Squamous Cell Carcinoma of Head and NeckOPPIDOMNCT04801472
Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)
A study testing Optimisation of dental implant sites protection from irradiation in people with Squamous Cell Carcinoma of Head and Neck and Oropharyngeal Squamous Cell Carcinoma, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
This is a monocentric, non-randomized, prospective, in silico feasibility study conducted by Strasbourg Europe Cancerology Institute. The purpose of this study is to evaluate the optimisation of potential dental implant sites protection, without degrading tumor volume coverage, through designation of potential dental… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma
- What is being tested?
- Optimisation of dental implant sites protection from irradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2021to 17 Jun 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥ 18 years old
- Performance Status 0 to 2
- Histologically-confirmed diagnosis of : infiltrating squamous cell carcinoma of the oral cavity or oropharynx
- Indication for an exclusive radiotherapy or post-surgery radiotherapy, with or without chemotherapy
- Indication for a radiotherapy of lymph node areas
- Partial or complete toothlessness requiring rehabilitation
- Signed informed consent from the patient
Who cannot join
- History of head and neck radiotherapy
- Partial mandibulectomy
- Retarded wound healing or trismus impairing radiological guide preparation
- Patient refusing the study
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
This is a monocentric, non-randomized, prospective, in silico feasibility study conducted by Strasbourg Europe Cancerology Institute. The purpose of this study is to evaluate the optimisation of potential dental implant sites protection, without degrading tumor volume coverage, through designation of potential dental implant sites before volume delineation and dosimetry calculations in patients with oropharyngeal or oral cavity squamous cell carcinoma treated by radiotherapy.
Read the detailed description
35 patients will be included in this study and will benefit from a dental consultation for dental rehabilitation plan elaboration and radiological guide confection. Two dosimetric computer-tomography scans, with or without radiological guide, will be conducted. Virtual dental implants will be visualised by the dental surgeon on scanner images (with or without radiologic guide). After volume delineation and dosimetry calculations, the optimal treatment plan will be validated. Patients will be followed throughout radiotherapy and during 18 months following the end of radiotherapy for evaluation of toxicity, quality of life and dental implant survival rate.
- Conditions
- Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma
- Being tested
- Optimisation of dental implant sites protection from irradiation
- Keywords
- Radiotherapy, Head and Neck cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimisation of dental implant sites protection from irradiationOther
Optimal treatment plan validation after two dosimetric computer-tomography scans (with or without radiological guide) and visualisation of virtual dental implants on scanner images.
Evaluation of toxicity, quality of life and dental implant survival rate
| Study group | Role | What they receive |
|---|---|---|
| Patients with oral cavity or oropharyngeal squamous cell carcinoma | Other | Not described Receives: Other: Optimisation of dental implant sites protection from irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected
Condition of dental implant sites protection (i.e. with minimal implantation risk, Dmax < 40 Gy), without degrading the coverage of planned targeted volume (≥ 95% of volume receiving 95 % of prescribed dose)
Measured: At baseline
Secondary outcomes (6)
Acute toxicity evaluation
according to CTCAE v5.0 criteria
Measured: every weeks during radiotherapy
Retarded toxicity evaluation
according to CTCAE v5.0 criteria
Measured: 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Quality of life assessed by the EORTC QLQ-C30 questionnaire
Score based on 30 items from EORTC QLQ-C30 questionnaire
Measured: At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Quality of life for patient with Head and Neck Cancer assessed by the EORTC QLQ-H&N35 supplementary questionnaire module
Score based on 35 items from EORTC QLQ-H\&N35 questionnaire
Measured: At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Oral health-related impact on patients quality of life assessed by the OHIP-14 questionnaire
Score based on 14 items from OHIP-14 questionnaire
Measured: At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Implant survival rate
Number of implant failure (Albrektsson modified criteria)
Measured: at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start7 May 2021
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Why it stopped: organisationnal reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpitaux Universitaires de Strasbourg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801472
- Sponsor's protocol ID
- 2020-013
- Acronym
- OPPIDOM
- Status last verified
- Dec 2025
- First submitted
- 11 Mar 2021
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)
- ClinicalTrials.gov ID
- NCT04801472
- Acronym / sponsor ID
- OPPIDOM / 2020-013
- Conditions
- Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma
- Keywords
- Radiotherapy, Head and Neck cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: organisationnal reason
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Collaborators
- Hôpitaux Universitaires de Strasbourg
- Study start
- 7 May 2021 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 17 Mar 2021 (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.
This is a monocentric, non-randomized, prospective, in silico feasibility study conducted by Strasbourg Europe Cancerology Institute. The purpose of this study is to evaluate the optimisation of potential dental implant sites protection, without degrading tumor volume coverage, through designation of potential dental implant sites before volume delineation and dosimetry calculations in patients with oropharyngeal or oral cavity squamous cell carcinoma treated by radiotherapy.
Detailed description
35 patients will be included in this study and will benefit from a dental consultation for dental rehabilitation plan elaboration and radiological guide confection. Two dosimetric computer-tomography scans, with or without radiological guide, will be conducted. Virtual dental implants will be visualised by the dental surgeon on scanner images (with or without radiologic guide). After volume delineation and dosimetry calculations, the optimal treatment plan will be validated. Patients will be followed throughout radiotherapy and during 18 months following the end of radiotherapy for evaluation of toxicity, quality of life and dental implant survival rate.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with oral cavity or oropharyngeal squamous cell carcinoma | Other | Other: Optimisation of dental implant sites protection from irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must be ≥ 18 years old
- Performance Status 0 to 2
- Histologically-confirmed diagnosis of : infiltrating squamous cell carcinoma of the oral cavity or oropharynx
- Indication for an exclusive radiotherapy or post-surgery radiotherapy, with or without chemotherapy
- Indication for a radiotherapy of lymph node areas
Key exclusion criteria (5 listed)
- History of head and neck radiotherapy
- Partial mandibulectomy
- Retarded wound healing or trismus impairing radiological guide preparation
- Patient refusing the study
- Pregnant women
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 |
|---|---|---|
| Optimisation of dental implant sites protection from irradiationOptimal treatment plan validation after two dosimetric computer-tomography scans (with or without radiological guide) and visualisation of virtual dental implants on scanner images. Evaluation of toxicity, quality of life and dental implant survival rate | Other | Patients with oral cavity or oropharyngeal squamous cell carcinoma |
Primary outcome
Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected
Time frame: At baseline
Condition of dental implant sites protection (i.e. with minimal implantation risk, Dmax < 40 Gy), without degrading the coverage of planned targeted volume (≥ 95% of volume receiving 95 % of prescribed dose)
6 secondary outcomes
Acute toxicity evaluation
Time frame: every weeks during radiotherapy
Retarded toxicity evaluation
Time frame: 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Quality of life assessed by the EORTC QLQ-C30 questionnaire
Time frame: At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Quality of life for patient with Head and Neck Cancer assessed by the EORTC QLQ-H&N35 supplementary questionnaire module
Time frame: At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Oral health-related impact on patients quality of life assessed by the OHIP-14 questionnaire
Time frame: At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Implant survival rate
Time frame: at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Results and safety
The study was stopped early (reason given: organisationnal reason). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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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?
A study testing Optimisation of dental implant sites protection from irradiation in people with Squamous Cell Carcinoma of Head and Neck and Oropharyngeal Squamous Cell Carcinoma, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Jan 2026. 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 France. 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?
The study was stopped early (reason given: organisationnal reason). 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?
Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026.