Protocol summary

Study aim
Evaluation of root surface roughness produced by hand instruments and ultrasonic scalers: an in vivo study
Design
In this study 35 single roots (28 of them with periodontal problems) which had inclusion criteria are selected. Teeth are divided in to five groups ( hand instrument, low power ultrasonic, medium power ultrasonic, high power ultrasonic and control groups).There are seven teeth in each groups which scaling and rootplaning are done with different instruments and surface roughness is assessed with AFM device.
Settings and conduct
Scaling and rootplanig is doing on 28 teeth with different instrument in In vivo condition and root surface roughness is assessed by AFM device .this study is doing in Shahid Sadoughi Faculty of Dentistry Yazd
Participants/Inclusion and exclusion criteria
Inclusion criteria: single root teeth, at least 70% bone loss and mobility grade II, without SRP history, without root surface with decay exclusion criteria: fracture during tooth extraction
Intervention groups
group1: scaling and rootplaning with gracey curettes No 1/2, 3/4, 5/6 group 2: scaling and rootplaning with a low power ultrasonic device group 3: scaling and rootplaning with a moderate power ultrasonic device group 4: scaling and rootplaning with a high power ultrasonic device group 5: control
Main outcome variables
root surface roughness(Rq) of each group

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171015036782N3
Registration date: 2018-03-18, 1396/12/27
Registration timing: retrospective

Last update: 2018-03-18, 1396/12/27
Update count: 0
Registration date
2018-03-18, 1396/12/27
Registrant information
Name
farzane vaziri
Name of organization / entity
Shahid sadoughi dental university
Country
Iran (Islamic Republic of)
Phone
+98 35 3620 4764
Email address
f.vaziri@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-11, 1396/04/20
Expected recruitment end date
2017-08-11, 1396/05/20
Actual recruitment start date
2017-10-02, 1396/07/10
Actual recruitment end date
2017-11-01, 1396/08/10
Trial completion date
empty
Scientific title
Evaluation of root surface roughness produced by hand instruments and ultrasonic scalers in single root teeth: an in vivo study
Public title
Evaluation of root surface roughness produced by hand instruments and ultrasonic scalers: an in vivo study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
single root teeth at least 70% bone loss and mobility grade II without SRP history without root surface with decay
Exclusion criteria:
fracture during tooth extraction
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 35
Actual sample size reached: 35
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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 yazd University of Medical Sciences
Street address
No.304, A6, baharan apartment, bahar Ave, daneshgah Blv
City
yazd
Province
Yazd
Postal code
8915839985
Approval date
2017-04-10, 1396/01/21
Ethics committee reference number
IR.SSU.REC.1396.2

Health conditions studied

1

Description of health condition studied
root surface roughness
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
root surface roughness
Timepoint
In study has no timepoint
Method of measurement
Atomic force microscope

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: scaling and rootplaning with gracey curettes No 1/2, 3/4, 5/6 (Hu-Friedy)
Category
Treatment - Devices

2

Description
Intervention group: scaling and rootplaning with a low power ultrasonic device (woodpecker)
Category
Treatment - Devices

3

Description
Intervention group: scaling and rootplaning with a moderate power ultrasonic device (woodpecker)
Category
Treatment - Devices

4

Description
Intervention group: scaling and rootplaning with a high power ultrasonic device (woodpecker)
Category
Treatment - Devices

5

Description
Control group: No intervention
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
shahid sadoughi University of Medical Sciences
Full name of responsible person
Seyed Mohamad Arab Farashahi
Street address
Shahid Sadoughi Faculty of Dentistry Yazd, Emam Reza square
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
sma.farashahi_69@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alireza Danesh Kazemi
Street address
Shahid Sadoughi Faculty of Dentistry Yazd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
sma.farashahi_69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
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
Yazd University of Medical Sciences
Full name of responsible person
Seyed Mohamad Arab Farashahi
Position
post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.304, A6, baharan apartment, bahar Ave, daneshgah Blv
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 38269243
Email
f.vaziri@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Mohamad Arab Farashahi
Position
post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.304, A6, baharan apartment, bahar Ave, daneshgah Blv
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3826 9243
Email
sma.farashahi_69@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Mohamad Arab Farashahi
Position
post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.304, A6, baharan apartment, bahar Ave, daneshgah Blv
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3826 9243
Email
sma.farashahi_69@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The whole data is shared
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Email, call
From where data/document is obtainable
09133735190 Seyed Mohammad Arab Farashahi sma.farashahi_69@yahoo.com
What processes are involved for a request to access data/document
After sending the Email, the data will be transmitted
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