The Characterisation of RT Caries.
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|ClinicalTrials.gov Identifier: NCT03397823|
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : March 1, 2019
Head and neck cancer represent 4-5% of all of cancer diagnosed in the UK, the first choice of treatment it is Radiotherapy (RT). RT is known to produce a wide range of oral side effects such as hypo-salivation, caries, xerostomia, mucositis and osteoradionecrosis.
Hypo-salivation may lead to a shift in diversity of the bacterial population altering oral homeostasis. RT may also cause a variation in saliva protein composition which can affect its rheological properties and host defence increasing the possibility of caries development. Additionally, the effects of RT on the organic and inorganic structure/ composition of teeth and the possible relation with caries risk have not been investigated so far.
Mucositis is another frequent oral complication of RT and it is estimated that more than 80% of the treated patients will develop this condition.
Longitudinal studies assessing all these conditions before and after cancer treatment have not been reported in literature to date.
Therefore, the main objective of the proposed study is to assess the chemical composition of the dentine matrix, the variations in salivary proteins and in oral microbiome occurring in Head & Neck cancer patients undergoing RT. These data will be collected and a complete oral assessment with 18 month follow up will be performed. All these data will be computed to demonstrate the associations between RT and caries risk to demonstrate possible mechanistic causes.
|Condition or disease|
|Head and Neck Cancer Radiotherapy Side Effect|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||102 participants|
|Official Title:||The Characterisation of Therapeutic Radiation-induced Caries; the Histopathological, Ultrastructural and Microbial Changes Affecting Its Prevention and Treatment.|
|Actual Study Start Date :||February 15, 2017|
|Estimated Primary Completion Date :||October 30, 2019|
|Estimated Study Completion Date :||October 30, 2019|
head and neck cancer pre RT
head and neck cancer patients before and after RT
head and neck cancer treated
head and neck cancer patients treated with radiotherapy
subjects matched in gender and age without cancer
- radiotherapy effects on oral microbiota [ Time Frame: until October 2019 ]To perform high throughput sequencing techniques on saliva, caries and oral swab samples to detect bacterial species prevalence. DNA extraction will be performed in order to characterise the microbial diversity of the oral biofilm, whole mouth saliva, and caries of head and neck cancer patients before and after radiotherapy and compare with healthy control subjects using Illumina sequencing platform.
- radiotherapy effects on salivary proteins [ Time Frame: 2019 ]In order to determinate the shift in saliva protein composition it will be analysed; total protein content and specific proteins concentration. Total protein concentration in saliva obtained from all subjects will be determinate using BCA assay, then using enzyme linked immunosorbent assay (ELISA) to quantify the presence of targeted proteins.
- radiotherapy effects on dentine matrix [ Time Frame: 2019 ]To image dentine samples by two-photon microscopy and quantify possible variations in collagen content by image J analysis programme.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397823
|Contact: maria firstname.lastname@example.org|
|kings college london, Guy's Hospital||Recruiting|
|London, United Kingdom, SE1 9RT|
|Contact: maria gonzalez 7470223082 email@example.com|
|Principal Investigator: avijit banerjee, professor|
|Principal Investigator:||avijit banerjee, professor||King's College London|