Protocol summary

Study aim
Considering the importance of caries prevention during orthodontic treatment and the rate of caries, this study investigates the effects of photodynamic therapy by curcumin on the accumulation of Streptococcus mutans as the main cause of tooth decay and compares it with conventional orthokine mouthwash.
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, phase 2-3 on 105 patients. Excel software rand function was used for randomization.
Settings and conduct
The present study is an interventional study in which the effect of orthokine mouthwash and photocodynamic therapy by curcumin on Streptococcus mutans in patients undergoing orthodontic treatment in the specialized department of the Faculty of Dentistry of Kurdistan University of Medical Sciences will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Patient informed consent to participate in the study • Those who can receive fixed orthodontic treatment and can cooperate. • People who have had two to three months since starting orthodontic treatment • Individuals who did not receive any plaque removal treatment prior to enrollment. Exclusion criteria: Poor cooperation Periodontal diseases pregnant women Having systemic diseases affecting the quality and quantity of dental plaque Taking antibiotics History of radiotherapy A large number of decayed teeth
Intervention groups
1. Health controllers using toothbrushes and toothpaste containing fluoride alone (as a control group) 2. Hygiene controllers using toothbrush, toothpaste and orthokin mouthwash 3. Hygiene controllers using toothbrush and toothpaste with photodynamic therapy using curcumin
Main outcome variables
Determination of Streptococcus mutans

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201125049490N1
Registration date: 2021-01-06, 1399/10/17
Registration timing: retrospective

Last update: 2021-01-06, 1399/10/17
Update count: 0
Registration date
2021-01-06, 1399/10/17
Registrant information
Name
Elnaz Hajhemati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3322 7065
Email address
elnazhematy98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
2019-11-22, 1398/09/01
Actual recruitment end date
2020-05-21, 1399/03/01
Trial completion date
2020-09-22, 1399/07/01
Scientific title
Comparision of the effect of photodynamic therapy by Curcumin and Orthokine mouthwash on Streptococcal Mutans in Fix Orthodontic Patients
Public title
effect of photodynamic therapy by Curcumin mouthwash on Streptococcal Mutans
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient informed consent to participate in the study can receive fixed orthodontic treatment and can cooperate. People who have had two to three months since starting orthodontic treatment Individuals did not receive any plaque removal treatment prior to enrollment.
Exclusion criteria:
Poor cooperation Periodontal diseasespregnant womenHaving systemic diseases affecting the quality and quantity of dental plaque Taking antibiotics History of radiotherapy A large number of decayed teeth
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
Actual sample size reached: 105
Randomization (investigator's opinion)
Randomized
Randomization description
The conditions for studying and performing the plan will be fully explained to the patients. In the next step, randomization is divided into 3 groups (ABC) in random blocks using triple number tables. Then a pack containing 105 cards with one of the letters A = intervention group (35 pieces), B = control group B (35 pieces) and the third group C control B (35 pieces) is considered so that patients from within the package Randomly select a card and enter one of the groups according to the Latin letter. In this way, 35 people are assigned to each control and intervention group. Sampling is done in parallel in 3 groups until the number of samples is completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kurdistan Medical Sciences Ethics Committee
Street address
Pasdaran Street. Kurdistan University of Medical Sciences. dental College
City
SANANDAJ
Province
Kurdistan
Postal code
6616958452
Approval date
2020-11-16, 1399/08/26
Ethics committee reference number
IR.MUK.REC.1399.213

Health conditions studied

1

Description of health condition studied
Patients undergoing fixed orthodontic treatment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
photodynamic therapy with curcumin
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
By visible blue LED light

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group: Health controllers using toothbrush and toothpaste and photodynamic therapy using curocumin
Category
Treatment - Devices

2

Description
Control group: Hygiene controllers using toothbrush, toothpaste and ortokin mouthwash
Category
Treatment - Devices

3

Description
Control group: Hygiene controllers using toothbrushes and toothpaste
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Dentistry, Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Ilnaz Haj Hemmati
Street address
Pasdaran Street. Kurdistan Dental School of Medical Sciences
City
SANANDAJ
Province
Kurdistan
Postal code
6616958478
Phone
+98 87 3366 4652
Email
elnazhematy98@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. Ilnaz Haj Hemmati
Street address
Pasdaran Street. Kurdistan Dental School of Medical Sciences
City
sanandaj
Province
Kurdistan
Postal code
6616958478
Phone
+98 87 3366 4652
Email
elnazhematy98@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
50
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
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. Ilnaz Haj Hemmati
Position
asistans profossor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran St., School of Dentistry, Kurdistan University of Medical Sciences
City
sanandaj
Province
Kurdistan
Postal code
6616958478
Phone
+98 87 3366 4652
Email
elnazhematy98@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
dr elnaz haj hematy
Position
asistans profossor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran St., School of Dentistry, Kurdistan University of Medical Sciences
City
sanandaj
Province
Kurdistan
Postal code
6616958478
Phone
+98 87 3366 4652
Email
elnazhematy98@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
dr elnaz hajhematy
Position
asistans profossor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran St., School of Dentistry, Kurdistan University of Medical Sciences
City
sanandaj
Province
Kurdistan
Postal code
6616958478
Phone
+98 87 3366 4652
Email
elnazhemay98@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
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