Protocol summary

Study aim
Determining the recurrence rate, patient's pain, pocket depth and gingival resorption after treatment of rotated teeth with fibrotomy with surgical razor alone, surgical razor and low power laser, diode laser alone, diode laser with low power laser and low power laser alone، one month later. Comparison of recurrence rate, patient's pain and pocket depth after treatment of rotated teeth with 5 different ways
Design
Clinical trial with control group, with parallel groups (6 groups in total), one-side blinded, randomized, on 90 patients. Random allocation process is performed with random allocation software.
Settings and conduct
The place is in the office of orthodontists. The data recorder, researcher and statistician goes blind
Participants/Inclusion and exclusion criteria
Patients undergoing fixed orthodontic treatment who were 15 to 30 years old at the beginning of treatment and had rotated teeth and are now at the end of their fixed treatment should have a rotation rate of 20 to 70 degrees. No systemic disease, gingivitis and periodontitis, proximal and deep caries, developmental and anatomical malformations, use of drugs that disrupt bone metabolism, conditions in which the use of lasers is prohibited, such as pregnancy. Patients should have good oral hygiene and plaque index under 10%
Intervention groups
fibrotomy with 1.surgical razor alone, 2.surgical razor and low power laser, 3.diode laser alone, 4.diode laser with low power laser, 5.low power laser alone 6.control group
Main outcome variables
Arch relapse rate; Depth of gingival sulcus; Depth of probing around the tooth; The amount of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210621051653N1
Registration date: 2021-08-04, 1400/05/13
Registration timing: registered_while_recruiting

Last update: 2021-08-04, 1400/05/13
Update count: 0
Registration date
2021-08-04, 1400/05/13
Registrant information
Name
Hanieh Rohaninezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3452 5770
Email address
hanieh.rohaninezhad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-28, 1400/05/06
Expected recruitment end date
2021-09-28, 1400/07/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment of rotated teeth relapse after orthodontic treatment via fibrotomy with scalpel and diode laser: A Randomized clinical trail
Public title
Assesment of rotated teeth relapse after orthodontic treatment via fibrotomy with scalpel and diode laser: A Randomized clinical trail
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing fixed orthodontic treatment who were 15 to 30 years old at the beginning of treatment and had rotated teeth and are now at the end of their fixed treatment should have a rotation rate of 20 to 70 degrees. Absence of systemic disease Absence of gingivitis and periodontitis, good oral hygiene, plaque index below 10% Absence of proximal caries and deep caries in the area of ​​cementoenamel junction (CEJ), absence of evolutionary and anatomical deformities Do not take drugs that disrupt bone metabolism Lack of conditions in which the use of lasers is prohibited, such as pregnancy
Exclusion criteria:
Teeth with periodontitis Tooth rotations greater than 70 degrees and less than 20 degrees Teeth with proximal caries or caries extending to the cementoenamel junction (CEJ) Taking drugs that affect bone metabolism
Age
From 15 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
From the samples with inclusion criteria, 90 rotated teeth are selected by the census. After recording the demographic information of patients, including age, sex, location, contact number, etc., using the blocking method, these 90 teeth will be assigned to six groups. The random allocation process will be done with Random allocation software. With this software, 15 six-block blocks are selected and the samples are divided into six groups based on these blocks. This is a one-sided blind study in which the person recording the rate of rotation and pain and the statistician do not know who is in which group and are not aware of the type of treatment. The patient and the treating specialist are aware of the treatment used and cannot be blinded.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a one-sided blind study in which the person recording the rate of rotation and pain and the statistician do not know who is in which group and are not aware of the type of treatment. The patient and the treating specialist are aware of the treatment used and cannot be blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Science
Street address
Narenj alley , Panzdah Khordad Ave
City
Sari
Province
Mazandaran
Postal code
4818865454
Approval date
2021-07-11, 1400/04/20
Ethics committee reference number
IR.MAZUMS..REC.1400.9105

Health conditions studied

1

Description of health condition studied
The rate of relapse after orthodontic treatment with fibrotomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The rate of relapse after orthodontic treatment with fibrotomy
Timepoint
The beginning of the study, one month after starting treatment
Method of measurement
Digimizer image analysis software

Secondary outcomes

1

Description
Depth of gingival sulcus
Timepoint
The beginning of the study, one month after treatment
Method of measurement
Using a periodontal probe

2

Description
Depth of probing around the teeth
Timepoint
The beginning of the study, one month after treatment
Method of measurement
Using a periodontal probe

3

Description
The amount of pain
Timepoint
The beginning of the study, one month after treatment
Method of measurement
VAS scale

Intervention groups

1

Description
Intervention group: Fibrotomy with a surgical razor
Category
Treatment - Devices

2

Description
Intervention group: Low power laser fibrotomy only (by Biolase EPIC X laser diode USA, wavelength 940 nm)
Category
Treatment - Devices

3

Description
Intervention group: Laser Fibrotomy with Surgical Laser Alone (Biolase EPIC X Laser Diode USA)
Category
Treatment - Devices

4

Description
Intervention group: Fibrotomy with Laser surgery combined with low power laser
Category
Treatment - Devices

5

Description
Intervention group: Perform fibrotomy first and then low power diode laser radiation
Category
Treatment - Devices

6

Description
Control group: without interfering
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Private orthodontic office
Full name of responsible person
Hanieh Rohaninezhad
Street address
Sadaf Department, Panzdah khordad Ave, Sari Town
City
Sari
Province
Mazandaran
Postal code
4851648573
Phone
+98 11 3326 3345
Email
hanieh.rohaninezhad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Farah abad
City
Sari
Province
Mazandaran
Postal code
Phone
+98 11 3304 4000
Email
ict@mazums.ac.ir
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
70
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
avideh maboudi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Panzdah khordad Ave
City
Sari
Province
Mazandaran
Postal code
4818865454
Phone
+98 11 3326 3345
Email
Avideh48188@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Avideh Maboudi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Panzdah khordad Ave
City
Sari
Province
Mazandaran
Postal code
4818865454
Phone
+98 11 3326 3345
Email
Avideh48188@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Avideh Maboudi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Panzdah khordad Ave
City
Sari
Province
Mazandaran
Postal code
4818865454
Phone
+98 11 3326 3345
Email
Avideh48188@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data file of the participants will generally be sent along with the submission of the research article after being unidentifiable The study protocol will be fully explained in the text of the article The cases and map of statistical analysis and the results that need to be mentioned in the text of the article are given Patients' informed consent form must be published as an attachment The report of what will be seen in the clinic will be mentioned as results in the text of the article.
When the data will become available and for how long
From 2021 to one year after the publication of the results
To whom data/document is available
Journal Referees. Anyone who intends to conduct further studies in this field will receive the documentation by sending an email to the responsible author.
Under which criteria data/document could be used
People who want to do further studies in this field. There is no obstacle
From where data/document is obtainable
corresponded author Avideh Maboudi Avideh48188@yahoo.com
What processes are involved for a request to access data/document
It does not take much time. It may take up to a week to send you an email right after we receive it
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