Clinical evaluation of Nigella sativa chewing gum on generalized gingivitis
Design
A randomized, double-blind, placebo-controlled phase 3 clinical trial with parallel groups on 80 patients. Randomization using Randomaization.com
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Plaque Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054874N21
Registration date:2024-11-04, 1403/08/14
Registration timing:prospective
Last update:2024-11-04, 1403/08/14
Update count:0
Registration date
2024-11-04, 1403/08/14
Registrant information
Name
Vafa Baradaran Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2301
Email address
baradaranrv@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-05, 1403/08/15
Expected recruitment end date
2026-11-06, 1405/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of Nigella sativa chewing gum on generalized gingivitis
Public title
The effect of Nigella sativa chewing gum on generalized gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's committee of Mashhad University of Medical Sciences
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2024-08-03, 1403/05/13
Ethics committee reference number
IR.MUMS.REC.1403.251
Health conditions studied
1
Description of health condition studied
Chronic gingivitis
ICD-10 code
K05.01
ICD-10 code description
Acute gingivitis, non-plaque induced
Primary outcomes
1
Description
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)
Secondary outcomes
1
Description
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)
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics affiliated with Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vahid Reza Askari
Street address
Mashhad University of Medical Science, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
askariv@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available