Effectiveness of toothpaste containing persimmon 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 (persimmon extract toothpaste), control toothpaste.
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 toothpaste. toothpaste of persimmon is prepared by the pharmacological research center of Medicinal Plants of Mashhad University of Medical Sciences. Then, periodontist evaluated patients one month later. Patients are urged not to use any other toothpaste arbitrarily.
Participants/Inclusion and exclusion criteria
Gingivitis patients
Intervention groups
For each patient, toothpaste two times a day (persimmon extract or control) for 4 weeks is administered. Persimmon extract is prepared by pharmacological research center of medical plants. The indices are evaluated in one month later by periodontist.
Main outcome variables
Gingivitis index, Plaque index, Pocket depth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190406043175N7
Registration date:2022-07-27, 1401/05/05
Registration timing:prospective
Last update:2022-07-27, 1401/05/05
Update count:0
Registration date
2022-07-27, 1401/05/05
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
2022-09-29, 1401/07/07
Expected recruitment end date
2024-09-28, 1403/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of toothpaste containing persimmon extract in the treatment of patients with gingivitis
Public title
Persimmon extract toothpaste in treatment of gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gingivitis Patients
Exclusion criteria:
Pregnant or lactating women
Allergic to oral hygiene products
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
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 gingivitis. The informed consent was completed and included the study. By using simple randomization method, a number of 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 (toothpaste containing persimmon extract), control toothpaste.
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 toothpaste is given to each group.Few drops of standard edible brown color will be added to the toothpaste of the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of dentistry school, Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1400.150
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, and week 4 of the trial.
Method of measurement
Examination by periodontist with periodontal Williams probe
2
Description
Plaque index
Timepoint
At baseline, and week 4 of the trial.
Method of measurement
Examination by periodontist with periodontal Williams probe
3
Description
Pocket depth
Timepoint
At baseline, 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: toothpaste containing extract of persimmon. For each patient, toothpaste of persimmon extract two times a day for 4 weeks is administered. Persimmon extract is prepared by pharmacological research center of medical plants. The indices are evaluated in one month later by periodontist.
Category
Treatment - Drugs
2
Description
Control group: Control toothpaste two times a day for 4 weeks is administered. The indices are evaluated in one month later by periodontist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics affiliated to Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Forouzanfar
Street address
Mashhad University of Medical Science, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
forouzanfarf@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Deputy of Research and Technology, Ghorashi Building, next to Hoveyzeh Cinema, University Street
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
Fatemeh Forouzanfar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Mashhad University of Medical Sciences, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2538
Email
forouzanfarf@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Forouzanfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mashhad University of Medical Sciences, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2538
Email
forouzanfarf@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Forouzanfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mashhad University of Medical Sciences, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2538
Email
forouzanfarf@mums.ac.ir
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