NCT04009161 is a clinical trial of Tooth extraction in Head and Neck Cancer, sponsored by Catholic University of the Sacred Heart.

Who is sponsoring NCT04009161?

NCT04009161 is sponsored by Catholic University of the Sacred Heart.

What drugs are being tested in NCT04009161?

Interventions in NCT04009161: Tooth extraction.

What condition does NCT04009161 study?

NCT04009161 studies Head and Neck Cancer, Osteoradionecrosis, Radiotherapy Side Effect, Tooth Avulsion.

Is NCT04009161 still recruiting?

NCT04009161 is currently status unknown. Last updated 30 August 2023.

Last reviewed 2023-08-30 · How we verify

NCT04009161

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment.

Status unknown Last updated 30 August 2023

What this trial tests

trial testing Tooth extraction in Head and Neck Cancer in 160 participants. Status unknown.

Timeline

14 March 2017

Primary endpoint
1 June 2023

1 June 2025

Quick facts

Lead sponsor	Catholic University of the Sacred Heart
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	160
Start date	14 March 2017
Primary completion	1 June 2023
Estimated completion	1 June 2025
Sites	1 location across Italy

Drugs / interventions tested

Tooth extraction

Conditions studied

Head and Neck Cancer — all drugs for Head and Neck Cancer →
Osteoradionecrosis — all drugs for Osteoradionecrosis →
Radiotherapy Side Effect — all drugs for Radiotherapy Side Effect →
Tooth Avulsion — all drugs for Tooth Avulsion →

Sponsor

Catholic University of the Sacred Heart

Who can join

Eligibility, any sex, with Head and Neck Cancer or Osteoradionecrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objectives High-dose radiotherapy (RT) for head and neck cancer has significant adverse effects on maxillofacial tissues, among which osteoradionecrosis (ORN) is the most severe and potentially life-threatening. Although tooth extractions seem to be the main risk factor, few perspective studies evaluated protocols to minimize the ORN risk due to extractions. The aim of this study is to evaluate incidence and risk factors of ORN in a cohort of patients receiving tooth extractions before RT and evaluate an algorithm about extraction decision. Methods One-hundred ten patients were consecutively recruited in this study: impacted third molars with radiographic sign of pericoronitis, teeth with periapical lesions, unrestorable teeth, periodontally compromised teeth (pocket probing depth \>5 mm, clinical attachment loss \> 8 mm, grade 2 tooth mobility, II grade furcation involvement) were extracted under antibiotic prophylaxis. A 15-days interval between the last tooth extraction and the beginning of RT was recommended. Patients were visited at 15 days, 1, 3 and 6 months after the beginning of RT. Data of patients with a minimum of 6 months follow-up are presented in this report. ORN was defined as irradiated exposed necrotic bone, without healing for 3 months, in absence of cancer recurrence. The protocol was approved by the Ethic Committee of Catholic University - Fondazione Policlinico Gemelli (Prot. OHHN-1, ID-2132).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Oral Health Status in Patients with Head and Neck Cancer before Radiotherapy: Baseline Description of an Observational Prospective Study.
Rupe C, Basco A, Schiavelli A, Cassano A, et al · · 2022 · cited 18× · PMID 35326564 · DOI 10.3390/cancers14061411
Oral <i>Candida</i> spp. Colonisation Is a Risk Factor for Severe Oral Mucositis in Patients Undergoing Radiotherapy for Head & Neck Cancer: Results from a Multidisciplinary Mono-Institutional Prospective Observational Study.
Rupe C, Gioco G, Almadori G, Galli J, et al · · 2022 · cited 17× · PMID 36230669 · DOI 10.3390/cancers14194746
Osteoradionecrosis incidence in pre-radiation teeth extractions: A prospective study.
Rupe C, Gioco G, Massaccesi M, Tagliaferri L, et al · · 2024 · cited 10× · PMID 38591808 · DOI 10.1111/odi.14941
Clinical outcomes of teeth adjacent to the site of mandibulotomy or mandibulectomy in patients with head and neck cancer: results from a multidisciplinary mono-institutional head and neck tumor board.
Castagnola R, Rupe C, Gioco G, Almadori G, et al · · 2023 · cited 5× · PMID 37270480 · DOI 10.1186/s12903-023-03050-7
Differences in oral health status between cancer patients: a case-control observational study.
Rupe C, Gioco G, Tranfa M, Scilla F, et al · · 2025 · PMID 41327109 · DOI 10.1186/s12903-025-06963-7
Letter to the editor referencing "Body composition changes in patients with head and neck cancer under active treatment: a scoping review".
Cacicedo J, Mendizabal N, Arietaleanizbeaskoa MS. · · 2022 · PMID 33742245 · DOI 10.1007/s00520-021-05999-z

Verify or expand the search:

Other trials of Tooth extraction

Trials testing the same drug.

NCT06520137 — Third Molars Extraction and Periodontal Disease · recruiting
NCT05595772 — Comparison of Two Different Types of Platelet Concentrate to Augment Bone Around Immediate Dental Implant · NA · unknown
NCT06496906 — Clinical and Radiographic Comparison of Two Minimally Invasive Tooth Extraction Systems · NA · completed
NCT04763187 — Post-extractive Alveolus Regeneration · NA · completed
NCT05662709 — Leukocyte and Platelet-rich Fibrin (L-PRF) Effects on Alveolar Ridge Preservation. A Randomized Controlled Clinical Tria · Phase 3 · unknown

Other recruiting trials for Head and Neck Cancer

Currently open trials in the same condition.

NCT07318220 — Prehabilitation Protocol for Head and Neck Cancer Patients · NA · recruiting
NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
NCT07467083 — Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Unde · Phase 3 · recruiting
NCT07209189 — Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-esca · Phase 2 · recruiting
NCT06837480 — Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema · NA · recruiting

Other Catholic University of the Sacred Heart trials

Trials by the same sponsor.

NCT07476599 — The OB-WELL Project, a Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Ob · NA · not yet recruiting
NCT07516392 — Study of a Polygenic Risk Score to Predict the Risk of Pancreatic Ductal Adenocarcinoma · NA · not yet recruiting
NCT07140705 — Personalized Virtual Reality for Promoting Well-Being and Psychological Flexibility in General Practitioners · NA · completed
NCT06992453 — Multi-omics Dissection of Gut Microbiome Engraftment During FMT · NA · not yet recruiting
NCT06852183 — Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04009161 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Catholic University of the Sacred Heart
Last refreshed: 30 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04009161.

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