Protocol summary

Summary
In this study with the purpose of studying the efficacy of Kermanshahi oil gel in treatment of chronic periodontitis compared with Chlorehexidine gel , 20 patients with chronic periodontitis with at least three sites having probing depth of 5 to 7 mm ,were selected.in early phase , periodontal parameters including plaque index , pocket depth , clinical attachment loss , gingival index were measured. These indices were assessed within the recall period in two weeks after scaling and root planning. Following, chlorhexidine gel was injected in one site, kermanshahi oil gel was injected in another site and on the third site SRP was just performed. Periodontal packs were placed on the sites of injection to ensure that gels were remained until the following recall. The indices were remeasured within 30 and 45 days

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015122225649N1
Registration date: 2016-03-04, 1394/12/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-04, 1394/12/14
Registrant information
Name
Masoome Eivazi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3822 8397
Email address
m.eivazi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of Kermanshahi oil gel in treatment of chronic periodontitis
Public title
Kermanshahi oil effect in treatment of gingival inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Good general health with no history of any systemic disease, No history of periodontal treatment during the last six month, No history of antibiotic therapy during 3 to 4 weeks before the study begins, No history of using mouthwash during the last 2 month;Exclusion criteria: Smokers , Pregnant or lactating females
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Dentistry school of Kermanshah University of Medical Sciences
Street address
Opposite of the Post ofiice , Shora street , Shariati street
City
kermanshah
Postal code
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
KUMS.REC.1394.234

Health conditions studied

1

Description of health condition studied
chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
chronic periodontitis

Primary outcomes

1

Description
pocket depth
Timepoint
screen day,two weeks after intervention,thirty days after intervention,forty five days after intervention
Method of measurement
measuring the distance of pocket base to the gingval margin with periodontal probe

2

Description
CAL
Timepoint
screen day,two weeks after intervention,thirty days after intervention,forty five days after intervention
Method of measurement
measuring the distance of base of the pocket from CEJ

3

Description
gingival index
Timepoint
screen day,two weeks after intervention,thirty days after intervention,forty five days after intervention
Method of measurement
to evaluate conditions before and after phase one or surgical treatment

4

Description
plaque index
Timepoint
screen day,two weeks after intervention,thirty days after intervention,forty five days after intervention
Method of measurement
colored surfaces of tooth by disclosing agent

Secondary outcomes

empty

Intervention groups

1

Description
intervention group 1: CHX gel ,0.5cc
Category
Treatment - Drugs

2

Description
intervention group 2 kermanshahi oil gel ,0.5 cc
Category
Treatment - Drugs

3

Description
control group scaling and root planning
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
periodontics,dentistry school of kermanshah university of medical sciences
Full name of responsible person
Masoome Eivazi
Street address
Dentistry school , Shora street, Shariati street
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ethics committee of Kermanshah University of Medical Sciences
Full name of responsible person
Kourosh Hamzeei
Street address
Ethics Committe of Kermanshah University of Medical Sceinces,Shahidbeheshti Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ethics committee of Kermanshah 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
Kermanshah Dentistry School
Full name of responsible person
Dr.Masoome Eivazi
Position
assistant professor
Other areas of specialty/work
Street address
Opossite the post office , Shora street , Shariati street
City
Kermanshah
Postal code
Phone
+98 83 3722 2400
Fax
Email
m.eivazi@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah Dentistry School
Full name of responsible person
Dr.Masoome Eivazi
Position
Phd
Other areas of specialty/work
Street address
Shora street , Shariati street
City
Kermanshah
Postal code
Phone
+98 83 3722 2400
Fax
Email
m.eivazi@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah Dentistry School
Full name of responsible person
Dr.Masoome Eivazi
Position
ََAssistant Professor
Other areas of specialty/work
Street address
Opossite the post office , Shora street , Shariati street
City
Kermanshah
Postal code
Phone
+98 83 3722 2400
Fax
Email
m.eivazi@kums.ac.ir
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
Loading...