Survey of the effect of Chamomile and Misvak containing dentifrice on gingival indexes: Plaque index, Bleeding on probing, Pocket depth compared to Triclosan containing dentifrice in gingivitis patients.
Design
A single blinded; randomized; controlled clinical trial with parallel groups design of 15 patients; enrolled between October 2019 and December 2019; followed for 4 weeks
Settings and conduct
Sampling is carrying out in Periodontics department of Shiraz dental school. All the patients who met the inclusion criteria after obtaining a written consent will be examined and studying indexes will be recorded. They undergo scaling and oral hygiene education and divided by health care personnel into two groups randomly.The intervention group receive Chamomile and Miswak containing toothpaste and the control group received Triclosan containing toothpaste.Patients will be followed after 2 and 4 weeks and indexes will be recorded and analyzed. The main investigator and data analyzer are blinded in this study.
Participants/Inclusion and exclusion criteria
Gingivitis patient; No periodontitis and/or attachment loss; No periodontal pocket depth more than 3mm; Patient must be from 18 to 70 year old; At least 20 teeth without full crown restoration; Bleeding on probing index be at least 40%; No systemic disease like Diabetes or Cardiovascular disease; No intake of any particular medicine; Patients have not taken antibiotics in the past 6 months; Patients have not used mouthwash in the past 6 months; No smoking; No pregnancy
Intervention groups
In intervention group patients brush their teeth twice a day with soft tooth brushes and Chamomile and Miswak containing dentifrice for 4 weeks
In control group patients brush their teeth twice a day with soft toothbrushes and Triclosan containing dentifrice for 4 weeks.
Main outcome variables
plaque index; bleeding on probing index; pocket depth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190928044908N1
Registration date:2019-12-17, 1398/09/26
Registration timing:retrospective
Last update:2019-12-17, 1398/09/26
Update count:0
Registration date
2019-12-17, 1398/09/26
Registrant information
Name
Zahra Emami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 3193
Email address
zahra_emami63@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-06, 1398/07/14
Expected recruitment end date
2019-11-20, 1398/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Chamomile and Miswak containing dentifrice with Triclosan containing dentifrice in gingivitis patients
Public title
Effect of Chamomile and Miswak containing dentifrice on gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gingivitis patient
Patient must be from 18 to 70 year old
At least 20 teeth without full crown restoration
Bleeding on probing index must be at least 40%
No intake of any particular medicine
Patients have not taken antibiotics in the past 6 months
Patients have not used mouthwash in the past 6 months
No smoking
No pregnancy
Exclusion criteria:
Periodontitis and/or attachment loss
Periodontal pocket depth more than 3mm
Systemic disease like Diabetes or Cardiovascular disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups based on randomized block randomization method. A random individual has been extracted based on this method from Sealedenvelope.com . We have 2 groups and 15 participants in each group being equal in size. Allocation concealment is achieved through sealed envelopes. After the baseline questionnaire is completed, eligible participants are assigned to one of the 2 study groups by opening the envelopes as they entered the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a single blinded clinical trial. As the toothpaste is given to patients by healthcare providers, researcher does not know how individuals are assigned to the intervention and control groups. And data will be analyzed through coding. Principle investigator, data collectors and outcome assessors being one person is referred as researcher. As contents of both groups are listed on the toothpaste tube participants are not blinded.
Placebo
Not 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
Shiraz dental school, Ghasrodasht Ave.,Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Approval date
2019-09-08, 1398/06/17
Ethics committee reference number
IR.SUMS.DENTAL.REC.1398.110
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.10
ICD-10 code description
Chronic gingivitis, plaque induced
Primary outcomes
1
Description
The rate of periodontal pocket depth
Timepoint
Before intervention and after 2 and 4 weeks after intervention
Method of measurement
Periodontal probe
2
Description
The rate of bleeding on probing
Timepoint
Before intervention and 2, 4 weeks after intervention
Method of measurement
Periodontal probe
3
Description
The rate of dental plaque
Timepoint
Before intervention and 2, 4 weeks after intervention
Method of measurement
Disclosing agent
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Clean Key chamomile and Miswak containing dentifrice; made in Iran; Ahuradarou company.All toothpaste contents are listed on the toothpaste tube. Brush twice a day for four weeks using soft toothbrush and bass method as instructed by the researcher.
Category
Treatment - Drugs
2
Description
Control group: Vi-One gum protector Triclosan containing dentifrice; Made in Iran Rojin company..All toothpaste contents are listed on the toothpaste tube. Brush twice a day using soft toothbrush and bass method as instructed by the researcher
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz dental school
Full name of responsible person
Zahra Emami
Street address
Shiraz dental school, Ghasrodasht Ave.,Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
zahra_emami63@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz dental school,Ghasrodasht Ave.,Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@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
Zahra Emami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz dental school, Ghasrodasht Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
zahra_emami63@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Emami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz dental school, Ghasrdasht Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
zahra_emami63@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Emami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz dental school, Ghasrdasht Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
zahra_emami63@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available