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Clinical and bacteriologic comparison of scaling & root planning by ultrasonic system with or without photodynamic therapy in patients with mild to moderate chronic periodontitis

Protocol summary

Summary
Aim: The aim of this randomized clinical trial is to compare the clinical and bacteriological effects of scaling & root planing (SRP) by ultrasonic system with or without photodynamic therapy (PDT) as an adjunctive treatment. Study Design: Interventional, randomized, single blind, unicenter, no placebo, parallel clinical trial. Study samples: Patients (20-60 years old), with mild to moderate chronic periodontitis, both sex. Inclusion Criteria: Patients with mild to moderate chronic periodontitis, pocket depth of 3-6 mm and bleeding on probing at least in 3 teeth. Exclusion criteria: Pregnancy, systemic disease, antibiotic therapy, malignancy, pockets over 6mm. The patients were selected based on inclusion and exclusion criteria. In a split-mouth design study, each patient randomly (by throwing a coin) received scaling and root planing in one site of the mouth and SRP with PDT in the other site. Microbiological samples were collected from all patients at baseline, 10, 42and 90 days after treatment and also clinical parameters including pocket depth, clinical attachment loss, bleeding on probing and papillary bleeding index were measured initially and 90 days after treatment. Sample size: Twenty samples in each group, totally forty. Intervention: Utilization of scaling and root planing with or without Photodynamic therapy. Intervention Duration: Ninety days. Primary Result: Bacterial colony counting of subgingival dental plaque, pocket depth, clinical attachment loss, bleeding on probing and papillary bleeding index.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013083112487N2
Registration date: 2013-11-07, 1392/08/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-11-07, 1392/08/16
Registrant information
Name
Shirin Amini
Name of organization / entity
Khorasgan Branch, Islamic Azad University, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4053
Email address
sh.amini@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and bacteriologic comparison of scaling & root planning by ultrasonic system with or without photodynamic therapy in patients with mild to moderate chronic periodontitis
Public title
Comparison of two scaling methods with or without photodynamic therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with mild to moderate periodontitis, pocket depth of 3-6 mm and bleeding on probing at least in 3 teeth. Exclusion criteria: Pregnancy, systemic disease, antibiotic therapy, malignancy, pockets over 6mm
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The teeth in each patient were randomly selected via throwing the coin to treat by one of the treatment methods.Blindness: All the variables were measured and microbial sampling was carried out by another examiner who was blind to the selected treatment modalities for each tooth.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Khorasgan Branch, Islamic Azad University
Street address
Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavaniyeh street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Postal code
81595158
Approval date
2012-04-14, 1391/01/26
Ethics committee reference number
07405/D/910303

Health conditions studied

1

Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Periodontitis:simplex

Primary outcomes

1

Description
count of anaerobe and aerobe bacteria in subgingival plaque
Timepoint
at baseline and 10, 42 and 90 days after intervention
Method of measurement
dilution and culture of bacterial samples in conventional and riched solid blood agar and visual colony counting

2

Description
pocket depth
Timepoint
at baseline and 90 days after intervention
Method of measurement
measuring of pocket depth in mm by a Williams periodontal probe (Hu-Friedy, Chicago, IL, US)

3

Description
clinical attachment loss
Timepoint
at baseline and 90 days after intervention
Method of measurement
Measuring of clinical attachment loss in mm by a Williams periodontal probe (Hu-Friedy, Chicago, IL, US)

4

Description
Bleeding on probing
Timepoint
at baseline and 90 days after intervention
Method of measurement
evaluation of bleeding intensity by Bleeding Index

5

Description
papillary bleeding index
Timepoint
at baseline and 90 days after intervention
Method of measurement
evaluation of bleeding score by Papillary Bleeding Index

Secondary outcomes

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Intervention groups

1

Description
scaling of selected teeth in one site of the mouth for at least one min by ultrasonic device (Faraz Dentine Co, Iran)
Category
Treatment - Devices

2

Description
Scaling of selected teeth in another area of the mouth for at least 1 min and then injection of photosensitizer Toluidine blue specific for Fotosan system with special syringe of Fotosan kit that is 0.1 ml and finally irradiation of red light in 630 wavelength from LED source of Fotosan device( CMS Dental Co, Germany) for 10 seconds by special periotip
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Periodontology, Dental School,Khorasgan Branch, Islamic Azad University and Abolabbas
Full name of responsible person
Street address
Dental School, Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan, Iran and Jey Street ,Khorasgan Square,Abolabbas Clinic, Isfahan,Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Vice- Chancellor of Islamic Azad University Khorasgan Branch
Full name of responsible person
Esfahanian, Vahid
Street address
Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice- Chancellor of Islamic Azad University Khorasgan Branch
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
Dental School, KhorasganBranch, Islamic Azad University
Full name of responsible person
Amini, Shirin
Position
Assistant Professor/ DDS, MSc
Other areas of specialty/work
Street address
Dental School, Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Postal code
81595158
Phone
+98 31 1535 4053
Fax
Email
Sh.amini@khuisf.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental School, Khorasgan Branch, Islamic Azad University
Full name of responsible person
Amini, Shirin
Position
Assistant Professor/ DDS, MSc
Other areas of specialty/work
Street address
Dental School, KhorasganBranch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Postal code
81595158
Phone
+98 31 1535 4053
Fax
Email
Sh.amini@khuisf.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dental School, Khorasgan Branch, Islamic Azad University
Full name of responsible person
Shirani Shiva
Position
Dental Student
Other areas of specialty/work
Street address
Dental School, Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Postal code
81595158
Phone
+98 31 1535 4053
Fax
Email
star6882e@yahoo.com
Web page address

Sharing plan

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