Caries,Dental, Head and Neck Cancer, Radiotherapy; Complications
Conditions
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 (i.e. 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.
Interventions
OTHERApplication of CaP dental mousse
Application of calcium phosphate (CaP) mousse on dental surfaces at home, once a day for 3 months; followed, as maintenance, once a day for just one week a month.
Sponsors
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* previous head and neck radiotherapy for oncological treatment
Exclusion criteria
* complete edentulism * pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of new cavitated caries per each patient (incidence of caries) | Assessment every 3 months up to 2 years | Identification of new carious lesion using International Caries Detection and Assessment System from score 0 initial lesions to 6 large cavitated lesions (ICDAS; 4-6) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with a diagnosis of osteoradionecrosis (incidence of osteoradionecrosis) | Assessment every 3 months up to 2 years | Number of new areas of bone necrosis |
| Number of dental surfaces with caries or filling, and missed teeth | Assessment every 3 months up to 2 years | Recording of the diseased, missed, filled surfaces (DMFS) index |
| Number of extracted teeth per patient (incidence of extracted teeth) | Assessment every 3 months up to 2 years | Number of new teeth extracted |
| Rate of dental surface with plaque per patient | Assessment every 3 months up to 2 years | Recording of full mouth plaque score (FMPS) (from 0 no plaque to 100% all dental surfaces with plaque) |
| Rate of bleeding gingival sites per patient | Assessment every 3 months up to 2 years | Recording of full mouth bleeding score (FMPS) (from 0 no plaque to 100% all gingival sites bleeding) |
| Rate of dentinal hypersensitivity per patient | Assessment every 12 months up to 2 years | Dentine Hypersensitivity Experience Questionnaire: the higher the score, the greater the impact of dentin sensitivity on daily life (items have coded responses on 7-point Likert scales: 1 = strongly disagree, 2 = disagree, 3 = agree a little, 4 = neither agree nor disagree, 5 = disagree a little, 6 = disagree and 7 = strongly disagree; a total score is then calculated) |
Countries
Italy
Outcome results
None listed