| CTRI Number |
CTRI/2024/02/062872 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [mouthwash] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of mouthwash on oral ulcers in cancer patients undergoing chemotherapy- a randomized clinical trial |
|
Scientific Title of Study
|
Effect of zinc chloride mouthwash on oral mucositis in cancer patients undergoing chemotherapy- a randomized clinical trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Bhargavi |
| Designation |
Postgraduate |
| Affiliation |
sibar institute of dental sciences |
| Address |
Sibar institue of dental sciences, department of public health
dentistry, room no.10, takellapadu, guntur, andhra pradesh
Guntur
ANDHRA PRADESH
522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9441072131 |
| Fax |
|
| Email |
kotabhargavi9848@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Srinivas |
| Designation |
Professor and Head of the department |
| Affiliation |
sibar institute of dental sciences |
| Address |
Sibar institue of dental sciences, department of public health
dentistry, room no.10, takellapadu, guntur, andhra pradesh
Guntur
ANDHRA PRADESH
522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9849368466 |
| Fax |
|
| Email |
srinivaspachava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Devaki |
| Designation |
Professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
Sibar institue of dental sciences, department of public health
dentistry, room no.10, takellapadu, guntur, andhra pradesh
Guntur
ANDHRA PRADESH
522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9441306737 |
| Fax |
|
| Email |
devakitalluri@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental sciences, takellapadu, guntur, andhra pradesh |
|
|
Primary Sponsor
|
| Name |
Dr L Krishna Prasad |
| Address |
Sibar institute of dental sciences, takellapadu, guntur, andhra pradesh
|
| Type of Sponsor |
Other [Self] |
|
|
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 |
| K Bhargavi |
Omega cancer hospital |
Department of surgical oncology
grand trunk road,
guntur
Guntur
ANDHRA PRADESH |
9441072131
kotabhargavi9848@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar institute of dental sciences, takellapadu, guntur, andhra pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
mouthwash without zinc chloride |
All subjects will be instructed to use mouth wash given to them accordingly (i.e; mouthwash without ZnCl) for every 8hrs for 2 weeks, At the end of 2 weeks all the subjects in both the groups will be examined for oral mucositis. |
| Intervention |
zinc chloride mouthwash |
All subjects will be instructed to use mouth wash given to them accordingly (i.e; ZnCl mouthwash) for every 8hrs for 2 weeks, At the end of 2 weeks all the subjects in both the groups will be examined for oral mucositis. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cancer patients having oral mucositis following Chemotherapy after 24 hours.
Patients who provide consent form
|
|
| ExclusionCriteria |
| Details |
Patients having any oral cancers
Patients who are in critical condition
Patients who are not willing to participate
Patients having grade 0 oral mucositis score
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral mucositis score |
Baseline & after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| weight |
Baseline & after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/03/2024 |
| Date of Study Completion (India) |
29/09/2024 |
| Date of First Enrollment (Global) |
05/03/2024 |
| Date of Study Completion (Global) |
29/09/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
subjects included were cancer patients under going chemotherapy from one oncology hospital of Guntur city, will be selected through purposive sampling. The subjects will be randomly categorized into two groups by a single investigator using block randomization. The groups are named as group A- mouthwash without zinc chloride (control group) (Listerine mouthwash- Alcohol, Benzoic Acid, Caramel, Methyl Salicylate, Poloxamer 407, Sodium Benzoate, Water (eau)) & group B- mouthwash containing zinc chloride (experimental group) (Lupident mouthwash- zinc chloride, chlorhexidine gluconate, sodium fluoride), containing 21 in each group. subjects included in the study will be selected by using inclusion and exclusion criteria. oral mucositis scores will be recorded by using world health organization criteria for grading of oral mucositis. baseline data of oral mucositis score will be obtained using clinical examination and mouthwash will be provided to the subjects included in the study. All subjects will be instructed to use mouth wash given to them accordingly (i.e; ZnCl mouthwash for experimental group and mouthwash without ZnCl) for every 8hrs for 2 weeks. At the end of 2 weeks all the subjects in both the groups will be examined for oral mucositis scores. Comparision of both the groups will be done using statistical test |