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

Head and Neck Cancer Clinical Trial

— EndoRest  

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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04996641
• Other study ID #: UPCC 06321
• Status: Withdrawn
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2022
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caries
• Head and Neck Cancer
• Head and Neck Neoplasms
• Pulpitis
• Pulpitis - Irreversible

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	School of Dental Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	School of Dental Medicine

Country where clinical trial is conducted

United States, 

References & Publications (8)

Ben-David MA, Diamante M, Radawski JD, Vineberg KA, Stroup C, Murdoch-Kinch CA, Zwetchkenbaum SR, Eisbruch A. Lack of osteoradionecrosis of the mandible after intensity-modulated radiotherapy for head and neck cancer: likely contributions of both dental care and improved dose distributions. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):396-402. doi: 10.1016/j.ijrobp.2006.11.059. Epub 2007 Feb 22. — View Citation

Chang DT, Sandow PR, Morris CG, Hollander R, Scarborough L, Amdur RJ, Mendenhall WM. Do pre-irradiation dental extractions reduce the risk of osteoradionecrosis of the mandible? Head Neck. 2007 Jun;29(6):528-36. doi: 10.1002/hed.20538. — View Citation

Clayman L. Clinical controversies in oral and maxillofacial surgery: Part two. Management of dental extractions in irradiated jaws: a protocol without hyperbaric oxygen therapy. J Oral Maxillofac Surg. 1997 Mar;55(3):275-81. doi: 10.1016/s0278-2391(97)90542-5. No abstract available. — View Citation

Hentz C, Diaz AZ, Borrowdale RW, Emami B, Kase M, Choi M. Establishing a targeted plan for prophylactic dental extractions in patients with laryngeal cancer receiving adjuvant radiotherapy. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Jul;122(1):43-9. doi: 10.1016/j.oooo.2016.01.021. Epub 2016 Feb 13. — View Citation

Kataoka SH, Setzer FC, Fregnani ER, Pessoa OF, Gondim E Jr, Caldeira CL. Effects of 3-dimensional conformal or intensity-modulated radiotherapy on dental pulp sensitivity during and after the treatment of oral or oropharyngeal malignancies. J Endod. 2012 Feb;38(2):148-52. doi: 10.1016/j.joen.2011.09.022. Epub 2011 Nov 14. — View Citation

Kataoka SH, Setzer FC, Gondim-Junior E, Fregnani ER, Moraes CJ, Pessoa OF, Gavini G, Caldeira CL. Late Effects of Head and Neck Radiotherapy on Pulp Vitality Assessed by Pulse Oximetry. J Endod. 2016 Jun;42(6):886-9. doi: 10.1016/j.joen.2016.02.016. Epub 2016 Apr 9. — View Citation

Nabil S, Samman N. Incidence and prevention of osteoradionecrosis after dental extraction in irradiated patients: a systematic review. Int J Oral Maxillofac Surg. 2011 Mar;40(3):229-43. doi: 10.1016/j.ijom.2010.10.005. Epub 2010 Nov 5. — View Citation

Wahl MJ. Osteoradionecrosis prevention myths. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):661-9. doi: 10.1016/j.ijrobp.2005.10.021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Evaluation of periodontal status	Periodontal status will be assessed through probing depths of periodontal pockets of the treated tooth.	5 months
Secondary	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