Head and Neck CancerNCT04009161
Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment.
An observational study of Head and Neck Cancer and Osteoradionecrosis, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer, Osteoradionecrosis, Radiotherapy Side Effect
- What is being tested?
- Tooth extraction
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 14 Mar 2017to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients irradiated for head and neck cancer
Who may be able to join
- Patients willing to sign the informed consent form
- Patients with diagnosis of HNC, with specific prescription of local radiotherapy, both for curative and palliative purpose, with or without chemotherapic treatment.
- Patient with diagnosis of HNC, with specific prescription of local radiotherapy as an adjuvant to surgical resection, with or without chemotherapic treatment.
Who cannot join
- Patients participating to other clinical studies
- Patients who refuse to participate in the study
- Patients unable to attend the ambulatory visits scheduled by the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment: a Perspective Clinical Study.
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).
- Being tested
- Tooth extraction
- Medical subject headings
- Head and Neck Neoplasms, Osteoradionecrosis, Radiation Injuries, Tooth Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extractionProcedure or surgery
Tooth extraction before the beginning of radiotherapy in patients irradiated for Head and Neck cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoradionecrosis Incidence
To evaluate the ORN incidence in a population irradiated for Head and Neck Cancer.
Measured: 60 months after the beginning of RT
Osteoradionecrosis rate following pre-radiotherapy tooth extraction
Measured: 60 months after the beginning of RT
Secondary outcomes (10)
Extraction site: number of tooth extractions for each site (anterior and posterior maxilla or mandible and specific tooth number) and percentage of ORN for each site.
Risk of ORN per extraction site
Measured: 60 months after the beginning of RT
Time interval between extraction and Radiotherapy: days between every tooth extraction and the beginning of RT.
To understand the relationship between this time-lapse and the ORN incidence
Measured: 60 months after the beginning of RT
Surgical protocol 1: Flap elevation per each extracted tooth (YES/NO) and percentage of ORN per each type of procedure.
Tooth extraction related risk factors
Measured: 60 months after the beginning of RT
Surgical protocol 2: Primary intention closure achievement per post-extractive site (YES/NO) and percentage of ORN per each type of procedure.
Tooth extraction related risk factors
Measured: 60 months after the beginning of RT
Surgical protocol 3: Osteotomy per each extracted tooth (YES/NO) and percentage of ORN per each type of procedure.
Tooth extraction related risk factors
Measured: 60 months after the beginning of RT
Reason for tooth extraction: number of tooth extraction for each cause under the protocol (caries, periodontal disease, endodontic lesions, pericoronitis, fracture) and percentage of ORN for each cause.
Tooth extraction related risk factors
Measured: 60 months after the beginning of RT
Radiation dose to the post-extractive site (Gy of radiation received by every post-extractive site)
Tooth extraction related risk factors
Measured: 60 months after the beginning of RT
Age of every patients at the beginning of RT
ORN risk factors
Measured: At baseline
Sex (male, female) of every patients at the beginning of RT
ORN risk factors
Measured: At baseline
Number of participants undergoing concurrent chemotherapy (neoadjuvant or concomitant)
ORN risk factors
Measured: During treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start14 Mar 2017
- Primary completion1 Jun 2023
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Lajolo, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009161
- Sponsor's protocol ID
- ORN-HN-1
- Status last verified
- Aug 2023
- First submitted
- 19 Jun 2019
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rupe C, Gioco G, Corraro B, Schiavelli A, Longo S, Pastore F, Massaccesi M, Gambacorta MA, Micciche F, Castagnola R, Galli J, Settimi S, Raffaelli L, Cassano A, Cordaro M, Lajolo C. Worsening of Oral Health Parameters After Head and Neck Radiotherapy-Findings from a Multidisciplinary Head and Neck Tumor Board: A Prospective Observational Study. Cancers (Basel). 2026 Oct 5;18(19):3211. doi: 10.3390/cancers18193211.
PubMed 42882905Rupe C, Gioco G, Tranfa M, Scilla F, Schiavelli A, Cairo F, Galli J, Scambia G, Rengo C, Lajolo C. Differences in oral health status between cancer patients: a case-control observational study. BMC Oral Health. 2025 Dec 1;25(1):1862. doi: 10.1186/s12903-025-06963-7.
PubMed 41327109Rupe C, Gioco G, Massaccesi M, Tagliaferri L, Pastore F, Micciche F, Galli J, Mele D, Specchia ML, Cassano A, Cordaro M, Lajolo C. Osteoradionecrosis incidence in pre-radiation teeth extractions: A prospective study. Oral Dis. 2024 Nov;30(8):5129-5139. doi: 10.1111/odi.14941. Epub 2024 Apr 9.
PubMed 38591808Rupe C, Gioco G, Almadori G, Galli J, Micciche F, Olivieri M, Cordaro M, Lajolo C. Oral Candida 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. Cancers (Basel). 2022 Sep 29;14(19):4746. doi: 10.3390/cancers14194746.
PubMed 36230669
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment: a Perspective Clinical Study.
- ClinicalTrials.gov ID
- NCT04009161
- Acronym / sponsor ID
- ORN-HN-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients irradiated for head and neck cancer
Key inclusion criteria (3 listed)
- Patients willing to sign the informed consent form
- Patients with diagnosis of HNC, with specific prescription of local radiotherapy, both for curative and palliative purpose, with or without chemotherapic treatment.
- Patient with diagnosis of HNC, with specific prescription of local radiotherapy as an adjuvant to surgical resection, with or without chemotherapic treatment.
Key exclusion criteria (3 listed)
- Patients participating to other clinical studies
- Patients who refuse to participate in the study
- Patients unable to attend the ambulatory visits scheduled by the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth extractionTooth extraction before the beginning of radiotherapy in patients irradiated for Head and Neck cancer | Procedure or surgery | – |
Primary outcome
Osteoradionecrosis Incidence
Time frame: 60 months after the beginning of RT
To evaluate the ORN incidence in a population irradiated for Head and Neck Cancer.
Osteoradionecrosis rate following pre-radiotherapy tooth extraction
Time frame: 60 months after the beginning of RT
10 secondary outcomes
Extraction site: number of tooth extractions for each site (anterior and posterior maxilla or mandible and specific tooth number) and percentage of ORN for each site.
Time frame: 60 months after the beginning of RT
Time interval between extraction and Radiotherapy: days between every tooth extraction and the beginning of RT.
Time frame: 60 months after the beginning of RT
Surgical protocol 1: Flap elevation per each extracted tooth (YES/NO) and percentage of ORN per each type of procedure.
Time frame: 60 months after the beginning of RT
Surgical protocol 2: Primary intention closure achievement per post-extractive site (YES/NO) and percentage of ORN per each type of procedure.
Time frame: 60 months after the beginning of RT
Surgical protocol 3: Osteotomy per each extracted tooth (YES/NO) and percentage of ORN per each type of procedure.
Time frame: 60 months after the beginning of RT
Reason for tooth extraction: number of tooth extraction for each cause under the protocol (caries, periodontal disease, endodontic lesions, pericoronitis, fracture) and percentage of ORN for each cause.
Time frame: 60 months after the beginning of RT
Radiation dose to the post-extractive site (Gy of radiation received by every post-extractive site)
Time frame: 60 months after the beginning of RT
Age of every patients at the beginning of RT
Time frame: At baseline
Sex (male, female) of every patients at the beginning of RT
Time frame: At baseline
Number of participants undergoing concurrent chemotherapy (neoadjuvant or concomitant)
Time frame: During treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Derived from this study: PubMed 42882905Rupe C, Gioco G, Corraro B, Schiavelli A, Longo S, Pastore F, Massaccesi M, Gambacorta MA, Micciche F, Castagnola R, Galli J, Settimi S, Raffaelli L, Cassano A, Cordaro M, Lajolo C. Worsening of Oral Health Parameters After Head and Neck Radiotherapy-Findings from a Multidisciplinary Head and Neck Tumor Board: A Prospective Observational Study. Cancers (Basel). 2026 Oct 5;18(19):3211. doi: 10.3390/cancers18193211.
- Derived from this study: PubMed 41327109Rupe C, Gioco G, Tranfa M, Scilla F, Schiavelli A, Cairo F, Galli J, Scambia G, Rengo C, Lajolo C. Differences in oral health status between cancer patients: a case-control observational study. BMC Oral Health. 2025 Dec 1;25(1):1862. doi: 10.1186/s12903-025-06963-7.
- Derived from this study: PubMed 38591808Rupe C, Gioco G, Massaccesi M, Tagliaferri L, Pastore F, Micciche F, Galli J, Mele D, Specchia ML, Cassano A, Cordaro M, Lajolo C. Osteoradionecrosis incidence in pre-radiation teeth extractions: A prospective study. Oral Dis. 2024 Nov;30(8):5129-5139. doi: 10.1111/odi.14941. Epub 2024 Apr 9.
- Derived from this study: PubMed 36230669Rupe C, Gioco G, Almadori G, Galli J, Micciche F, Olivieri M, Cordaro M, Lajolo C. Oral Candida 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. Cancers (Basel). 2022 Sep 29;14(19):4746. doi: 10.3390/cancers14194746.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Osteoradionecrosis, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteoradionecrosis Incidence (time frame: 60 months after the beginning of RT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04009161, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.