Trial · NCT06055257
Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible
NCT06055257, Phase 3, Recruiting, Sunnybrook Health Sciences Centre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible. Trials, record NCT06055257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06055257
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible
- NCT number
- NCT06055257
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Conditions
- Osteoradionecrosis, Osteoradionecrosis of Jaw, Osteoradionecrosis of the Mandible
- Interventions
- modified PENTOCLO (mPENTOCLO), sham mPENTOCLO
- First posted
- 2023-09-26
- Last updated
- 2025-09-12
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06055257
GET https://conductscience.org/api/trials/v1/NCT06055257/registered