Protocol summary
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Study aim
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Clinical evaluation of Nigella sativa chewing gum on generalized gingivitis
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Design
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A randomized, double-blind, placebo-controlled phase 3 clinical trial with parallel groups on 80 patients. Randomization using Randomaization.com
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Settings and conduct
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This study will be performed in the Department of Periodontology, Faculty of Dentistry, Mashhad. Patients are randomly assigned to Nigella sativa chewing gum and placebo groups. The patients and the main researcher are unaware of the group assignment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with chronic generalized gingivitis; Consent to admission to the study; Having at least 18 natural teeth.
Exclusion criteria: Smoking history; Inability to attend follow-up meetings.
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Intervention groups
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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.
Placebo 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.
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Main outcome variables
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Plaque Index
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:
IRCT20220516054874N21
Registration date:
2024-11-04, 1403/08/14
Registration timing:
prospective
Last update:
2025-07-14, 1404/04/23
Update count:
1
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Registration date
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2024-11-04, 1403/08/14
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2024-11-05, 1403/08/15
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Expected recruitment end date
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2026-11-06, 1405/08/15
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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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Clinical evaluation of Nigella sativa chewing gum on generalized gingivitis
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Public title
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The effect of Nigella sativa chewing gum on generalized gingivitis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
Smoking history
Inability to attend follow-up meetings
Patients receiving other systemic or local antibiotics
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Data analyser
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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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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2024-08-03, 1403/05/13
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Ethics committee reference number
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IR.MUMS.REC.1403.251
Health conditions studied
1
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Description of health condition studied
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Chronic 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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Plaque Index
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Timepoint
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The beginning of the study and 14 days later
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Method of measurement
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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)
Secondary outcomes
1
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Description
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Loe & Silness Gingival Index
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Timepoint
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The beginning of the study and 14 days later
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Method of measurement
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According to the Loe & Silness index (0-3; 0 is the normal gums and 3 is the severe inflammation)
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available