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IRCT20190406043175N13 IRCT 2025-07-17 Mashhad University of Medical Sciences Persimmon and Nigella sativa toothpaste for treating gingivitis Investigating the effectiveness of toothpaste containing persimmon and Nigella sativa in the treatment of patients with gingivitis 2025-09-22 anticipated 56 Recruiting https://irct.ir/trial/84737 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial, 56 patients with gingivitis were selected from outpatients at the Mashhad School of Dentistry. After obtaining informed consent, the participants were randomly assigned into two groups using simple randomization through a card method. In this method, an equal number of cards labeled with the names of the two study groups (the group receiving Nigella sativa and persimmon extract, and the control group using regular toothpaste) were prepared. The cards were thoroughly mixed, and one card was randomly drawn for each participant. After recording the group corresponding to the selected card, the card was returned to the pool. This process was repeated until all participants were randomly allocated, Blinding description: In this double-blind study, toothpaste will be provided to participants in both groups in unlabeled and visually identical tubes. To ensure similarity in color and prevent participants from distinguishing between the intervention group (receiving toothpaste containing Nigella sativa and persimmon extract) and the control group, a specific amount of edible brown coloring will be added to the control toothpaste to match the color of the herbal toothpaste. Additionally, efforts will be made to match the control toothpaste with the herbal toothpaste in terms of consistency (viscosity), taste, and packaging. Therefore, there will be no noticeable difference between the two toothpastes in terms of color, appearance, taste, method of use, or packaging, and participant-level blinding will be maintained. 2 Gingivitis. Intervention 1: Intervention group: Toothpaste containing extract of persimmon and nigella sativa. For each patient, toothpaste of persimmon extract two times a day for 4 weeks is administered. Herbal extract is prepared by pharmacological research center of medical plants. The indices are evaluated in one month later by periodontist. Intervention 2: Control group: Regular toothpaste two times a day for 4 weeks is administered. The indices are evaluated in one month later by periodontist. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information available.
public Fatemeh Forouzanfar
Mashhad University of Medical Sciences, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2538 forouzanfarf@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Forouzanfar
Mashhad University of Medical Sciences, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2538 forouzanfarf@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Gingivitis patients 18 years 65 years Both Pregnant or lactating women Allergic to oral hygiene products K05.1 Chronic gingivitis Treatment - Drugs Treatment - Drugs Intervention group: Toothpaste containing extract of persimmon and nigella sativa. For each patient, toothpaste of persimmon extract two times a day for 4 weeks is administered. Herbal extract is prepared by pharmacological research center of medical plants. The indices are evaluated in one month later by periodontist. Control group: Regular toothpaste two times a day for 4 weeks is administered. The indices are evaluated in one month later by periodontist. Gingivitis index. Timepoint: At baseline and week 4 of the trial. Method of measurement: Examination by periodontist with periodontal Williams probe. Plaque index. Timepoint: At baseline, and week 4 of the trial. Method of measurement: Examination by periodontist with periodontal Williams probe. Bleeding on probing. Timepoint: At baseline and week 4 of the trial. Method of measurement: Examination by periodontist with periodontal Williams probe. Mashhad University of Medical Sciences Approved 2025-02-22 Ethics committee of dentistry school, Mashhad University of Medical Sciences Faculty of Dentistry, Azadi Square, East Gate of the University Campus Mashhad Razavi Khorasan Iran (Islamic Republic of)