 3, 6, 9 and 12 months) | Medications and dosages (oral morphine equivalents) currently being taken by participants at each scheduled follow-up |
| Other | ORN Pain | Assessed at each scheduled follow-up (4 weeks, 5/6 weeks, and 3, 6, 9 and 12 months) | Assessed using Numerical Rating Scale (NRS) patient to rate their pain on scale of 0-10 where 0 is no pain and 10 is the worst pain imaginable |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06055257/registered