Studying tooth color alteration after fixed orthodontic treatment with two techniques of tungsten carbide bur and composite bur for composite removal in patients undergoing fixed orthodontic treatment
The aim of the present clinical research is to study tooth color alteration after orthodontic treatment by removing the composite with two techniques of tungsten carbide bur and composite bur. The study will be done single blind in multiple centers on four anterior upper jaw teeth in 23 patients (92 tooth units). At the end of the orthodontic treatment debonding and composite removal will be done by two techniques of composite bur and tungsten carbide bur. Then tooth parameters will be measure by spectrophotometry right after debonding and two months afterward to determine the level of tooth color alteration. All patients undergoing the final stage of fixed orthodontic treatment are fit for the study. It is noteworthy to mention that the four anterior teeth have to be without any cavity and dental fillings. We hope that by studying tooth color alteration and color parameters in two groups of tungsten carbide bur and composite bur, we can obtain a technique that leads to minimal tooth color alteration level after orthodontic treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017013132323N1
Registration date:2017-04-04, 1396/01/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-04, 1396/01/15
Registrant information
Name
Amir Hooman Sadr Haghighi
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3327 1719
Email address
sadrehagigya@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2017-02-11, 1395/11/23
Expected recruitment end date
2017-08-03, 1396/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying tooth color alteration after fixed orthodontic treatment with two techniques of tungsten carbide bur and composite bur for composite removal in patients undergoing fixed orthodontic treatment
Public title
Tooth color alteration after orthodontic treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: The existence intact maxillary central and lateral incisors restored after the fixed orthodontic;the patient's written informed consent to participate in the study, which will be charged at the beginning
Exclusion criteria: crown or filling in the maxillary anterior teeth; patients with White spot lesion in four maxillary anterior teeth ; Patients who have the history of trauma in maxillary anterior teeth; Patients who have root canal therapy in maxillary anterior teeth; patients with missing maxillary anterior teeth; Patients with poor oral health
Age
From 12 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
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 Medical Sciences, Golgasht Street Tabriz
City
Tabriz
Postal code
Approval date
2017-02-09, 1395/11/21
Ethics committee reference number
IR.TBZMED.REC.1395.1176
Health conditions studied
1
Description of health condition studied
Tooth color alteration after orthodontic treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Tooth discoloration
Timepoint
Right after deboding and two months afterward
Method of measurement
By spectrophotometry
Secondary outcomes
1
Description
Alteration of color parameters
Timepoint
Right after deboding and two months afterward
Method of measurement
By spectrophotometry
Intervention groups
1
Description
Tungsten carbide bur control group
Category
Prevention
2
Description
Composite bur intervention group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of orthodotics, Dentistry Faculty, Medical University of Tabriz
Full name of responsible person
Amir Hooman Sadr Haghighi
Street address
Department of orthodotics, Dentistry Faculty, Medical University of Tabriz, Golgasht St.
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
Mohammad Rashidi
Street address
Vice chancellor for research and technology, Medical University of Tabriz, Golgasht St.
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 orthodotics, Dentistry Faculty, Medical University of Tabriz
Full name of responsible person
Amir Hooman Sadr Haghighi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of orthodotics, Dentistry Faculty, Medical University of Tabriz, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 3335 5966
Fax
Email
hooman_sadr7@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of orthodotics, Dentistry Faculty, Medical University of Tabriz
Full name of responsible person
Amir Hooman Sadr Haghighi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of orthodotics, Dentistry Faculty, Medical University of Tabriz, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 3335 5966
Fax
Email
hooman_sadr7@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of orthodotics, Dentistry Faculty, Medical University of Tabriz
Full name of responsible person
Hamed Alipour Milajerdi
Position
Undergraduate dental students
Other areas of specialty/work
Street address
Department of orthodotics, Dentistry Faculty, Medical University of Tabriz, Golgasht St.
City
Tabriz
Postal code
Phone
+98 413335596
Fax
Email
hamedalip@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)