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The Effect of Topical Application of Aloe Vera Gel on IL-1B, IL-17 of Crevicular Fluid in patients with chronic Periodontitis

Protocol summary

Study aim
The Effect of Topical Application of Aloe Vera Gel on IL-1B, IL-17 of Crevicular Fluid in patients with chronic Periodontitis
Design
A randomized controlled clinical trial with parallel, single-blind, randomized groups
Settings and conduct
Patient clinical parameters included plaque index (PI by O'Leary 1972 index), gingival index (GI, Loe & Sillness), and probe depth (PD, by Williams 6-tooth probe) at four dental surfaces (mesial, distal, buccal, and lingual) will be reviewed. Then SRP is done. Each person's mouth is randomly divided (dice throw) into two case and control areas. Aloe vera gel will be injected into the periodontal envelope using an insulin syringe. For the opposite control teeth, distilled water replaces the aloe vera gel. Clinical marker measurements will be performed by an examiner who is blind to the type of treatment. IL-1B and IL-17 will be measured using ELISA kit.
Participants/Inclusion and exclusion criteria
Entrance:Moderate to severe chronic periodontitis, Age 35-50, At least 4 teeth with probe depth of 4 mm in each jaw quadrant, Patients candidate for non-surgical treatment Exit:Allergy to Aloe vera, Use of tobacco, Endodontic and periodontal compound lesions, Periapical lesions,Pregnancy, Severe dental caries, Semi-impacted teeth, Orthodontic patients, Systemic diseases and systemic or topical antibiotic users 6 Months befor study, Patients with periodontal disease during the past 6 months and patients receiving periodontal treatment 6 months before study, Patients receiving NSAIDs one month before sampling
Intervention groups
Each person's mouth is randomly divided into two case and control areas. Aloe vera gel will be injected into the periodontal envelope using an insulin syringe. For the opposite control teeth, distilled water replaces the aloe vera gel.
Main outcome variables
Clinical parameters; IL-1B; IL-17

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100412003690N11
Registration date: 2020-02-06, 1398/11/17
Registration timing: prospective

Last update: 2020-02-06, 1398/11/17
Update count: 0
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
Masoomeh Faramarzie
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1385 4863
Email address
faramarzim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Topical Application of Aloe Vera Gel on IL-1B, IL-17 of Crevicular Fluid in patients with chronic Periodontitis
Public title
Evaluation of Alvora Gel in Inflammatory Factors in Patients with Periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe زchronic periodontitis Age 35-50 Have at least 4 teeth with probe depth of 4 mm or more in each jaw quadrant Consent to participate in the study Patients candidate for non-surgical treatment
Exclusion criteria:
Allergy to aloe vera or its products Use of tobacco Endodontic and periodontal compound lesions Periapical lesions Pregnancy Severe dental caries Semi-impacted teeth Orthodontic patients Systemic diseases and systemic or topical antibiotic users 6 Months befor study Patients with periodontal disease during the past 6 months and patients receiving periodontal treatment 6 months before study Patients receiving NSAIDs one month before sampling
Age
From 35 years old to 50 years old
Gender
Both
Phase
4
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 34
More than 1 sample in each individual
Number of samples in each individual: 2
Two areas of the mouth are used as two samples of test and control
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly divided into two intervention groups using dice throwing and even and odd numbers. The intervention group will be the odd numbers and the control group will be even numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
All measurements will be performed by an examiner who is blind to the type of treatment
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-01-06, 1398/10/16
Ethics committee reference number
IR.TBZMED.REC.1398.1113

Health conditions studied

1

Description of health condition studied
Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis

Primary outcomes

1

Description
Plaque Index (PI)
Timepoint
Before entrance in the study and 30 days after initial treatment
Method of measurement
Using the index (O'Leary 1972)

2

Description
Gingival Index (GI)
Timepoint
Before entrance in the study and 30 days after initial treatment
Method of measurement
According to the Loe & Sillness Index

3

Description
Probe depth (PD)
Timepoint
Before entrance in the study and 30 days after initial treatment
Method of measurement
Using Williams probe 6 levels of teeth

4

Description
IL-1B
Timepoint
Before entrance in the study and 30 days after initial treatment
Method of measurement
Using ELISA kit

5

Description
IL-17
Timepoint
Before entrance in the study and 30 days after initial treatment
Method of measurement
Using ELISA kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Aloe vera gel will be injected into the periodontal envelope using an insulin syringe so that the gel enters and fills up to the apical envelope and the gel exits the gingival margin.
Category
Treatment - Drugs

2

Description
Control group: Distilled water will be injected into the periodontal envelope using an insulin syringe so that the water enters and fills up to the apical envelope and exits the gingival margin.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
Full name of responsible person
Masoomeh Faramarzi
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Faramarzim@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Faramarzim@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Masoomeh Faramarzi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1385 4863
Fax
+98 41 1334 6977
Email
ّFaramarzim@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoomeh Faramarzi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1385 4863
Fax
+98 41 1334 6977
Email
Faramarzim@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoomeh Faramarzi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1385 4863
Fax
+98 41 1334 6977
Email
Faramarzim@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data obtained from the participants can be presented in the form of a table. The protocol for the study, which is routine methods, has no problems with its publication. Statistical analysis can also be provided. In this study, an informed consent form will be used that can be published without mentioning the person's name and personal details. A clinical study report can be made after the necessary analyzes.
When the data will become available and for how long
Start the access period 9 months after publishing the results
To whom data/document is available
For researchers in Dental school of Tabriz University
Under which criteria data/document could be used
For scholars working in other academic and academic institutions, if approved by the project implementer
From where data/document is obtainable
Dr. Masoomeh Faramarzi, email or phone Dental school of Tabriz University, Periodontics department, 9144113420 0098 ، faramarzim@tbzmed.ac.ir
What processes are involved for a request to access data/document
After receiving the request will be answered within a week.
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