Evaluation of the effect of Chitosan mouthwash on plaque and gingival indices in fixed orthodontic patients
Design
A clinical trial with a control group, with a parallel group design, double-blind, randomized, phase 3 on 22 patients, the block randomization method was used for randomization and the selection of these blocks will be using a random number table.
Settings and conduct
All patients attending Arak Mehrgan dental clinic who are undergoing orthodontic treatment will be selected. They will be given hygiene education to use dental floss and toothbrush. The study will be double-blind, in which the patients and the researcher will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People who do not have dental caries, disease and periodontal surgery and have not used antibiotics in the last three months. Non-inclusion criteria: infection in the last six months, diabetes, smoking, alcohol consumption, pregnancy, cancer, drug use that affects periodontal conditions, and systemic conditions requiring anti-prophylaxis.
Intervention groups
Intervention group: Chitosan mouthwash (twice a day) will be used.
Control group: mouthwash without chitosan (2 times a day) will be used.
Main outcome variables
Probe depth above 3 mm; Bleeding on probing; gingival index; plaque index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220611055141N1
Registration date:2022-08-16, 1401/05/25
Registration timing:prospective
Last update:2022-08-16, 1401/05/25
Update count:0
Registration date
2022-08-16, 1401/05/25
Registrant information
Name
Amirmohammad Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3624 1029
Email address
amirjafari7698@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-06, 1401/06/15
Expected recruitment end date
2022-11-06, 1401/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of chitosan mouthwash and chitosan-free mouthwash on plaque and gingival indices of fixed orthodontic patients
Public title
The effect of chitosan mouthwash on plaque and gingival indices in patients with fix orthodontic
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No dental caries
No disease and periodontal surgery
not used antibiotics in the last three months
Exclusion criteria:
Infection in the last six months
diabetes
smoking
Consumption of alcohol
Pregnancy
Cancer
Taking medications that affect periodontal conditions
Systemic conditions require antibiotic prophylaxis prior to periodontal examination
Patients who have a history of fixed orthodontic treatment in the past or any dental treatment during the study
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used. For this purpose, using blocks of size 4 including AABB, ABAB, BBAA, etc. is used and selected.
These blocks will be selected using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blind, in which the patients and the researcher, who is a dentist trained by periodontics specialist will be blind. In this way, patients and researchers in both mouthwash groups will not notice the difference between the mouthwashes due to the similar appearance of the mouthwash bottles.
The result information is also provided by a dentist trained by a periodontics specialist who does not know which group the patient is in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Payambar Azam Complex, Sardasht
City
arak
Province
Markazi
Postal code
3848170002
Approval date
2022-05-15, 1401/02/25
Ethics committee reference number
IR.ARAKMU.REC.1401.052
Health conditions studied
1
Description of health condition studied
PD (Probe Depth); BOP (Probe on Bleeding); PI (Plaque Index); GI (Gingival Index)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
probe depth above 3 mm
Timepoint
Probe depth measurement at the beginning of the study and 30 days after using the mouthwash
Method of measurement
With a Michigan calibrated periodontal probe
2
Description
bleeding on probing
Timepoint
Measurement of bleeding during probing at the beginning of the study and 30 days after using the mouthwash
Method of measurement
With a Michigan calibrated periodontal probe
3
Description
gingival index
Timepoint
Measurement of gingival index at the beginning of the study and 30 days after using the mouthwash
Method of measurement
Observational
4
Description
plaque index
Timepoint
Measuring the plaque index at the beginning of the study and 30 days after using the mouthwash
Method of measurement
The degree of staining of dental plaque after using Fuchsin tablets
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Chitosan mouthwash (2 times a day) will be used. Patients should rinse 10cc of mouthwash for 60 seconds at a time and do not consume anything until 30 minutes later .Low molecular weight (75% <DD <85%, MW 107 kDa) and high (75% <DD, MW 624 kDa) chitosan produced by Sigma-Aldrich, St. Louis, USA, for the production of mouthwash will be. Chitosan mouthwash will be produced with 0.4% v / v dose and PH = 5. This compound will be composed of 0.5% (W / V) NaCl salt, 1% (W / V) of Arabic gum stabilizer and 5% (W / V) of Mannitol. After complete solution, food flavor and food coloring are added at a dose of 0.1% (V / V).
Category
Treatment - Drugs
2
Description
Control group: mouthwash without chitosan (2 times a day) will be used. Patients should rinse 10cc of the mouthwash for 60 seconds and not consume anything for 30 minutes after that. Chitosan-free mouthwash with PH=5 will be produced. This composition will be formed with 0.5% (W/V) NaCl salt, 1% (W/V) of Arabic gum stabilizer and 5% (W/V) of Mannitol. After the complete solution, food flavoring and food colors are added at a dose of 0.1% (V/V). Chitosan-free mouthwash is used as a placebo and contains the ingredients mentioned above with the same pH; It is prepared without the main ingredient, which is chitosan. This mouthwash is prepared from the same company from which the original mouthwash is purchased. The container containing the mouthwash and the witness will be similar in appearance so that patients do not notice the difference.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehrgan Dental Clinic
Full name of responsible person
Mehdi Mikalani
Street address
Shahid Beheshti Street
City
Arak
Province
Markazi
Postal code
3848170001
Phone
+98 933 463 7885
Email
m.mikelani000@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Basij Square
City
َArak
Province
Markazi
Postal code
7000238481
Phone
+98 86 3417 3532
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?