Determining the antimicrobial effect of acrylic resin containing 5% CurNisNp on the Streptococcus mutans population in patients with removable acrylic resin appliances
Design
Two-arm parallel group, double-blind, randomized, on 24 patients (case + intervention group + comparison group). A simple random method was used for randomization using a sealed envelope.
Settings and conduct
Field: Antimicrobial photodynamic therapy
Place: Faculty of Dentistry, Shahid University, and Department of Microbiology, TUMS.
Patients are divided into 2 intervention (A) and comparison (B) groups (n=12). Before the intervention, saliva was taken to determine the load of S. mutans (SM), and the appliance with 5% CurNisNp was applied and exposed to LED (450 nm, 5 min) (photodynamic therapy). Then saliva is collected for determination of the load of SM. In the monthly visit before and after irradiation, the load of SM is determined. Group B was the same as Group A, except that the appliance did not have the nanoparticles and they did not receive LEDs. The Microbiologist and orthodontist are blinded by coding the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- At least 20 permanent teeth
Exclusion criteria:
Extensive fillings, Underlying diseases, Periodontal diseases, Antibiotic use in less than 1 month, and Absence of S. mutans in Baseline
Intervention groups
- The intervention group includes patients who receive removable appliances containing 5% curcumin-nisin poly-lactic acid nanoparticles and LED radiation in monthly periodic visits (photodynamic therapy) for 6 months.
- The comparison group includes patients who receive the removable appliances without curcumin-nisin poly-lactic acid nanoparticles and without LED radiation in monthly periodic visits (photodynamic therapy) for 6 months.
Main outcome variables
Changes in the amount of Streptococcus mutans in saliva samples
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230223057507N1
Registration date:2023-06-04, 1402/03/14
Registration timing:registered_while_recruiting
Last update:2023-06-04, 1402/03/14
Update count:0
Registration date
2023-06-04, 1402/03/14
Registrant information
Name
Abbas Bahador
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5810
Email address
abahador@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2025-04-04, 1404/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of antimicrobial photodynamic therapy effects of orthodontic resin acrylic containing Curcumin-nisin poly-lactic acid nanoparticles (CurNisNp): A randomized, double-blind case-control clinical trial
Public title
Investigating the effect of photodynamic therapy in reducing caries in removable orthodontics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Has at least 20 permanent teeth
Treatment plan with movable orthodontic appliance (acrylic).
Exclusion criteria:
Extensive tooth fillings
Removable denture
Underlying diseases
Periodontal diseases
Tooth loss due to extensive caries
Use of antibiotics in less than 1 month
Lack of Streptococcus mutans in the screening phase (Base line)
Number and coding for groups and patients in such a way that the microbiologist and orthodontist are not aware of the assigned code for groups and individuals.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofTehran University of Medical Sciences
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-02-12, 1401/11/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.754
Health conditions studied
1
Description of health condition studied
orthodontics
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changing the population of effective bacteria in dental caries
Timepoint
Measuring the population of Streptococcus mutans at the beginning of the study (before the start of the intervention) and 30, 60, 90, 120, 150 and 180 days after using the removable acrylic resin appliance
Method of measurement
Counting of bacterial population via serial dilution
Secondary outcomes
empty
Intervention groups
1
Description
The device used in the intervention group is a removable appliance made of acrylic methacrylate (Sigma-Aldrich) containing 5% curcumin-nisin poly-lactic acid nanoparticles. The curcumin, nisin, and lactic acid nanoparticles are obtained from Merck and Sigma-Aldrich, Germany. After making a mold of the patient's mouth and creating the removable appliance with the nanoparticles, the appliance is immediately placed in the patient's mouth, and the mouth is exposed to LED radiation (wavelength 450 nm, 5 minutes) for photodynamic therapy. Saliva is collected from the patient after the treatment. The removable appliance remains in the patient's mouth for 6 months, and at monthly visits before and after LED irradiation, unstimulated saliva preparation is conducted to determine the population of S. mutans.
Category
Treatment - Devices
2
Description
In the comparison group, a removable appliance was used as the device. The appliance was manufactured using only acrylic methacrylate (made by Sigma-Aldrich, Germany). After making a mold of the patient's mouth, the removable appliance was placed in the patient's mouth, and saliva was obtained. The removable appliance remained in the patient's mouth for 6 months, and at monthly visits, saliva preparation was conducted to determine the population of S. mutans.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
aculty of Dentistry, Shahid University
Full name of responsible person
Dr. Roghayeh Ghorbanzadeh
Street address
Enghelab Ave, Qods Ave, Italia Ave,
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 5810
Email
ab.bahador@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Bahador
Street address
Enghelab Ave.,
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 5810
Email
ab.bahador@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Abbas Bahador
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Laboratory Medicine
Street address
Enghelab Ave.,
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 5810
Email
ab.bahador@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Bahador
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Laboratory Medicine
Street address
Poursina
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 5810
Fax
+98 21 8895 5810
Email
abahador@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Bahador
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Laboratory Medicine
Street address
Poursina
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 5810
Fax
+98 21 8895 5810
Email
abahador@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Non-identifiable personal data of participants is not important for publication.
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