Clinical trial NCT04996641: Endodontic-Restorative Pre-Radiation Therapy of Head and Neck Cancer Patients
Official title: A Clinical Trial Pilot Study Investigating a New Dental Protocol for Pre-Radiation Endodontic-Restorative Therapy of Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulpitis - Irreversible
Caries
Head and Neck Cancer
Keywords: Restoration
Tooth Retention
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: University of Zagreb
First posted: 2021-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study involves a modified, expedited tooth restoration procedure for individuals scheduled to undergo radiation therapy for head and neck cancer.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with successful completion of endodontic and restorative treatment of teeth (Feasibility)
timeFrame: 1-5 days
measure: Delay in RT initiation, calculated on a scale of 0-100 for the study, as described below (Feasibility)
timeFrame: 2-10 days
measure: Number of participants who need post-radiation extraction of a qualifying tooth.
timeFrame: 5 months
Secondary outcomes:
measure: Evaluation of quality of life (QOL) based on the EORTC-QLQ-C30
timeFrame: 5 months
measure: Evaluation of tooth survival
timeFrame: 5 months
measure: Evaluation of endodontic status using the PAI
timeFrame: 5 months
measure: Evaluation of periodontal status
timeFrame: 5 months
measure: Evaluation of restorative status using the USPHS criteria
timeFrame: 5 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: School of Dental Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Frank Setzer, DMD, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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