goal:
Comparison of the clinical effects of oral irrigation with Echinacea extract and Chlorhexidine as mouthwash on patients with chronic periodontitis.
Design
This is a double-blind controlled clinical trial study with 3 parallel groups using 3 different solutions.
Settings and conduct
Patients will be instructed to rinse for 30 seconds with 10 ml of undiluted mouth rinse once a day at night , for 28 days and to refrain from eating or drinking for 1 hour afterwards. Bass method will be taught to all patients. Also they will be instructed not to use any other dental hygiene products during the study period.
Information gathering:
The following procedure will be carried out for all patients,
1. Measuring Pocket depth
2. Bleeding index
3. Plaque index
4. Gingival index
These clinical parameters will be measured before scaling and root planning and four weeks later at the follow-up session. Clinical examination and data gathering will be performed by a single practitioner who is blind to the groups.
Complete scaling and root planning by cavitron and curette will be done for all the patients after the first measurements.
Participants/Inclusion and exclusion criteria
30 patients attending to the Department of Periodontology with chronic periodontitis.
Inclusion criteria:
1-Presence of minimum of 22 teeth.
2-Moderate or severe chronic periodontitis.
Exclusion criteria:
1-Patients with history of adverse reaction to chlorhexidine.
2-Antibiotic therapy during last 2 months.
3-Periodontal treatment during last 6 months.
4-Diabetes.
5-Pregnancy.
6-Lactation.
7-Tooth brushing more than 4 time.
8-Smoking
Intervention groups
Echinacea mouthwash will be given to the first group, CChlorhexidine will be given to the second group, and distilled water will be given to the third group.
Main outcome variables
Pocket depth
Bleeding index
Plaque index
Gingival index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190813044525N1
Registration date:2019-09-14, 1398/06/23
Registration timing:retrospective
Last update:2019-09-14, 1398/06/23
Update count:0
Registration date
2019-09-14, 1398/06/23
Registrant information
Name
Mohammad sadegh Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3646 6378
Email address
karamims@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-13, 1398/05/22
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical comparison between oral irrigation with Echinacea extract as mouthwash and chlorhexidine (0.12%) in chronic periodontitis patients.
Public title
Comparison between oral irrigation with Echinacea mouthwash and chlorhexidine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of minimum of 22 teeth.
Moderate or severe chronic periodontitis.
Exclusion criteria:
Patients with history of adverse reaction to chlorhexidine.
Antibiotic therapy during last 2 months.
Periodontal treatment during last 6 months.
Diabetes.
Pregnancy.
Lactation.
Tooth brushing more than 4 time per day.
Smoking
Patients are randomly assigned to groups a randomly by a person who is unaware to the stud by using the random numbers system.
Blinding (investigator's opinion)
Double blinded
Blinding description
same bottle will be use for all mouthwashes and a small color tag will be attach to botom of bottle. the bottle will be randomly given to patient by a third person who is blind to study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
In front of No 58 , Daneshvaran St, Chogiah St,
City
Shiraz
Province
Fars
Postal code
7194786554
Approval date
2019-08-11, 1398/05/20
Ethics committee reference number
IR.SUMS.DENTAl.REC.1398.59
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
1. Measuring Pocket depth (PD) .
Timepoint
At base line and after 28 day
Method of measurement
William probe
2
Description
.2. Bleeding index (BI)
Timepoint
At base line and after 28 day
Method of measurement
Lenox method by probe
3
Description
3. Plaque index (PI).
Timepoint
At base line and after 28 day
Method of measurement
modified O'Leary method by disclosing agents
4
Description
4. Gingival index (GI)
Timepoint
At base line and after 28 day
Method of measurement
Loe and Sillness method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Echinacea mouthwash (extract will be purchase from Zarband company and will be diluted with water to achieve .01% phenol as active compartment) will be given to the Intervention group.
Category
Treatment - Drugs
2
Description
Control group: chlorhexidine will be given to the positive control group
Category
Treatment - Drugs
3
Description
Control group: distilled water will be given to the negative control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontal department of Shiraz University of Medical Sciences dental school
Full name of responsible person
Hoda Sadat Banihashemi
Street address
Dental school,Ghas o dasht St .Shiraz.Iran
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3194
Fax
+98 71 3627 0325
Email
msk.sadegh@gmail.com
Web page address
http://dental.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
اندیشه تدبیر
Street address
Dental school,Ghas o dasht St .Shiraz.Iran
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3194
Fax
+98 71 3627 0325
Email
msk.sadegh@gmail.com
Web page address
http://dental.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Karami
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
In front of No 58 , Daneshvaran St, Chogiah St,
City
Shiraz
Province
Fars
Postal code
7194786554
Phone
+98 71 3646 6378
Fax
Email
karamims@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Karami
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
In front of No 58 , Daneshvaran St, Chogiah St,
City
Shiraz
Province
Fars
Postal code
7194786554
Phone
+98 71 3646 6378
Fax
Email
karamims@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Karami
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
In front of No 58 , Daneshvaran St, Chogiah St,
City
Shiraz
Province
Fars
Postal code
7194786554
Phone
+98 71 3646 6378
Fax
Email
karamims@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD