Protocol summary

Summary
Aim: Comparison of immediate effect of root instrumentation with curettes and ultrasonic scalers on Clinical Attachment Level in patients referring to Department of Periodontics, Dental Branch, Islamic Azad University of Tehran Design: Single blinded randomized clinical trial Setting: The eligible patients with moderate chronic periodontitis, presenting probing depths of 3.5-6.5 mm on two anterior teeth, upper or lower , will be selected and teeth will be randomly assigned to two different treatment groups of ultrasonic scaler and Gracey curettes. The selected teeth will be probed with a pressure sensitive probe, guided by an occlusal stent and subjected to scaling and root planing and immediately following instrumentation , teeth probed again. Inclusion criteria: Existing a pair of bilateral anterior teeth in maxilla and mandible Exclusion criteria: Usage of the drug which makes intervention with tissue metabolic reaction such as: Verapamil, Nifedipine, Phenytoin; Needs to antibiotic prophylaxis in order to do probing and it’s related treatments Intervention (a): Subgingival instrumentation will be done with an ultrasonic scaler. Intervention (b): Subgingival instrumentation will be done with an Gracey curettes Primary outcome: Clinical Attachment Level based on distance from pocket base to occlusal edge Secondary outcome: Trauma from Instrumentation based on difference between Relative Attachment Level immediately before and after instrumentation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013080314255N1
Registration date: 2014-02-17, 1392/11/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-17, 1392/11/28
Registrant information
Name
Fatemeh Sarlati
Name of organization / entity
Dental Branch, Islamic Azad University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
fa_sarlati@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of immediate effect of root instrumentation with curettes and ultrasonic scalers on Clinical Attachment Level
Public title
Comparison of subgingival scaling effect with curettes and ultrasonic scalers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Existing a pair of bilateral anterior teeth in maxilla and mandible Exclusion criteria: Usage of the drug which makes intervention with tissue metabolic reaction such as: Verapamil, Nifedipine, Phenytoin; Needs to antibiotic prophylaxis in order to do probing and it’s related treatments
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 15
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
Ethical Committee of Dental Branch, Islamic Azad University of Tehran
Street address
Postcode: 19585175, Periodontics Department, Dental Branch, Islamic Azad University,Tenth Neyestan, Pasdaran,Tehran, Iran
City
Tehran
Postal code
19585175
Approval date
2006-11-14, 1385/08/23
Ethics committee reference number
11082

Health conditions studied

1

Description of health condition studied
Periodontal Attachment loss
ICD-10 code
K05.3
ICD-10 code description
Chronic Priodontitis

Primary outcomes

1

Description
Clinical attachment level
Timepoint
Immidiately Before and after treament
Method of measurement
Quantitative measurement of distance from pocket base to edge of occlusal stent in milimeters

Secondary outcomes

1

Description
Trauma from Instrumentation
Timepoint
Immediately Before and After Treatment
Method of measurement
Based on difference between Relative Attachment Level

Intervention groups

1

Description
Ultrasonic scaling Group : That subgingival instrumentation will be done with an Hu-Friedy ultrasonic scaler
Category
Treatment - Devices

2

Description
Curette Scaling Group: That subgingival instrumentation will be done with an Hu-Friedy 5/6 Gracey curettes
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental Branch, Islamic Azad Univercity of Tehran
Full name of responsible person
Dr Fatemeh Sarlati
Street address
Postcode: 19585175, Periodontics Department, Dental Branch, Islamic Azad University,Tenth Neyestan, Pasdaran,Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Investigator
Street address
Postcode:853, Endodontics Department, School of Dentistry,Ganj Afrooz Street, Babol, Iran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Babol University of Medical Sciences
Full name of responsible person
Dr Narges Simdar
Position
Resident
Other areas of specialty/work
Street address
Postcode:853, Endodontics Department, School of Dentistry,Ganj Afrooz Street, Babol, Iran
City
Babol
Postal code
853
Phone
+98 11122914089
Fax
+98 11 1229 1093
Email
n.simdar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental Branch, Islamic Azad University of Tehran
Full name of responsible person
Dr Fatemeh Sarlati
Position
Associated professor/ Periodontist
Other areas of specialty/work
Street address
Postcode: 19585175, Periodontics Department, Dental Branch, Islamic Azad University,Tenth Neyestan, Pasdaran,Tehran, Iran
City
Tehran
Postal code
19585175
Phone
+98 21225645713
Fax
+98 21 2256 4677
Email
fa_sarlati@denatliau.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Narges Simdar
Position
Resident
Other areas of specialty/work
Street address
Postcode:853, Endodontics Department, School of Dentistry, Ganj Afrooz Street, Babol, Iran
City
Babol
Postal code
853
Phone
+98 11 1229 1408
Fax
+98 11 1229 1093
Email
n.simdar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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