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NCT04452032: StomRay
Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer
Phase 2 trial testing Dental avulsion in Head and Neck Squamous Cell Carcinoma in 40 participants. Participants enrolled and being followed up; not accepting new ones.
16 May 2026
Quick facts
| Lead sponsor | Jules Bordet Institute |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 40 |
| Start date | 17 November 2020 |
| Primary completion | 16 May 2026 |
| Estimated completion | 16 May 2027 |
| Sites | 3 locations across Belgium |
Drugs / interventions tested
- Dental avulsion
- Radiotherapy — full drug profile →
Conditions studied
- Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
Sponsor
Jules Bordet Institute
Who can join
18 and older, any sex, with Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Multi-centric, one arm phase II study. The first phase of the study will consist of an evaluation of the initial dental state of each subject based on a stomatological examination, an orthopantomogram, two bitewing radiographs (right and left sides) and an evaluation of all potential risks of caries and fractures. For all of subjects, a dental decalcification, dental care and/or avulsion if necessary, and afterwards, a dental splint will be performed before the start of RT treatment. Our previously developed predictive model for dental dose in function of the localisation of tumour and suspect lymph nodes based on the stomatological examination and on the pre-treatment imaging. An estimation of the intensity-modulated radiotherapy (IMRT) teeth dose will be made and translated into a colour based form of the pre-RT dental status. A contouring of the teeth will be performed and the planned dose for each tooth of each subject will be recorded by a dose volume histogram (DVH) curve based on the pre-treatment imaging. In the same way the mean dose and the V25 (the volume receiving 25 Gy) of the homo- and the heterolateral parotid gland will be calculated. Based on our predictive model, every tooth which potentially will receive more than 40 Gy and for which long term survival is compromised will be avulsed at least 2 weeks before the start of RT. After RT, the subject will have clinical follow-up with dental evaluation every 6 months for 36 months in order to identify possible dental events. At each consultation, a stomatological examination will be performed as well as two bitewing radiographs. An orthopantomogram will be done once a year. Furthermore, periapical X-rays will be performed if there is a dental complain or to refine a lesion visible on orthopantomogram.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Prospective pilot study evaluating dental side effects of radiotherapy on subjects treated for head and neck cancer: StomRay Study
Karaca Y, Beauvois S, wardi CA, Keddar M, et al · · 2024 · DOI 10.21203/rs.3.rs-4642483/v1
Verify or expand the search:
- PubMed search for NCT04452032
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jules Bordet Institute trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04452032 (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 Jules Bordet Institute
- Last refreshed: 8 November 2024
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/NCT04452032.
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