Determining and comparing the rate of changes in gingivitis and depth of periodontal pocket and plaque index in the intervention and comparison group before and after chewing gum
Design
A clinical trial with an intervention and comparison group, with parallel, double-blind, randomized, phase 3 groups on 32 patients, a random number table was used for randomization.
Settings and conduct
This study is an interventional and double-blind clinical trial performed on patients with fixed orthodontics. The patients will randomly divided into two groups of intervention and comparison. Patients are selected voluntarily from among the patients referred to Hamadan Dental School of Medical Sciences. Plaque index and gingival index variables and periodontal pocket depth are measured in two groups of intervention and comparison at the time of admission, one month later and two months later. Participants and researchers in this study are blind. Randomization is performed using a table of random numbers.
Participants/Inclusion and exclusion criteria
Inclusion criteria for people with a fixed treatment plan
Exclusion criteria for people with a history of systemic disease and dental caries and the use of any type of mouthwash and other medication or chewing gum during the research period
Intervention groups
The intervention group includes patients with gingivitis who receive chewing gum containing Crocus sativus petal extract.
The control group includes patients with gingivitis who receive chewing gum without extract.
Main outcome variables
Gingival index; Probing depth; Plaque index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150802023468N7
Registration date:2021-05-19, 1400/02/29
Registration timing:prospective
Last update:2021-05-19, 1400/02/29
Update count:0
Registration date
2021-05-19, 1400/02/29
Registrant information
Name
Nazli Rabienejad
Name of organization / entity
Hamadan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1059
Email address
n.rabinezhad@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of gum containing petal extract of crocus sativus on gingival inflammation in fixed orthodontic patients
Public title
Evaluation the effect of gum containing petal extract of crocus sativus on gingival inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fixed orthodontic treatment plan
Exclusion criteria:
Systemic disease
Tooth decay
Use mouthwash or any other medication and gum during study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is block by size 4 blocks. Randomization is performed using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant and the investigator are both blind. Chewing gum packaging is similar to the comparison and intervention group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Mardom street
City
Hamadan
Province
Hamadan
Postal code
6517736134
Approval date
2021-01-16, 1399/10/27
Ethics committee reference number
IR.UMSHA.REC.1399.878
Health conditions studied
1
Description of health condition studied
gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis: NOS desquamative hyperplastic simple marginal ulcerative
Primary outcomes
1
Description
gingival index
Timepoint
Baseline, one and two months after
Method of measurement
Inspection
2
Description
Probing depth
Timepoint
Baseline, one and two months after
Method of measurement
Periodontal probe
3
Description
Plaque index
Timepoint
Baseline, one and two months after
Method of measurement
Inspection
Secondary outcomes
1
Description
Analgesic effect
Timepoint
One day, two days and three days after starting chewing gum
Method of measurement
Visual Analogue Scale Questionnaire
Intervention groups
1
Description
Intervention group: The hydroalcoholic extract of Crocus sativus petal plant was extracted by soaking method and dried and concentrated by rotary distillation in vacuum, then gum containing Crocus sativus was produced in Mana and Dana factory with acceptable concentration. Patients use chewing gum twice a day for two months after each brushing.
Category
Treatment - Other
2
Description
Control group: Placebo chewing gum was produced in Mana and Dana factories without any extract. Patients use chewing gum twice a day for two months after each brushing.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Dental Faculty
Full name of responsible person
Nazli Rabinejad
Street address
Hamadan Dental Faculty, Mardom street
City
Hamadan
Province
Hamadan
Postal code
6517736134
Phone
+98 81 3838 1059
Email
nasimkhademi1396@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Hamadan University of Medical Sciences, Mardom street
City
Hamadan
Province
Hamadan
Postal code
6517736134
Phone
+98 81 3838 1059
Email
nasimkhademi1996@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nasim Khademi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Periodontology Department, Hamadan Dental Faculty
City
Hamadan
Province
Hamadan
Postal code
6517736134
Phone
+98 81 3838 1059
Email
nasimkhademi1996@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nasim Khademi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Periodontology Department, Hamadan Dental Faculty
City
Hamadan
Province
Hamadan
Postal code
6517736134
Phone
+98 81 3838 1059
Email
nasimkhademi1996@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nasim Khademi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Periodontology Department, Hamadan Dental Faculty
City
Hamadan
Province
Hamadan
Postal code
6517736134
Phone
+98 81 3838 1059
Email
nasimkhademi1996@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD