Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308796
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-02
Brief Title:
Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy
Sponsor:
University of Milan
Organization:
University of Milan
Study Overview
Official Title:
Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADIOCARIES
Brief Summary:
One of the long-term side effects of head and neck radiotherapy RT is radiation-induced tooth decay Hyposalivation associated with radiation therapy further increases caries susceptibility and caries progression due to the lack of salivary protective effects and of tooth minerals useful for remineralization processes especially calcium phosphate CaP Dental extractions that could be required in case of severe tooth decay expose the patient to the risk of osteoradionecrosis of the jaws ie the necrosis of the bone tissue following a local trauma including surgical trauma This protocol aims at verifying the effectiveness of CaP mousse in the prevention of carious lesions added to topical fluoride A randomized controlled clinical trial will be performed comparing CaP fluoride treatment versus no treatment in head and neck cancer patients who received radiotherapy The hypothesis is that CaP which is lacking in the mouth of these patients due to hyposalivation can combine with fluoride to promote remineralization reducing the risk of carious lesions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None