Investigating the effectiveness of toothpaste containing persimmon and Nigella sativa in the treatment of patients with gingivitis

Effectiveness of toothpaste containing persimmon and Nigella sativa extract in the treatment and reduction of symptoms of gingivitis patients

In this clinical trial, 56 patients will be randomly and double-blindly assigned in equal numbers to two groups using a random number table: the intervention group (toothpaste containing persimmon and Nigella sativa extract) and the control group (regular toothpaste).

Fifty-six patients with gingivitis, selected from outpatients at the School of Dentistry, Mashhad University of Medical Sciences, were randomly and double-blindly assigned in equal numbers to two groups. Unlabeled toothpaste was provided to patients in both groups. The toothpaste containing persimmon and Nigella sativa extract was prepared by the pharmacological research center of Medicinal Plants of Mashhad University of Medical Sciences. A periodontist will examine the patients one month later. Patients are instructed not to use any other toothpaste on their own during the study period.

Inclusion criteria: Gingivitis patients, having at least 18 natural teeth Exclusion criteria: Pregnant or breastfeeding women, and individuals with known allergies to oral hygiene products

For each patient, toothpaste two times a day (herbal extract or control) for 4 weeks is administered. Persimmon and Nigella sativa extract is prepared by pharmacological research center of medical plants. The indices are evaluated in one month later by periodontist.

Gingivitis index, Plaque index, Bleeding on probing

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.

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.