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A clinical trial for comparison the effect of two mouthwashes, Persica and Chlorhexidine, on surface characterization and static friction between wire and bracket in orthodontic patients.

Protocol summary

Summary
Title: A clinical trial for comparison the effect of two mouthwashes, Persica and Chlorhexidine, on surface characterization and static friction between wire and bracket in orthodontic patients Objectives: Evaluation and comparison of changes in surface roughness and friction of orthodontic wires and brackets with Chlorhexidine and Persica mouthwashes Design: Interventional Setting and conduct: Three groups composed of 20 orthodontic patients who have inclusion criteria, at certain stage of treatment will be assumed as Persica group, Chlorhexidine group and control group. Chlorhexidine Group: Twenty stainless steel 0.019*0.025 inch orthodontic arch wires and 20 additional stainless steel brackets in the correct stage of treatment will be inserted in fixed orthodontic appliance. Chlorhexidine mouthwash will be prescribed according to anti inflammatory regiment. A predetermined amount of the mouthwash will be used twice daily for two weeks. Each rinsing time is set 30 seconds. After day 14, the patient will be visited and the wire with the bracket, which is just ligated to the wire, will be removed. The wire will be replaced with an appropriate wire. Persica Group: Twenty stainless steel 0.019*0.025 inch orthodontic arch wires and 20 additional stainless steel brackets in the correct stage of treatment will be inserted in fixed orthodontic appliance. Persica mouthwash will be prescribed according to current hygienic protocols and previous studies. The patient will be educated to dissolve 15 cc of the mouthwash in 15 cc water, completely shake and then rinse for 30 seconds. After day 14, the patient will be visited and the wire with the bracket will be removed. The wire will be replaced with an appropriate wire. To omit the abrasive effects of oral hygiene care materials, a similar toothpaste and interdental brush will be given to each patient. Control Group: Twenty stainless steel 0.019*0.025 inch orthodontic arch wires and 20 additional stainless steel brackets in the correct stage of treatment will be inserted in fixed orthodontic appliance. In this group, after insertion of brackets and wires, only toothpaste and toothbrushes will be given to patients for daily oral hygiene care. After day 14, the patient will be visited and the wire with the bracket will be removed. The wire will be replaced with an appropriate wire. The wires and brackets, after removal, will be cleaned with ethanol alcohol and a cotton roll. Insertion and removal of the wires and brackets will be performed by one clinician. Surface characterization of brackets and wires, after applying ultrasonic, will be assessed before and after the intervention. Static friction between wire and brackets will be assessed with Universal Testing Machine. Surface characterization of wires and brackets will be assessed with Atomic Force Microscope and Scanning Electron Microscope respectively. Major inclusion and exclusion criteria: Inclusion criteria: Ability to control oral hygiene. Exclusion criteria: Metabolic and systemic diseases; Salivary gland diseases; Consuming medications that affect amount or consistency of saliva; Consuming any other mouthrinse; Cigarette smoking; Drug abusing; Pregnancy or breast feeding. Interventions: Chlorhexidine and Persica mouthwashes Main outcome measures (variables): 1. Surface characterization of orthodontic wire 2. Surface charachterization of brackets 3. Static friction between orthodontic wire and bracket

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2014032117067N1
Registration date: 2014-09-03, 1393/06/12
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-09-03, 1393/06/12
Registrant information
Name
Elham sadat Emadian razavi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 1162
Email address
e-emadian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-12-31, 1393/10/10
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial for comparison the effect of two mouthwashes, Persica and Chlorhexidine, on surface characterization and static friction between wire and bracket in orthodontic patients.
Public title
Evaluation the effect of two mouthwashes on surface characterization of orthodontic wire and bracket and friction between bracket and wire
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Ability to control oral hygiene. Exclusion criteria: Metabolic and systemic diseases; Salivary gland diseases; Consuming medications that affect amount or consistency of saliva; Consuming any other mouthrinse; Cigarette smoking; Drug abusing; Pregnancy or breast feeding
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In order to randomized assignment of samples, three folded paper cards were used.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Enqelab Square, Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2014-05-05, 1393/02/15
Ethics committee reference number
92-03-70-23963-106585

Health conditions studied

1

Description of health condition studied
Surface characterizations of orthodontic wire and bracket and static friction between wire and bracket in dry state
ICD-10 code
T78.8
ICD-10 code description
Other adverse effects, not elsewhere classified

Primary outcomes

1

Description
Surface characterization of orthodontic wire
Timepoint
Two weeks
Method of measurement
Atomic Force Microsccope

2

Description
Surface charachterization of brackets
Timepoint
Two weeks
Method of measurement
Scanning Electron Microscope

3

Description
Static friction between orthodontic wire and bracket
Timepoint
Two weeks
Method of measurement
Universal Testing Machine

Secondary outcomes

empty

Intervention groups

1

Description
Intervention name: Chlorhexidine gluconate 0.2% Administration: The mouth is rinsed with 30 ml (2 Tablespoons) of undiluted chlorhexidine twice daily (morning and night) for 30 seconds after brushing for two weeks. Individuals must expectorate the chlorhexidine after rinsing and must not rinse their mouths with water or mouthwashes, brush their teeth, or eat immediately after using chlorhexidine. Patients should clean their teeth with Oral-B tooth brush and Crest, Gum Protection tooth paste.
Category
Treatment - Drugs

2

Description
Intervention name: Persica Administration: The mouth is rinsed with 30 ml (2 Tablespoons) of diluted Persica (15 mlit Persica and 15 mlit water), twice daily (morning and night) for 30 seconds after brushing for two weeks. Patients should clean their teeth with Oral-B tooth brush and Crest, Gum Protection tooth paste.
Category
Treatment - Drugs

3

Description
Control: Active control Patients should clean their teeth with Oral-B tooth brush and Crest, Gum Protection tooth paste.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthodontic Department, Dental School, Tehran University of Medical Sciences
Full name of responsible person
Mrs. Saeedeh Sharafi
Street address
North Kargar St., Dental School
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ms. Elahe Alamdar
Street address
Enqelab St., Tehran University of Medical Sciences, Dental Research Center
City
Tehran
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
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, Faculty of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Elham sadat Emadian Razavi
Position
Assistant of Orthodontics
Other areas of specialty/work
Street address
North Kargar st., Department of Orthodontics, Faculty of Dentistry, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8897 7921
Fax
-
Email
e-emadian@razi.tums.ac.ir
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tahereh Hosseinzadeh Nik
Position
Professor
Other areas of specialty/work
Street address
North Kargar st., Department of Orthodontics, Faculty of Dentistry, Tehran University of Medical Sciences
City
Tehran
Postal code
-
Phone
+98 21 8897 7921
Fax
-
Email
hoseinit@tums.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham sadat Emadian Razavi
Position
Assistant of Orthodontics
Other areas of specialty/work
Street address
North Kargar st., Department of Orthodontics, Faculty of Dentistry, Tehran University of Medical Sciences
City
Tehran
Postal code
-
Phone
-
Fax
-
Email
e-emadian@razi.tums.ac.ir
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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