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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2022-09-30

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.

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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.

Conditions

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Pulpitis - Irreversible Caries Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study involves a modified, expedited tooth restoration procedure for individuals scheduled to undergo radiation therapy for head and neck cancer.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Root canal treatment and crown restoration

Group Type EXPERIMENTAL

Root canal treatment and crown

Intervention Type PROCEDURE

Pre-radiation one day root canal treatment and CAD/CAM chair side fabricated crowns for head and neck cancer patients

Interventions

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Root canal treatment and crown

Pre-radiation one day root canal treatment and CAD/CAM chair side fabricated crowns for head and neck cancer patients

Intervention Type PROCEDURE

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No