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

Head and Neck Cancer Clinical Trial

Official title:
A Clinical Trial Pilot Study Investigating a New Dental Protocol for Pre-Radiation Endodontic-Restorative Therapy of Head and Neck Cancer Patients

Clinical Trial 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.

Clinical Trial Description

Advanced radiation therapy systems are part of head/neck cancer treatment. 2-3 weeks prior to the initiation of radiation therapy (preRT), patients undergo dental screening, simple restorations and the removal of teeth deemed a osteoradionecrosis risk, often including asymptomatic, vital teeth. Time limitations preRT generally prohibit a traditional multi-visit approach for endodontic treatment, crown preparation, and an externally fabricated restoration. Precision restorative dentistry, with CAD/CAM milled ceramic restorations allow for immediate post-endodontic rehabilitation on the same. The Center for Clinical and Translational Research (CCTR) at PDM conducts the ARMOR trial, a randomized, controlled trial testing the efficacy of two oral care protocols enrolling 120 cancer patients from the Perelman Center for Advanced Medicine (PCAM) over 3.5 years. This pilot study will enroll 20 patients of the ARMOR trial for endodontic treatment and restoration of posterior asymptomatic and vital teeth using microscopic endodontics and digital precision CAD/CAM restoration. These teeth would otherwise be extracted due to time limitations preRT. Patients will be seen for the dental treatment within the time window from diagnosis to initiation of radiation therapy. Patients will be evaluated for (1) feasibility of the suggested protocol (primary objective); quality of life as in the ARMOR trial; 2) tooth survival; 3) endodontic status [PAI index]; 4) periodontal prognosis and status [McGuire-Nunn Criteria, etc]; and 5) restorative status [USPHS Criteria, etc] (secondary objectives) at 1,2,5 months follow-ups of the ARMOR trial. For control, data for tooth survival and QLQ will be compared to 20 other participants of the ARMOR trial (10/10 per study arm) that do not participate in the EndoRest substudy and to 20 other matching participants patients (age, gender) from an existing, comparable dataset of the ORA-RAD studies of the Penn Study arm at PDM Oral Medicine. Periodontal status and restorative status (iff applicable) will be compared to contra-lateral or counter-arch teeth of the individual participant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04996641
Study type Interventional
Source Abramson Cancer Center of the University of Pennsylvania
Contact
Status Withdrawn
Phase N/A
Start date January 3, 2022
Completion date September 30, 2022
View Details
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