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The effect of Salvadura Persica on periodontal indices in patients with generalized gingivitis

Protocol summary

Study aim
Evaluation of Salvadora Persica herbal toothbrush in removing plaque and improving periodontal indices compared to conventional toothbrush in patients with generalized gingivitis
Design
Clinical trial with control group, parallel groups, double-blind, randomized, and on 50 patients. Site:www.randomization.com is used for randomization.
Settings and conduct
The study site is Mashhad Dental School. First, the periodontal indices of the subjects are measured and then scaling is performed for them. The subjects are then randomly divided into two groups, one given a Salvadora Persica herbal toothbrush and the other a regular toothbrush. Both groups are taught how to brush efficiently. After 4 weeks of using these devices, patients' periodontal indices are measured again, and compared with before the intervention as well as between the two methods and analyzed statistically. They are also blind assessors, and statistical analysts.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with generalized gingivitis exclusion criteria : 1.Taking anti-inflammatory drugs during the study 2.Systemic diseases such as diabetes and heart disease 3.Addiction and smokers 4.Patients taking immunosuppressive drugs 5.Pregnancy and lactation 6.Advanced gum disease 7.Take antibiotics at least 14 days before and after the study period 8.Severe dental malocclusion and patients receiving orthodontic treatment 9.Sjogren's syndrome
Intervention groups
In the intervention group, after measuring periodontal indices and scaling, Salvadora Persica herbal toothbrush is given to the intervention group, which does not require the use of toothpaste. In the control group, after measuring periodontal indices and scaling, the control group is given a regular toothbrush (one type of brand) with toothpaste .
Main outcome variables
Plaque index; gingival index; bleeding on probing; packet depth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210426051084N1
Registration date: 2022-05-23, 1401/03/02
Registration timing: registered_while_recruiting

Last update: 2022-05-23, 1401/03/02
Update count: 0
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
Hamed Hokmabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3270 6182
Email address
hokmabadh951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-25, 1401/02/05
Expected recruitment end date
2022-05-31, 1401/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Salvadura Persica on periodontal indices in patients with generalized gingivitis
Public title
The effect of Salvadura Persica on periodontal indices in patients with generalized gingivitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients suffering generalized gingivitis
Exclusion criteria:
Systemic diseases such as diabetes and heart disease Addiction and smokers Patients taking immunosuppressive drugs Pregnancy or lactation Advanced gum disease Take antibiotics at least 14 days before and after the study period Severe dental malocclusion and patients receiving orthodontic treatment Taking anti-inflammatory drugs during the study Sjogren's syndrome
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization using the site www.randomization.com. For equal gender distribution, 25 people, including women, are randomly divided into two groups (12 and 13 people) by the randomization site, and to see which group to use what type of toothbrush, We choose between the two groups in a simple random way. Now the numbers obtained from the site For example, numbers 1،6،7،10،11،12،13،14،15،17،21،22،23 (The numbers indicate the order of arrival of the clients). For a group And the numbers 2,3,4,5,5,8,9,16,18,19,20,24,25, we consider for the other group. now we do the same for the male group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Statistical Analyst Blinding Method: The results of each group are divided into two groups with the letters A and B and it is not known which group received which type of toothbrush. Clinical evaluator blinding method (examiner and measurement of required indicators): Toothbrushes are placed in closed packages and its contents are not visible from the outside, it is given to the participants in the study. And the evaluator does not know what type of toothbrush the person receiving received.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committes of School of Dentistry- Mashhad university of medical sciencs
Street address
At the beginning of Vakilabad blvd., in front of Mellat Park, School of Dentistry , mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Approval date
2022-03-07, 1400/12/16
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1400.151

Health conditions studied

1

Description of health condition studied
Generalized gingivitis
ICD-10 code
K05.10
ICD-10 code description
Chronic gingivitis, plaque induced

Primary outcomes

1

Description
Plaque index
Timepoint
Initially studied and 4 weeks after the initial examination
Method of measurement
Silness and Loe plaque index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Salvadora Persica herbal toothbrush (Contains four replaceable heads). Duration of use: four weeks and twice a day, the method of brushing is the bass technique; How to use: the toothbrush head is replaceable and each participant must change the toothbrush head after one week of use; In the first use of the new head, you should chew the new head to open the strands of the plant and then brush your teeth.
Category
Treatment - Other

2

Description
Control group: toothbrush with toothpaste; duration of use: four weeks and twice a day, the method of brushing is the bass technique; the type of toothbrush used is Signal Company's ultra reach toothbrush and the toothpaste used is close-up toothpaste.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Naser Sargolzaie
Street address
Mashhad, at the beginning of Vakilabad Bouleryvard, in front of Mellat Park,
City
mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Email
SargolzaieN@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Khorasan Razavi, Mashhad, Daneshgah St., next to Hoveyzeh Cinema, Ghorashi Building, Deputy of Research and Technology
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@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
naser sargolzaie
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
At the beginning of Vakilabad blvd., in front of Mellat Park
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
0098513806710
Email
sargolzaien@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naser Sargolzaie
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
At the beginning of Vakilabad blvd., in front of Mellat Park
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
0098513806710
Email
sargolzaien@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamed Hokmabadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Mashhad, at the beginning of Vakilabad Bouleryvard, in front of Mellat Park
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3270 6182
Fax
Email
HokmabadH951@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
Not applicable
Data Dictionary
Not applicable
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