Clinical trial · Interventional
Endodontic-Restorative Pre-Radiation Therapy of Head and Neck Cancer Patients
A Clinical Trial Pilot Study Investigating a New Dental Protocol for Pre-Radiation Endodontic-Restorative Therapy of Head and Neck Cancer Patients
NCT04996641CI-TRIAL-00064259EndoRestwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to enroll participants
Summary
Brief summary (as posted)
Pilot study involving 20 patients undergoing dental treatment prior to radiation therapy. Comparison of outcome parameters to existing data of age and gender matched patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Caries | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Pulpitis - Irreversible | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Root canal treatment and crown | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Root canal treatment and crown restoration
- interventionNames
- Procedure: Root canal treatment and crown
Primary outcomes (3)
- measure
- Number of participants with successful completion of endodontic and restorative treatment of teeth (Feasibility)
- timeFrame
- 1-5 days
- description
- Evaluation of whether the proposed one-day root canal treatment plus crown restoration protocol can be utilized and executed prior to radiation treatment of head and neck cancer patients. The evaluation will be on a per patient, not per tooth, basis. Failure is defined as the inability to complete endodontic treatment and definitive restoration of a qualifying tooth in a study participant, resulting in the need for pre-radiation extraction of the tooth.
- measure
- Delay in RT initiation, calculated on a scale of 0-100 for the study, as described below (Feasibility)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient volunteering to participate in the study. 2. Patients eligible for participation in the ARMOR trial (current head and neck cancer patient trial conducted at Penn Dental Medicine\[PDM\]) 3. Non-contributory medical history (Patient can be seen for dental appointment in PDM). 4. No history of previous endodontic treatment on the tooth/teeth selected for treatment. 5. Asymptomatic and vital teeth with deep decay (Irreversible pulpitis due to decay reaching pulp). Exclusion Criteria: Economic status, gender, race or ethnicity are not of concern for the proposed investigation and therefore for study exclusion. Patients will not be eligible to participate in the study if any of the following exclusion criteria applies: 1. Symptoms or necrotic tooth with presence of periapical radioluceny. 2. History of previous endodontic treatment on the teeth to be treated. 3. Teeth affected by fractures. 4. Compromised periodontal status with pockets exceeding 4 mm, exceeding mobility I or gingival edema). 5. At the discretion of the PI, patient is unlikely or unwilling to follow study requirements.
References
Publications (8)
- BACKGROUNDKataoka SH, Setzer FC, Fregnani ER, Pessoa OF, Gondim E Jr, Caldeira CL. Effects of 3-dimensional conformal or intensity-modulated radiotherapy on dental pulp sensitivity during and after the treatment of oral or oropharyngeal malignancies. J Endod. 2012 Feb;38(2):148-52. doi: 10.1016/j.joen.2011.09.022. Epub 2011 Nov 14. PMID 22244627
- BACKGROUNDKataoka SH, Setzer FC, Gondim-Junior E, Fregnani ER, Moraes CJ, Pessoa OF, Gavini G, Caldeira CL. Late Effects of Head and Neck Radiotherapy on Pulp Vitality Assessed by Pulse Oximetry. J Endod. 2016 Jun;42(6):886-9. doi: 10.1016/j.joen.2016.02.016. Epub 2016 Apr 9. PMID 27071975
- BACKGROUNDWahl MJ. Osteoradionecrosis prevention myths. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):661-9. doi: 10.1016/j.ijrobp.2005.10.021. PMID 16458773
- BACKGROUNDNabil S, Samman N. Incidence and prevention of osteoradionecrosis after dental extraction in irradiated patients: a systematic review. Int J Oral Maxillofac Surg. 2011 Mar;40(3):229-43. doi: 10.1016/j.ijom.2010.10.005. Epub 2010 Nov 5. PMID 21115324
- BACKGROUNDChang DT, Sandow PR, Morris CG, Hollander R, Scarborough L, Amdur RJ, Mendenhall WM. Do pre-irradiation dental extractions reduce the risk of osteoradionecrosis of the mandible? Head Neck. 2007 Jun;29(6):528-36. doi: 10.1002/hed.20538. PMID 17230555
- BACKGROUNDBen-David MA, Diamante M, Radawski JD, Vineberg KA, Stroup C, Murdoch-Kinch CA, Zwetchkenbaum SR, Eisbruch A. Lack of osteoradionecrosis of the mandible after intensity-modulated radiotherapy for head and neck cancer: likely contributions of both dental care and improved dose distributions. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):396-402. doi: 10.1016/j.ijrobp.2006.11.059. Epub 2007 Feb 22. PMID 17321069
- BACKGROUNDClayman L. Clinical controversies in oral and maxillofacial surgery: Part two. Management of dental extractions in irradiated jaws: a protocol without hyperbaric oxygen therapy. J Oral Maxillofac Surg. 1997 Mar;55(3):275-81. doi: 10.1016/s0278-2391(97)90542-5. No abstract available.