The aim of this study is the enamel color change assessment at the end of the fixed orthodontic treatment and 10 weeks later after two different tooth cleaning techniques with using: carbide bur; carbide bur and polishing for remove remaining composite. This study is a randomized clinical trial and in a split mouth design.The samples are gathered from patients from executive office and two partners offices at 2016-2017. Inclusion criteria: intact central and lateral maxillary incisors; no tooth restoration; 12 to 35 years old patients; the patient at the end of fixed orthodontic treatment. Exclusion criteria: white spot lesion and restorative on maxilary central and lateral teeth; patient with poor oral hygiene. Sample size include 80 central and lateral incisors teeth (total of 160 teeth) on 40 patients. After the end of fixed orthodontic treatment the composite removes with carbide bur in both groups and in the intervention group in addition to removing composite with carbide bur, polishing does by Rubber cup and pumice (incisors and lateral in one side). The patients are not aware of the type of the instrument for removing composite and the polishing side but the clinician blinding is not possible. A comparison of color change between two groups in the period of 10 weeks does. This color change measure by the spectrophotometery device. Expected consequences is different discoloration between two groups after 10 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702219569N6
Registration date:2017-06-08, 1396/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-08, 1396/03/18
Registrant information
Name
Amir Mohammadi
Name of organization / entity
Department of Orthodontics of Dental Faculty of Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
mohammadia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tabriz university of medical sciences
Expected recruitment start date
2016-11-30, 1395/09/10
Expected recruitment end date
2017-04-25, 1396/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of polishing on enamel discoloration after the end of fixed orthodontic treatment
Public title
Evaluation the effect of polishing on next discoloration of teeth at the end of fixed orthodontic treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 12-35; patients at the end of orthodontic treatment.
Exclusion criteria: patients with crowns in four upper incisor teeth; patients with filling in the four upper incisor teeth; poor oral hygiene; patients with white spot lesion in four upper incisor teeth
Age
From 12 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
ٔRandlist software use for randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethics Committee of Tabriz University of Medical Sciences.vice chancellor for research of Tabriz University of Medical Sciences ,Tabriz University of
City
Tabriz
Postal code
Approval date
2017-04-10, 1396/01/21
Ethics committee reference number
IR.TBZMED.REC.1396.1
Health conditions studied
1
Description of health condition studied
Check discolored teeth after the end of treatment
ICD-10 code
ICD-10 code description
2
Description of health condition studied
malocclusion
ICD-10 code
K07.4
ICD-10 code description
Anomalies of dental arch relationship
Primary outcomes
1
Description
Tooth discoloration
Timepoint
teeth discolaration after 10 weeks of its debonded
Method of measurement
spectrophotometry device
Secondary outcomes
1
Description
L,a,b parameters for tooth color
Timepoint
Immediately after and within 10 weeks of its debonded
Method of measurement
spectrophotometry
Intervention groups
1
Description
Control group: no intervention.
Category
Prevention
2
Description
Intervention group: polishing after the end of orthodontic treatment and remove the bracket for 30 seconds by rubber cup and pumice .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Executive's office
Full name of responsible person
Amir Mohamadi, Assistant professor
Street address
Eskan building, Abresan Crossroad
City
Tabriz
2
Recruitment center
Name of recruitment center
Partner office
Full name of responsible person
Human Sadr Hagigi, Assistant professor
Street address
Azarbayjan building, 17 sharivar street
City
Tabriz
3
Recruitment center
Name of recruitment center
Partner office
Full name of responsible person
Arman Shayan, Assistant professor
Street address
Golgasht Threeway, Azadi street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tabriz university of medical sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Tabriz university of medical sciences, Golgasht street
City
Tabriz
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 of Tabriz 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 of Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Amir Mohammadi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Orthodontics, Tabriz Dental Faculty, Tabriz University of Medical Sciences,Golgasht St
City
Tabriz
Postal code
Phone
+98 41333335596
Fax
Email
amirortho@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Orthodontics of Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Amir Mohammadi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Orthodontics, Tabriz Dental Faculty, Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Postal code
Phone
+98 413333294312
Fax
Email
amirortho@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of orthodontics of dental faculty of university of medical science
Full name of responsible person
Milad Einibakhsh
Position
Undergraduate dental students
Other areas of specialty/work
Street address
Tabriz dental faculty, Tabriz university of medical sciences, Golgasht street
City
Tabriz
Postal code
Phone
00
Fax
Email
miladeinibakhsh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)