Effectiveness of oral mouthwash containing Tamarix gallica extract in the treatment and reduction of symptoms of gingivitis patients
Design
In this clinical trial, 56 patients by simple randomization divided equally into two groups of drugs (4%Tamarix gallica extract), control (0.2% chlorhexidine).
Settings and conduct
56 patients with gingivitis from the outpatients referred to dental school, Mashhad University of Medical Sciences, Mashhad, Iran, were randomly assigned to two groups of and were equally divided. Patients are given two groups of non-labeled mouthwashes, and the periodontist
The periodontist is also unaware of what mouthwash each patient has received. mouthwash of Tamarix gallica is prepared by the pharmacological research center of Medicinal Plants of Mashhad University of Medical Sciences. Then, periodontist evaluated patients in the first week and one month later. Patients are urged not to use any other mouthwashes arbitrarily.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. gingivitis patients 2. All of these patients had at least 20 permanent teeth
Exclusion criteria: 1. Need to prescribe antibiotics to treat gingivitis 2. Taking anti-inflammatory drugs during the study period. 3. Taking anticoagulants drugs during the study period. 4. Pregnancy and breastfeeding
Intervention groups
For each patient, 10 ml of mouthwash two times a day (Tamarix gallica extract 4% or chlorhexidine 0.2%(Behsa, Iran)) for 2 weeks is administered. Tamarix gallica extract is prepared by pharmacological research center of medical plants. The indices are evaluated in the first week and one month later by periodontist.
Main outcome variables
Gingivitis index, plaque index, pocket depth, Bleeding on probing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190406043175N4
Registration date:2021-06-23, 1400/04/02
Registration timing:prospective
Last update:2021-06-23, 1400/04/02
Update count:0
Registration date
2021-06-23, 1400/04/02
Registrant information
Name
fatemeh forouzanfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3761 7318
Email address
forouzanfarf@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-21, 1400/05/30
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of Tamarix gallica on the treatment of patients with gingivitis
Public title
Tamarix gallica extract in treatment of gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gingivitis patients
All of these patients had at least 20 permanent teeth
Exclusion criteria:
Need to prescribe antibiotics to treat gingivitis
Taking anti-inflammatory drugs during the study period
Taking anticoagulants drugs during the study period
Pregnancy and breastfeeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial, 56 patients were assigned to the dental faculty with mild to moderate gingivitis. The informed consent was completed and included the study. By using simple randomization method, 28 cards are selected by the researcher as the first group and the same number of cards for the next group. Then, by merging the cards together (by adding the cards), a card is taken out and its allocation is recorded, and that card is returned to the other cards by merging the cards together (by adding the cards). The cards then merge again and another card will have picked up. This process continues to reach a random sequence according to sample size. The patients divided equally into two groups of drugs (4% Tamarix gallica extract), control (0.2% chlorhexidine).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study mouthwash is given to patients non-labeled, and the periodontist is unaware of which mouthwash is given to each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Faculty of medicine, University campus, Azadi square, Mashhad university of Medical sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.488
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
Gingivitis index
Timepoint
At baseline, week 1 and week 4 of the trial
Method of measurement
Examination by periodontist with periodontal Williams probe
2
Description
Plaque index
Timepoint
At baseline, week 1 and week 4 of the trial.
Method of measurement
Examination by periodontist with periodontal Williams probe
3
Description
Pocket depth
Timepoint
At baseline, week 1 and week 4 of the trial.
Method of measurement
Examination by periodontist with periodontal Williams probe
4
Description
Bleeding on probing
Timepoint
At baseline, week 1 and week 4 of the trial.
Method of measurement
Examination by periodontist with periodontal Williams probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: mouthwash containing 4% hydroalcoholic extract of Tamarix gallica .For each patient, 10 ml of Tamarix gallica extract two times a day for 2 weeks is administered. Tamarix gallica extract is prepared by pharmacological research center of medical plants. The indices are evaluated in the first week and one month later by periodontist.
Category
Treatment - Drugs
2
Description
Control group: Chlorheddine 0.2% produced by Behsa Iran Co.For each patient, 10 ml of mouthwash two times a day for 2 weeks is administered. The indices are evaluated in the first week and one month later by periodontist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Hassan Rakhshandeh
Street address
Mashhad dental school, University Campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
Rakhshandehh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Deputy of Research and Technology,next to. Hoveyzeh Cinema, Ghorashi Building,Daneshgah. Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Ramresearch@mums.ac.ir
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
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
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Rakhshandeh
Position
Assistant professor, Mashhad University of medical sciences
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacological Research Center of Medicinal Plants,. Faculty of Medicine, Pardis campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3882 8566
Email
rakhshandehh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Rakhshandeh
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacological Research Center of Medicinal Plants,. Faculty of Medicine, Pardis campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3882 8566
Email
Rakhshandehh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Rakhshandeh
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacological Research Center of Medicinal Plants,. Faculty of Medicine, Pardis campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3882 8566
Email
Rakhshandehh@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Gingivitis index, plaque index, pocket depth, Bleeding on probing
When the data will become available and for how long
6 months after publication
To whom data/document is available
Medical universities
Under which criteria data/document could be used
Any evaluation and analysis must be done under the supervision of executor of the project
From where data/document is obtainable
Sending email to executor of the project
What processes are involved for a request to access data/document
Sending email to executor of the project and the response up to 1 week