WithdrawnNot Applicable

Endodontic-Restorative Pre-Radiation Therapy of Head and Neck Cancer Patients

Stopped: Unable to enroll participants

United States0Started 2022-01-03

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient volunteering to participate in the study.
✓. Patients eligible for participation in the ARMOR trial (current head and neck cancer patient trial conducted at Penn Dental Medicine\[PDM\])
✓. Non-contributory medical history (Patient can be seen for dental appointment in PDM).
✓. No history of previous endodontic treatment on the tooth/teeth selected for treatment.
✓. Asymptomatic and vital teeth with deep decay (Irreversible pulpitis due to decay reaching pulp).

Exclusion criteria

✕. Symptoms or necrotic tooth with presence of periapical radioluceny.
✕. History of previous endodontic treatment on the teeth to be treated.
✕. Teeth affected by fractures.
✕. Compromised periodontal status with pockets exceeding 4 mm, exceeding mobility I or gingival edema).
✕. At the discretion of the PI, patient is unlikely or unwilling to follow study requirements.

What they're measuring

Number of participants with successful completion of endodontic and restorative treatment of teeth (Feasibility)

Timeframe: 1-5 days

Delay in RT initiation, calculated on a scale of 0-100 for the study, as described below (Feasibility)

Timeframe: 2-10 days

Number of participants who need post-radiation extraction of a qualifying tooth.

Timeframe: 5 months

Trial details

NCT IDNCT04996641

SponsorAbramson Cancer Center at Penn Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Pulpitis - Irreversible trials