Comparison of the effect of scaling and root planing alone and scaling and root planing with curcumin-ginger mouthwash on IL-1b concentration in saliva
Design
randomized ,double blinded, parallel group
Settings and conduct
30 referrals to the periodontology department of Zanjan dental school in the year 1397 with moderate to severe chronic generalized periodontitis and probe depth> 4mm in at least 2 regions are selected to participate in the study.Full verbal explanation and written consent and health education is done.Patients are randomly divided into two groups (case and control) .Unstimulated saliva samples collected from patients. Then for all patients complete treatment includes scaling and root planing done.Patients in the study group will receive curcumin-ginger mouthwash and Patients in the control group will receive a placebo . patients will be asked to take 2 ml of mouthwash 2 times a day for 1 minute for 2 weeks after brushing.Two weeks after treatment of scaling non-stimulated saliva samples are collected again.Salivary IL_1B levels are compared at the start and end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients older than 30 years
2. Patients with moderate to severe chronic periodontitis and probe values> 4mm
3. Patients with at least 20 teeth in the mouth
No entry criteria:
1. History of Systemic Disease
2. Pregnant or lactating women
3. History of antibiotic prophylaxis in the 6 months before study or use of antibiotics in the last 3 months
4. Patients with oral breathing
5. Patients with orthodontic appliances or dental prosthodontics
6. Patients with harmful habits such as smoking
7. People allergic to turmeric or ginger
Intervention groups
The intervention consisted of curcumin-ginger mouthwash in the study group and placebo mouthwash in the control group
Main outcome variables
Change in salivary IL_1B level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180516039682N2
Registration date:2018-11-16, 1397/08/25
Registration timing:retrospective
Last update:2018-11-16, 1397/08/25
Update count:0
Registration date
2018-11-16, 1397/08/25
Registrant information
Name
Raheleh Akhavan rasoolzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8101
Email address
r.rasoolzadeh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-09-11, 1397/06/20
Actual recruitment start date
2018-05-23, 1397/03/02
Actual recruitment end date
2018-08-24, 1397/06/02
Trial completion date
2018-08-24, 1397/06/02
Scientific title
Evaluation of curcumin _ ginger mouth wash effect on salivary IL-1B levels in chronic periodontitis
Public title
Evaluation of curcumin _ ginger mouth wash effect on salivary IL-1B levels in chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients older than 30 years
Patients with chronic moderate to severe periodontitis and probing depth > 4mm
Patients with at least 20 teeth in the mouth
Exclusion criteria:
History of Systemic Disease
Pregnant or lactating women
History of antibiotic prophylaxis 6 months prior to study or use of antibiotics in the last 3 months
Patients with mouth breathing
Patients with orthodontic appliances or dental prosthodontics
Patients with harmful habits such as smoking
People allergic to turmeric or ginger
Age
From 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Unstimulated saliva sample
Actual sample size reached:
30
More than 1 sample in each individual
Actual sample size in each individual:
2
Unstimulated saliva sample
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization,Each patient was assigned one number. Then, using a random number table, each number was placed in one of the intervention group(curcumin- ginger mouthwash) or control group (placebo mouthwash).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were blinded to placebo or curcumin-ginger mouthwash. The outcome evaluator (immunologic kit checker) was blinded as well.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Central Station of Zanjan University of Medical Sciences-The Beginning of the Islamic Republic Boulevard -Azadi Square-Zanjan
City
zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.ZUMS.REC.1397.066
Health conditions studied
1
Description of health condition studied
generalized chronic periodontitis
ICD-10 code
K05.32
ICD-10 code description
Chronic periodontitis, generalized
Primary outcomes
1
Description
level of salivary IL-1b
Timepoint
Measurement of salivary IL-1b at the beginning of the study (before the intervention) and 14 days after the start of mouthwash use
Method of measurement
human IL-1b ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Scaling and root planning,curcumin -ginger mouthwash twice a day for 2week
Category
Treatment - Drugs
2
Description
Control group: Scaling and root planning placebo mouthwash twice aday for 2week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Dental School
Full name of responsible person
Rahele Akhavan Rasool Zadeh
Street address
13 Ave, Mahdavi Blvd, Shahrak Karmandan , Dentistry University
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8101
Email
R.rasoolzadeh@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Central Station of Zanjan University of Medical Sciences-The Beginning of the Islamic Republic Boulevard -Azadi Square-Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 4771
Email
Pr@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?