| CTRI Number |
CTRI/2019/03/017977 [Registered on: 07/03/2019] Trial Registered Prospectively |
| Last Modified On: |
05/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To test saliva and compare anti-caries agents for prevention of radiation caries among Head and Neck cancer patients undergoing radiotherapy. |
|
Scientific Title of Study
|
Evaluation of saliva and comparison of anti-caries agents for prevention of radiation caries among Head and Neck cancer patients undergoing radiotherapy - an invivo study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UPASANA |
| Designation |
lecturer |
| Affiliation |
A.B.Shetty Institute of Dental Sciences |
| Address |
A B Shetty Memorial Institute of Dental Sciences,
Derlakatte, Mangaluru, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845827259 |
| Fax |
|
| Email |
upasana.reddy.88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
UPASANA |
| Designation |
lecturer |
| Affiliation |
A.B.Shetty Institute of Dental Sciences |
| Address |
A B Shetty Memorial Institute of Dental Sciences,
Derlakatte, Mangaluru, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845827259 |
| Fax |
|
| Email |
upasana.reddy.88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
UPASANA |
| Designation |
lecturer |
| Affiliation |
A.B.Shetty Institute of Dental Sciences |
| Address |
A B Shetty Memorial Institute of Dental Sciences,
Derlakatte, Mangaluru, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845827259 |
| Fax |
|
| Email |
upasana.reddy.88@gmail.com |
|
|
Source of Monetary or Material Support
|
| A.B.Shetty Institute of dental sciences,
Nitte Deemed to be University,Derlakatte, Mangaluru, Karnataka 575018
|
|
|
Primary Sponsor
|
| Name |
Nitte Deemed to be University |
| Address |
A B Shetty Memorial Institute of Dental Sciences,
Derlakatte, Mangaluru, Karnataka 575018 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| UPASANA REDDY |
A.B.Shetty Memorial Institute of Dental Sciences |
Room number 3, Third floor, Dept of Cons Dent. and Endodontics,Derlakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA |
9845827259
upasana.reddy.88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nitte Central ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1.Fluoride containing tooth paste: |
a dentifrice containing 1.1% sodium fluoride will be assigned to 50 out of 150 of the patients to be used once daily |
| Comparator Agent |
2.Extra Virgin Coconut oil |
coconut oil containing 45-50% Lauric acid and monosaturated fatty acids will be assigned by random to 50 of the patients to be used as a mouth rinse once a day. |
| Comparator Agent |
3.CPP-ACP tooth cream |
A Tooth cream containing 10% Calcium Phosphopeptide - Amorphous Calcium Phosphate(CPP-ACP) and 0.2% Sodium Fluoride(NaF) will be assigned by random to 50 of the patients to be used once daily. |
| Intervention |
Evaluation of saliva and comparison of anti-caries agents for prevention of radiation caries among Head and Neck cancer patients undergoing radiotherapy |
1. To document the root caries index for subjects with head and neck cancers before starting radiotherapy, during radiotherapy and post radiotherapy in each study group.
2. To compare the changes in root caries index between the study groups at the 1st week, 6th ,12th and 24th week. (before and after radiotherapy)
3. To determine the most efficacious palliative oral care for radiation caries among patients undergoing radiotherapy for head and neck cancers.
4. To determine the quantity and quality of saliva before beginning radiation therapy, during radiotherapy and post radiation in each study group.
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-Patients diagnosed with head and neck cancer.
- Patients undergoing radiotherapy with IMRT
-older than 12 years old age
|
|
| ExclusionCriteria |
| Details |
- Patients not undergoing radiotherapy
-stage III and stage IV patients with trismus having restricted mouth opening
-patients undergoing surgery
-patients undergoing chemotherapy
-patients suffering from other systemic conditions
-Subjects those who have history of allergy to oil use
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| root caries index (RCI) for each subject will be calculated |
To compare the changes in root caries index between the study groups at the 1st week, 6th ,12th and 24th week. (before and after radiotherapy) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the quantity and quality of saliva between the study groups using saliva kits. |
To compare the quantity and quality of saliva between the study groups at the 1st week, 6th ,12th and 24th week. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
18/03/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"none yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Every year an increase of head and neck malignancy patients are
diagnosed all over the world.Radiotherapy (RT) is the most preferred treatment choice however
it is associated with many undesired side effects.RT effects the salivary
glands resulting in changes in the oral flora favouring cariogenic organisms
and an increased susceptibility to caries.Irradiated patients are at increased risk for development of a
rapid, rampant carious process known as radiation caries.Dental
caries in patients undergoing radiotherapy may develop fast, as early as 3
month’s post radiation. Lesions typically in the cervical third of tooth.Prevention
is far more important than its treatment due to the complex anatomy of the
dentin on root surfaces which is far more soluble than enamel, as a result root
caries lesions may progress at rapid rate compared to coronal caries.However,
the precise incidence and prevalence of radiotherapy induced side effects and
root caries sequelae are still to be obtained as it is one of the most common
occurrence post radiation.
Hence the aim of this study is to assess the nature of saliva
for subjects undergoing radiation therapy by
determining the quantity and quality of saliva before beginning radiation,
during and post therapy in each study group.
We also want to evaluate
the effect of three anti-caries agents like a fluoride containing toothpaste,
virgin coconut oil rinse and a Calcium Phosphopeptide - Amorphous
Calcium Phosphate (CPP-ACP) containing tooth cream to be used on a daily basis
among subjects undergoing radiotherapy for
head and neck cancers. |