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Evaluation effect of mucoadhesive nigella sativa in the treatment of chronic periodontitis

Protocol summary

Summary
The purpose of this study is to compare the effectiveness of muco-adhesive Nigella Sativa extract with muco-adhesive Thymoquinone as an adjunctive topical treatment medicine following scaling and root planning (SRP), and to compare them with the outcomes of treating chronic periodontitis by performing SRP only. This is a randomized, triple-blind, placebo controlled study. Samples are chosen from patients suffering from chronic periodontitis who referred to Kermanshah Faculty of Dentistry. Inclusion criteria: patient free from systemic illness; patient who had not taken periodontal therapy in the past 3 month Exlusion criteria: dissatisfaction and inability to comply with the follow-up visit requirments; history of systemic illness; received antioxidants like vitamin C and E or β-Carotene; pregnant. In each patient after scaling and root planing, muco-adhesive Nigella Sativa gel is injected in one site, muco-adhesive Thymoquinone gel is injected in another site and on the third site placebo is injected. Clinical parameters to be considered including plaque index, gingival index, pocket depth, clinical attachment loss, and bleeding index are evaluated pre-treatment and in 8, 15, 30, and 90 days post-treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016021826637N1
Registration date: 2017-02-15, 1395/11/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-15, 1395/11/27
Registrant information
Name
Seyed Mohamad Saleh Yassini
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3845 2545
Email address
sms.yassini@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-08-10, 1395/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of mucoadhesive nigella sativa in the treatment of chronic periodontitis
Public title
Effect of nigella sativa in the treatment of chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient free from systemic illness; patient who had not taken periodontal therapy in the past 3 month Exlusion criteria: dissatisfaction and inability to comply with the follow-up visit requirments; history of systemic illness; received antioxidants like vitamin C and E or β-Carotene; pregnant
Age
No age limit
Gender
Both
Phase
2
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
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti blvd, Kermanshah
City
Kermanshah
Postal code
Approval date
2016-06-08, 1395/03/19
Ethics committee reference number
KUMS.REC.1395.176

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
probing pocket depth
Timepoint
Baseline, one week, two weeks, one and three months after the intervention
Method of measurement
Williams Periodontal Probe

2

Description
Clinical attachment loss
Timepoint
Baseline, one week, two weeks, one and three months after the intervention
Method of measurement
Williams Periodontal Probe

3

Description
plaque index
Timepoint
Baseline, one week, two weeks, one and three months after the intervention
Method of measurement
plaque index Silness & Loe

4

Description
Gingival Index
Timepoint
Baseline, one week, two weeks, one and three months after the intervention
Method of measurement
Observed

5

Description
Bleeding Index
Timepoint
Baseline, one week, two weeks, one and three months after the intervention
Method of measurement
Observed\Bleeding Index Muhlemann

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:SRP with Mucoadhesive Locally Delivery Nigella Sativa extract 0.2%
Category
Treatment - Drugs

2

Description
Intervention group:SRP with Mucoadhesive Locally Delivery Thymoquinone 0.02%
Category
Treatment - Drugs

3

Description
Control group:SRP with placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Periodontology, Kermanshah faculty of dentistry
Full name of responsible person
Street address
City
kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ethics committee of Kermanshah University of Medical Sciences
Full name of responsible person
Kurosh Hamzehee
Street address
Ethics Committe of Kermanshah University of Medical Sceinces, Shahidbeheshti Blvd, Kermanshah
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
Seyed Mohamad Saleh Yassini
Position
Dental student
Other areas of specialty/work
Street address
Opposite of the post office, Shora st, Dr Shariati st, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3722 2400
Fax
Email
sms.yassini@kums.ac.irsmsaleh0089@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah Dentistry School
Full name of responsible person
Dr Narges Ziaei
Position
Phd
Other areas of specialty/work
Street address
Opposite of the post office, Shora st, Dr Shariati st, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3729 0222
Fax
Email
nargess.ziaei@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah Dentistry School
Full name of responsible person
Seyed Mohamad Saleh Yassini
Position
Dental student
Other areas of specialty/work
Street address
Opposite of the post office, Shora st, Dr Shariati st
City
kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Fax
Email
sms.yassini@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
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