Protocol summary
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Study aim
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Effectiveness of oral mouthwash containing persimmon extract in the treatment and reduction of symptoms of gingivitis patients
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Design
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In this clinical trial, 50 patients by simple randomization divided equally into two groups of drugs (4% persimmon extract), control (0.2% chlorhexidine).
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Settings and conduct
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50 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 is unaware of the fact that any mucous membranes received. mouthwash of persimmon is prepared by the pharmacological research center of Medicinal Plants of Mashhad University of Medical Sciences. Then, periodontist evaluated patients in the second week and one month later. Patients are urged not to use any other mouthwashes arbitrarily.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 1. gingivitis patients
2. All of these patients had at least 21 permanent teeth and no dental calculus
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Intervention groups
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For each patient, 10 ml of mouthwash two times a day (persimmon extract 4% or chlorhexidine 0.2%(Behsa, Iran)) for 2 weeks is administered. Persimmon extract is prepared by pharmacological research center of medical plants. The indices are evaluated in the second week and one month later by periodontist.
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Main outcome variables
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Gingivitis index, plaque index, pocket depth, Bleeding on probing
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190406043175N1
Registration date:
2019-07-16, 1398/04/25
Registration timing:
prospective
Last update:
2021-12-11, 1400/09/20
Update count:
1
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Registration date
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2019-07-16, 1398/04/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-09-22, 1398/06/31
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Expected recruitment end date
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2019-12-20, 1398/09/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Study of the effectiveness of persimmon extract on the treatment of patients with gingivitis
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Public title
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Persimmon extract in treatment of gingivitis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
gingivitis patients
All of these patients had at least 21 permanent teeth
no dental calculus
Exclusion criteria:
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this clinical trial, 50 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, 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 (4% persimmon extract), control (0.2% chlorhexidine).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-04-23, 1398/02/03
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1398.001
Health conditions studied
1
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Description of health condition studied
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Gingivitis
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ICD-10 code
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K05.1
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ICD-10 code description
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Chronic gingivitis
Primary outcomes
1
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Description
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Gingivitis index
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Timepoint
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At baseline, week 2 and week 4 of the trial.
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Method of measurement
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Examination by periodontist with periodontal Williams probe
2
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Description
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plaque index
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Timepoint
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At baseline, week 2 and week 4 of the trial.
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Method of measurement
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Examination by periodontist with periodontal Williams probe
3
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Description
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pocket depth
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Timepoint
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At baseline, week 2 and week 4 of the trial.
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Method of measurement
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Examination by periodontist with periodontal Williams probe
4
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Description
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Bleeding on probing
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Timepoint
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At baseline, week 2 and week 4 of the trial.
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Method of measurement
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Examination by periodontist with periodontal Williams probe
Intervention groups
1
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Description
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Intervention group: mouthwash containing 4% hydroalcoholic extract of persimmon .For each patient, 10 ml of persimmon extract two times a day for 2 weeks is administered. Persimmon extract is prepared by pharmacological research center of medical plants. The indices are evaluated in the second week and one month later by periodontist.
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Category
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Treatment - Drugs
2
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Description
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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 second week and one month later by periodontist.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Gingivitis index, plaque index, pocket depth, Bleeding on probing
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When the data will become available and for how long
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6 months after publication
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To whom data/document is available
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Medical universities
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Under which criteria data/document could be used
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Any evaluation and analysis must be done under the supervision of executor of the project:
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From where data/document is obtainable
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Sending email to executor of the project:
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What processes are involved for a request to access data/document
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Sending email to executor of the project and the response up to 1 week
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Comments
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