Comparison of Therapeutic Effect of Mouthwash Containing Matricaria chamomilla Extract and Nystatin Suspension on Patients with Denture Stomatitis- a randomized clinical trial
Determining the therapeutic effect of mouthwash containing chamomile extract compared to nystatin suspension in patients with denture stomatitis
Design
A single-blind, randomized clinical trial will be conducted on 24 patients with denture stomatitis. The rand function of Excel software will be used for randomization.
Settings and conduct
The location for collecting the necessary information will be Tooba Dental Clinic. The mouthwash will be manufactured at the Faculty of Pharmacy, Mazandaran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Healthy individuals with complete maxillary dentures and denture stomatitis (type II) will be included.
Patients with a history of using antifungal drugs, antibiotics and corticosteroids in the last month, allergy to nystatin, patients with immunodeficiency, Alzheimer's, psychological disorders, chewing muscle disorder, unable to use mouthwash, and patients with loose and discolored dentures will be excluded from the study.
Intervention groups
Two groups
Group 1 = receiving mouthwash containing chamomile
Group 2 = receiving nystatin suspension
Main outcome variables
Erythematous lesions are examined on days 0, 7, and 14.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241231064232N1
Registration date:2025-02-24, 1403/12/06
Registration timing:registered_while_recruiting
Last update:2025-02-24, 1403/12/06
Update count:0
Registration date
2025-02-24, 1403/12/06
Registrant information
Name
Pooya Rabiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 4894
Email address
pooyarabiee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Therapeutic Effect of Mouthwash Containing Matricaria chamomilla Extract and Nystatin Suspension on Patients with Denture Stomatitis- a randomized clinical trial
Public title
Comparing the effects of chamomilla mouthwash and nystatin in the treatment of denture stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy individuals with maxillary complete dentures and denture stomatitis (type II)
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be randomly assigned to two mouthwash groups (the RAND function in Excel will be used so that the values produced for each individual will be placed in the chamomile mouthwash group if less than 0.5 and in the nystatin mouthwash group if greater than 0.5).
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be single-blinded, and the only person recording changes in the groups will not be aware of the type of mouthwash.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
moallem
City
sari
Province
Mazandaran
Postal code
4815733971
Approval date
2024-12-25, 1403/10/05
Ethics committee reference number
IR.MAZUMS.REC.1403.411
Health conditions studied
1
Description of health condition studied
denture stomatitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
fungi load
Timepoint
day 0, 7, and 14
Method of measurement
Colony cultivation and counting
2
Description
lesion diameter
Timepoint
day 0, 7, and 14
Method of measurement
measuring with probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using mouthwash containing chamomile/ Patients are asked to swish 10 cc of chamomile mouthwash in their mouth 3 times (every 8 hours) and gargle for 1 minute, then spit it out, and avoid eating or drinking for at least 1 hour after using the mouthwash. Treatment will continue for 2 weeks, and erythematous lesions will be examined on days 0, 7, and 14.
Category
Treatment - Drugs
2
Description
Intervention group: Using nystatin suspension/ Patients are asked to place 20 drops (1 mL) of nystatin suspension 100,000u/ml in the mouth, gargle for 1 minute, then spit out, and refrain from eating or drinking for at least 1 hour after using the mouthwash. Treatment will continue for 2 weeks, and erythematous lesions will be assessed on days 0, 7, and 14.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
touba dental clinic
Full name of responsible person
دکتر محمد ابراهیمی ساروی
Street address
moallem
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3324 4014
Email
poyarabiee@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Parastoo Namdar
Street address
moallem
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3324 4014
Email
dds.pnamdar@gmail.com
Grant name
Research Center of Mazandaran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ebrahimi Saravi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
moallem
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3324 4014
Email
poyarabiee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ebrahimi Saravi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
moallem
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3324 4014
Email
poyarabiee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ebrahimi Saravi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
moallem
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3324 4014
Email
poyarabiee@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available