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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Caries, Pulpitis - Irreversible, Head and Neck Cancer

Intervention / Treatment
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* Procedure: Root canal treatment and crown


Participation Criteria
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Eligibility Criteria
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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: 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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This study involves a modified, expedited tooth restoration procedure for individuals scheduled to undergo radiation therapy for head and neck cancer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Root canal treatment and crown restoration | Procedure: Root canal treatment and crown<br>* Pre-radiation one day root canal treatment and CAD/CAM chair side fabricated crowns for head and neck cancer patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with successful completion of endodontic and restorative treatment of teeth (Feasibility) | 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. | 1-5 days | 
| Delay in RT initiation, calculated on a scale of 0-100 for the study, as described below (Feasibility) | Evaluation of whether the onset of radiation therapy was delayed due to participation in the EndoRest study. The evaluation will be on a per patient, not per tooth, basis. Delay in RT start will be scored on the following scale: 5 points: RT started as planned; no delays 4 points: RT delayed by 1 day due to participation in the EndoRest study 3 points: RT delayed by 2 days due to participation in the EndoRest study 2 points: RT delayed by 3 days due to participation in the EndoRest study 0 points: RT delated by 4 or more days due to participation in the EndoRest study The total points for all participants in the study will be summed. A score of >=90 indicated that the protocol is feasible. A total score <90 indicates that the protocol is not feasible. | 2-10 days | 
| Number of participants who need post-radiation extraction of a qualifying tooth. | Evaluation of whether a qualifying tooth for which endodontic and restorative treatment was successfully completed was extracted in the time interval post-radiation therapy up to 5 months after the initial visit. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of quality of life (QOL) based on the EORTC-QLQ-C30 | Quality of life and function will be assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) with the Head and Neck specific questionnaire add-on (HN43). This questionnaire assesses general quality of life as well as issues specific to head and neck cancer patients (e.g. difficulty swallowing, pain, dry mouth). All questions on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire EORTC-QLQ are assigned a score of 0-100. A higher score indicates a higher response level (for function questions, a high score indicates a high level of function, indicating a better outcome. For symptom questions, a high score indicates a high level of symptomology, indicating a worse outcome). | 5 months | 
| Evaluation of tooth survival | Tooth survival after completion of endodontic-restorative treatment will be assessed in all participants using standard survival analysis techniques. | 5 months | 
| Evaluation of endodontic status using the PAI | Endodontic status will be assessed using the periapical index (PAI). PAI uses a scale of 0-5, with 0 meaning healthy and 5 meaning severe periodontitis with exacerbated features. | 5 months | 
| Evaluation of periodontal status | Periodontal status will be assessed through probing depths of periodontal pockets of the treated tooth. | 5 months | 
| Evaluation of restorative status using the USPHS criteria | Restoration status will be assessed using United States Public Health System (USPHS) criteria. The USPHS criteria assesses anatomical form, marginal adaptation, color match, marginal discoloration, surface roughness, and caries, in a single assessment tool. Higher scores indicate less favorable outcomes. | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Restoration, Tooth Retention