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

NCT04996641 | Withdrawn

• 1 other identifier: UPCC 06321
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis - Irreversible; Caries; Head and Neck Cancer

Keywords

Restoration; Tooth Retention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Evaluation of quality of life (QOL) based on the EORTC-QLQ-C30

  5 months

• Evaluation of tooth survival

  5 months

• Evaluation of endodontic status using the PAI

  5 months

• Evaluation of periodontal status

  5 months

• Evaluation of restorative status using the USPHS criteria

  5 months

Study Arms (1)

Intervention

EXPERIMENTAL

Root canal treatment and crown restoration

Procedure: Root canal treatment and crown

Interventions

Root canal treatment and crown PROCEDURE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• University of Zagreb: collaborator

Study Sites (1)

School of Dental Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (8)

• 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.

  PMID: 22244627 BACKGROUND

• 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.

  PMID: 27071975 BACKGROUND

• 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.

  PMID: 16458773 BACKGROUND

• 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.

  PMID: 21115324 BACKGROUND

• 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.

  PMID: 17230555 BACKGROUND

• 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.

  PMID: 17321069 BACKGROUND

• 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.

  PMID: 9054917 BACKGROUND

• 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.

  PMID: 27068679 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Crowns

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• Frank Setzer, DMD, PhD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: August 9, 2021
• Study Start: January 3, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 27, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)