Protocol summary

Summary
To determine the effects of topical curcumin Nano gel and chlorhexidine Mouthwash on gingival inflammation in chronic gingivitis on 40 patients, both men and women and has no age limit. In this clinical trial, double-blind, phase 3 trials are study. Inclusion criteria: Having public health, without the need for antibiotic prophylaxis, non-pregnant, non-use of anti-inflammatory substances within six weeks ago and at the time of check Output criteria: Systemic diseases, allergy to any drug in medical history, especially turmeric, periodontitis Participants were randomly divided into two groups of 20 persons (20 tests, 20 people controls) After Scaling and root planning of test group, we measure the index of GI, BOP and PI and then volunteers receive topical curcumin Nano gel 1% and they use it twice a day for 2 weeks (For 1 minute put gel on the gums) Then two weeks later and one month later the indicators PI, GI and BOP were measured. After scaling and root planning of control group, we measure the index of GI, BOP and PI and then receiving 0.2% chlorhexidine should be used twice a day for two weeks.) Each time, 30 seconds in the mouth and then spit out turn (Then two weeks later and one month later the indicators PI, GI and BOP were measured. At the beginning of the study, Scaling and root planning is done for all volunteers. (In order to simulate the conditions volunteers) A health kit is the same as that of gel or mouthwash test and it is said that they do not use any other products during the study. Executive is not aware of volunteers Health kits. Volunteers are not aware that they are in the test group or control. Health Kit contents will be determined at the end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012832231N1
Registration date: 2017-02-07, 1395/11/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-07, 1395/11/19
Registrant information
Name
Aynaz Alidadiani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3806 7224
Email address
alidadiania901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-11-10, 1395/08/20
Expected recruitment end date
2016-12-10, 1395/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determine and compare the effects of topical curcumin nanoparticles and chlorhexidine gel on gingival inflammation in chronic gingivitis
Public title
Determine and compare the effects of topical curcumin nanoparticles and chlorhexidine gel on gingival inflammation in chronic gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:A public health; Being without antibiotic prophylaxis; Non-use of anti-inflammatory substances within six weeks ago and at the time of check; Do not use medications such as antihistamines, antidepressants or analgesics within six weeks ago at the time of review; none pregnant Exclusion criteria:Pregnant or lactating mothers; Systemic Disease; Allergy to any drug in medical history, especially of turmeric periodontitis
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad university of medical science
Street address
College of Dentistry,opposite Mellat Park, beginning in Vakil Abad Boulevard, Mashhad
City
Mashhad
Postal code
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
IR.mums.sd.REC.1394.162

Health conditions studied

1

Description of health condition studied
gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis

Primary outcomes

1

Description
Plaque index
Timepoint
After SRP , 2 weeks later and a month later
Method of measurement
Eye determining PI

2

Description
GBI
Timepoint
After SRP , 2 weeks later and a month later
Method of measurement
Eye determining GBI

3

Description
BOP
Timepoint
After SRP , 2 weeks later and a month later
Method of measurement
Eye determining BOP by Periodontal Probe

Secondary outcomes

empty

Intervention groups

1

Description
Nano Gel topical curcumin At a dose of 1% twice a day for 1 minute
Category
Treatment - Drugs

2

Description
Chlorhexidine 0.2% Twice daily mouthwash for 30 seconds
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Dr Kazem Fatemi
Street address
College of Dentistry,opposite Mellat Park, beginning in Vakil Abad Boulevard, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Kazem Fatemi
Street address
College of Dentistry, opposite Mellat Park, beginning in Vakil Abad Boulevard, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
DR Majid Reza Mokhtari
Street address
College of Dentistry, opposite Mellat Park, beginning in Vakil Abad Boulevard, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Kazem Fatemi
Position
Periodontist/Associate Prof
Other areas of specialty/work
Street address
College of Dentistry, opposite Mellat Park, beginning in Vakil Abad Boulevard, Mashhad رر؛
City
Mashhad
Postal code
Phone
+98 51 3806 7224
Fax
Email
fatemik@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Kazem Fatemi
Position
Periodontist/Associate Prof
Other areas of specialty/work
Street address
College of Dentistry, opposite Mellat Park, beginning in Vakil Abad Boulevard, Mashhad رر؛
City
Mashhad
Postal code
Phone
+98 51 3806 7224
Fax
Email
fatemik@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Kazem Fatemi
Position
Periodontist/Associate Prof
Other areas of specialty/work
Street address
College of Dentistry, opposite Mellat Park, beginning in Vakil Abad Boulevard, Mashhad
City
Mashhad
Postal code
9177948959
Phone
+98 51 3806 7224
Fax
+98 51 3882 9500
Email
fatemik@mums.ac.ir
Web page address
http://www.mums.ac.ir

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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