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IRCT20220516054874N21 IRCT 2024-11-04 Mashhad University of Medical Sciences The effect of Nigella sativa chewing gum on generalized gingivitis Clinical evaluation of Nigella sativa chewing gum on generalized gingivitis 2024-11-05 anticipated 80 Recruiting https://irct.ir/trial/79862 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocked randomization method is used. The block size will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 20 blocks according to the sample size of 80. Then, random numbers between 1 and 20 are selected according to the randomization site Randomaization.com, and finally, the treatment allocation list is determined based on the random numbers, Blinding description: Blinding will performed using sealed envelopes. Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B. 3 Chronic gingivitis. Intervention 1: Intervention group: Patients with generalized gingivitis chew black seed extract chewing gum (containing 5% black seed extract) twice a day (once in the morning after breakfast and once at night before going to bed) for 20 minutes in addition to standard treatment. This will continue for 14 days. The black seed extract chewing gum will be provided by Daru Azma Rasa Gostar Fartak company. Intervention 2: Control group: Patients with generalized gingivitis chew placebo chewing gum twice a day (once in the morning after breakfast and once at night before going to bed) for 20 minutes in addition to standard treatment. This will continue for 14 days. The black seed extract chewing gum will be provided by Daru Azma Rasa Gostar Fartak company. 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 Undecided - It is not yet known if there will be a plan to make this available
public Dr. Vafa Baradaran Rahimi
Ghaeem hospital, Ahmadabad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 0095 5138012739 baradaranrv@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Vafa Baradaran Rahimi
Ghaeem hospital, Ahmadabad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 0095 5138012739 baradaranrv@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with chronic generalized gingivitis Consent to admission to the study Having at least 18 natural teeth Having an average corrected gingival index of all teeth between 1.3 and 2.75 Having the average modified plaque index of all teeth at least 1.5 18 years no limit Both Smoking history Inability to attend follow-up meetings Patients receiving other systemic or local antibiotics K05.1 Chronic gingivitis Treatment - Drugs Placebo Intervention group: Patients with generalized gingivitis chew black seed extract chewing gum (containing 5% black seed extract) twice a day (once in the morning after breakfast and once at night before going to bed) for 20 minutes in addition to standard treatment. This will continue for 14 days. The black seed extract chewing gum will be provided by Daru Azma Rasa Gostar Fartak company. Control group: Patients with generalized gingivitis chew placebo chewing gum twice a day (once in the morning after breakfast and once at night before going to bed) for 20 minutes in addition to standard treatment. This will continue for 14 days. The black seed extract chewing gum will be provided by Daru Azma Rasa Gostar Fartak company. Plaque Index. Timepoint: The beginning of the study and 14 days later. Method of measurement: According to the PI index (0-10; 0 is without plaque, and 3 is the accumulation of a large amount of soft material in the gums, on the teeth, or at the edge of the gums). Loe & Silness Gingival Index. Timepoint: The beginning of the study and 14 days later. Method of measurement: According to the Loe & Silness index (0-3; 0 is the normal gums and 3 is the severe inflammation). Mashhad University of Medical Sciences Approved 2024-08-03 Ethic's committee of Mashhad University of Medical Sciences Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)