In this single blind, single center and parallel randomized clinical trial study, 54 patients are randomly categorized into three groups; which are Control group, Ortho-Kin mouth rinse usage group and herbal antiseptic Persica mouth rinse. It is worth noting that each group includes 18 person. All periodontal indexes including Gingival Index (GI), Gingival Blooding Index (GBI) and O’Leary plaque index (PI) are measured using periodontal William’s probe, before starting fixed orthodontic treatment. In the first appointment, all healthy rules including the correct method of tooth brushing, the way of using dental floss and Interdental toothbrushes are trained, after placing brackets on teethes. Given periodontal indexes will be analyzed again after three months. Patients in “Ortho-Kin mouth rinse usage group” Should gurgle 15 ml mouth rinse for 30 minutes twice a day and avoid eating or drinking for about 30 minutes after applying mouth rinse (according to instruction). Patients in “Persica usage group” should instill 10 drops into spoon and then gurgle for 30 minutes three times a day (according to instruction) and patients in “Controlling group” consume placebo synthetic mouth rinse.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016033024573N2
Registration date:2016-06-06, 1395/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-06, 1395/03/17
Registrant information
Name
Mohadeseh Heidari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8351
Email address
mheidari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2016-04-15, 1395/01/27
Expected recruitment end date
2016-08-15, 1395/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Fixed Orthodontic Treatment and Two Mouthrinses on Gingival Health: A Single blind placebo controlled clinical trial.
Public title
Comparing the effect of Orthokin and Persica mouthrinses on periodontal condition in fixed orthodontic patients treated in privet office in year 1395
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Patients should be under fixed double jaw orthodontic treatment; Patients should not have usage of antibiotic and mouth-rinsing experience; Patients should not have numerous severe dental caries and/or restorations; Patients should not have severe dental plaque/ severe Gingival inflammation; Patients should not have periodontal surgery or periodontal disease experience; Patients should not have systemic disease.
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committe of Mazandaran university of medical sciences
Street address
Research Department, Moallem square, Moallem avenue, Sari, Iran.
City
Sari
Postal code
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.MAZUMS.REC.94.1217
Health conditions studied
1
Description of health condition studied
Effect of fix orthodontic treatment and two mouthrinses on periodontal condition.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plaque index
Timepoint
Before bonding, 3 month after treatment start, 1 month after mouthrinse nad placebo
Method of measurement
Observation scoring by disclosing agent
Secondary outcomes
1
Description
Gingival bleeding index
Timepoint
3 month after treatment
Method of measurement
Visual scale by probing
Intervention groups
1
Description
Intervention: drug (mouth rinse) should be applied twice a day (preferably after each meal), as doses of 15 mL used for 30 seconds. Patients should avoid eating or drinking for about 30 minutes after applying mouthwash.
Category
Treatment - Drugs
2
Description
Control: placebo solution containing 35 cc glycerine, 35 cc distilled water, and 0.3 cc ethylene blue per 100 cc.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthodontic, Dental Faculty, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Sepideh Dadgar and Shohreh Keikavousi
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
Research Department, Moallem square
City
Sari
Grant name
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Orthodontics, Dental Faculty of Sari, Mazandaran University of Medical Sciences.
Full name of responsible person
Farhad Sobouti
Position
Deputy Research of Dental Faculty/ Assisstant professor
Other areas of specialty/work
Street address
Touba clinic, Orthotontic department, Dental faculty,Mazandaran university of medical sciences