The prophylactic effect of air-powder plashing versus robber-cap plashing on plaque removal & brackets debonding in orthodontic patients: a double blind randomized clinical trial
Objectives: To assess the effect of air-powder plashing versus robber-cap plashing on plaque removal & brackets debonding in orthodontic patients.
Design: a double blind randomized clinical trial.
Setting and conduct: The eligible patients who underwent orthodontic procedure who will refer to Dr Poormoradi's private clinic during the study period will be enrolled into the trial.
Inclusion criteria: (a) orthodontic procedure on both of the jaws; (b) plaque index equal to or greater than 30.
Exclusion criteria: (a) having cardiovascular disease or hypertension; (b) contraindication of sodium use regiment; (c) having gum erosion.
Intervention: Prophylactic treatment with air-powder plashing once.
Control: Prophylactic treatment with robber-cap plashing once.
Primary outcome: Measuring the plaque index of all teeth before and after the intervention using O’leary index.
Secondary outcome: Measuring brackets debonding before and after the intervention through physical examination.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506029014N65
Registration date:2015-06-06, 1394/03/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-06, 1394/03/16
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-12-29, 1393/10/08
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The prophylactic effect of air-powder plashing versus robber-cap plashing on plaque removal & brackets debonding in orthodontic patients: a double blind randomized clinical trial
Public title
The prophylactic effect of air-powder plashing versus robber-cap plashing on plaque removal & brackets debonding in orthodontic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) orthodontic procedure on both of the jaws; (b) plaque index equal to or greater than 30.
Exclusion criteria: (a) having cardiovascular disease or hypertension; (b) contraindication of sodium use regiment; (c) having gum erosion.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the upper and lower jaws in every patient to the either of interventions one at a time.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid
City
Hamadan
Postal code
6517838695
Approval date
2015-01-20, 1393/10/30
Ethics committee reference number
D/P/16/35/9/4781
Health conditions studied
1
Description of health condition studied
orthodontics
ICD-10 code
Z46.4
ICD-10 code description
Fitting and adjustment of orthodontic device
Primary outcomes
1
Description
Measuring the plaque index of all teeth
Timepoint
before and after the intervention
Method of measurement
using O’leary index
Secondary outcomes
1
Description
Measuring brackets debonding
Timepoint
before and after the intervention
Method of measurement
through physical examination
Intervention groups
1
Description
Prophylactic treatment with air-powder plashing once
Category
Treatment - Other
2
Description
Prophylactic treatment with robber-cap plashing once
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Poormoradi's private clinic
Full name of responsible person
Dr Banafshe Poormoradi
Street address
Dr Poormoradi's private clinic, Buali Ave
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Dentistry School
Full name of responsible person
Faeze behgozin
Position
Faeze behgozin
Other areas of specialty/work
Street address
Dentistry School, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1086
Fax
Email
behgozin.faeze@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dentistry School
Full name of responsible person
Dr Banafshe Poormoradi
Position
Peroidontist
Other areas of specialty/work
Street address
Dentistry School, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1086
Fax
Email
b.moradi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)