Determining the comparison of the effectiveness of black seed mouthwash with chlorhexidine mouthwash in improving gingivitis
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, on 36 patients, simple random method will be used for randomization.
Settings and conduct
36 people aged 20 to 40 who referred to the Periodontology Department of Yazd Dental School will be divided into two groups of 18 people and one group will be given black seed mouthwash and the other group will be given chlorhexidine mouthwash. Both mouthwashes will be put in similar bottles, the contents of which are not known.
In order to blind the researcher, the researcher who examines and performs the measurements will have no knowledge of the type of substance inside the bottles.
We will explain to the participants to use 10 ml of prescribed mouthwash twice a day for 30 seconds. Bass modified method and flossing will also be taught to them.
Participants/Inclusion and exclusion criteria
Referees to the Periodontology Department of Yazd School of Dentistry
Intervention groups
People will be divided into two groups of 18 people and one group will be given black seed mouthwash and the other group will be given chlorhexidine mouthwash. The two groups will tried to be the same in terms of gender and age distribution.
Main outcome variables
Plaque index according to the O'Leary index plaque criterion; Bleeding index according to bleeding index criteria; Tooth color change according to stain index criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221212056786N2
Registration date:2023-10-03, 1402/07/11
Registration timing:retrospective
Last update:2023-10-03, 1402/07/11
Update count:0
Registration date
2023-10-03, 1402/07/11
Registrant information
Name
Seyed mohammad Arab farashahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3621 2222
Email address
sm.arab@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of nigella sativa mouthwash with chlorhexidine mouthwash on improvement of gingivitis
Public title
Comparison of effectiveness of nigella sativa mouthwash with chlorhexidine mouthwash on improvement of gingivitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No attachment loss
Probing depth lower than 3 milimeters
Under no orthodontics or prosthetic treatments
Plaque index 1 or more in 60% areas
At least 20 teeth
Bleeding on probing in at least 30% of areas
Exclusion criteria:
Having a systemic disease
Using antibiotics in the last 3 months
Allergic to nigella sativa
Using drugs affecting periodontium
Lack of co-operation in the study
Not using the mouthwash for 2 times
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign qualified people to two groups, the Random allocation software version 2 will be used, and the random allocation method will be also a simple random method. First, the first eligible person will get number 1, and then the eligible people will get number 36, and based on the random allocation done by the software, each person will receive medicine A or B. In order to blind the random allocation, the list of random allocation will be provided to another person who is not in the study and before the patient's visit based on the number, the individual's treatment group will be asked by the third person by phone or SMS.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both mouthwashes will be put in similar bottles, the contents of which are not known. In order to blind the researcher, the researcher herself, who examines and performs the measurements, will have no knowledge of the type of substance inside the bottles.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Investigating gingivitis and tooth discoloration after using mouthwash
Timepoint
Examining gingivitis and tooth discoloration at the beginning of the study and after two weeks
Method of measurement
Examining the plaque index using the O'Leary index plaque criterion and bleeding index using the bleeding index criterion and tooth discoloration using the stain index criterion
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group is given Nigella sativa mouthwash. Patients are told to use 10 milliliters of mouthwash twice a day for 30 seconds for two weeks. The extract is obtained from a grocery in Yazd and used to produce mouthwash. Mouthwash is prepared with a concentration of 20%.
Category
Prevention
2
Description
Control group: This group is given chlorhexidine mouthwash. 0.2% chlorhexidine solution (Shahr Daru, Iran) is used twice a day, 10 ml each time, for 30 seconds for two weeks.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology, Faculty of Dentistry, Yazd