Assessment of the effect of local application of Aloe Vera gel as a non-surgical adjunctive treatment in type 2 diabetic patients with chronic periodontitis referring to Gorgan dental school
Determination and comparison of pocket probing depth (PPD), clinical attachment level (CAL), gingival index (GI), microbial plaque index (PI) in type 2 diabetic patients with chronic periodontitis in areas treated with scaling and root planing alone And areas treated with scaling and root planing with local application of aloe vera gel before, 1 and 3 months after treatment.
Design
Randomized clinical trial, with control group, with parallel groups, one-way blind, phase 3 on 44 patients, rand function of Excel software was used for randomization.
Settings and conduct
44 patients with type 2 diabetes with moderate to severe chronic periodontitis and referred to the periodontology department of Gorgan Dental School will be considered as the statistical population. The method is split mouth so that randomly in a quadrant of each patient;s jaw, scaling and root planing with local application of aloe vera gel (test group) and in the opposite quadrant Jaw scaling and root planing will be done alone (control group). The purpose of placing periodontal dressing in control areas is to blind the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Patients with type 2 diabetes
2) Being over 18 years old
exclusion criteria:
1) Patients with uncontrolled diabetes (HbA1C> 7)
2) Pregnancy and lactation
Intervention groups
Half of one patient's jaw will be treated only with scaling and root planing (control group) and the other half of the jaw will be treated with scaling and root planing with local application of aloe vera gel (test group).
Main outcome variables
Since there are few similar studies on the application of the topical effect of aloe vera gel in the treatment of periodontal disease and only one similar study has been performed, further studies can improve the results of this study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200919048760N1
Registration date:2020-09-23, 1399/07/02
Registration timing:prospective
Last update:2020-09-23, 1399/07/02
Update count:0
Registration date
2020-09-23, 1399/07/02
Registrant information
Name
Iman Zarei sani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 7350
Email address
zarei.i@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-26, 1399/07/05
Expected recruitment end date
2020-12-25, 1399/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of local application of Aloe Vera gel as a non-surgical adjunctive treatment in type 2 diabetic patients with chronic periodontitis referring to Gorgan dental school
Public title
Assessment of the effect of local application of Aloe Vera gel in treatment of gum inflammation in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic patients
Being over 18 years old
Having at least 20 teeth in the mouth
Having at least one area with an pocket depth of 4 mm and more and with a loss of clinical attachment of 3 mm and more in four or more teeth in at least two quadrants
The need for availability during the research process
Having conscious satisfaction
Exclusion criteria:
Receive systemic or topical antibiotic therapy in the last 3 months
Consumption of antioxidants including vitamin C or E in the last 3 months
Receive scaling and root planing treatment in the last 6 months
History of any periodontal treatment, both surgical and non-surgical, during the last 6 months
Patients undergoing orthodontic treatment
Patients with uncontrolled diabetes (HbA1C> 7)
Tobacco consumption
alcohol consumption
Patients with aggressive periodontitis
Pregnancy and lactation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
44
More than 1 sample in each individual
Number of samples in each individual:
2
Half of one patient's jaw will be treated only with scaling and root planing (control group) and the other half will be treated with scaling and root planing with topical application of aloe vera gel (test group).
Randomization (investigator's opinion)
Randomized
Randomization description
The method is split mouth so that randomly with a pre-prepared randomization list in a quadrant of each patient's jaw, scaling and root planing with local application of aloe vera gel (test group) and in the opposite quadrant Jaw scaling and root planing will be done alone (control group).
Blinding (investigator's opinion)
Single blinded
Blinding description
After applying the gel, all treated areas will be covered with periodontal dressing (coe pack) for 24 hours. The purpose of placing periodontal dressings in test areas is to prevent the gel from being washed away by saliva and to create a longer effect. The purpose of placing periodontal dressing in control areas is to blind the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gorgan University of Medical Sciences
Street address
Faculty of Dentistry, Gorgan University of Medical Sciences, Shahriar Ave 5, Shahriar town
City
Gorgan
Province
Golestan
Postal code
4913983635
Approval date
2020-06-14, 1399/03/25
Ethics committee reference number
IR.GOUMS.REC.1399.104
Health conditions studied
1
Description of health condition studied
Type 2 diabetic patients with chronic periodontitis
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Type 2 diabetic patients with chronic periodontitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
probing pocket depth (PPD) in millimeters Clinical attachment level (CAL) in millimeters Gingival index (GI) in terms of graded determination plaque index (PI) in percentage
Timepoint
The time of measurement of variables is at the beginning of the study (before the intervention), 1 month and 3 months after treatment.
Method of measurement
probing pocket depth (PPD) in millimeters by Williams periodontal probe Clinical attachment level (CAL) in millimeters by Williams periodontal probe. Gingival index (GI) according to the assigned grading: GI0 (normal): Pink gums Normal, non-inflammatory GI1 (mild): Slightly discolored gums, Negative BOP GI2 (moderate): Red, shiny, swollen gums, Positive BOP GI3 (severe): Gums red, swollen, with spontaneous sores and bleeding / Examination with periodontal probe . Plaque index (PI): How to measure PI: (Number of painted surfaces * 100) / (Number of teeth * 4) Percentage: Optimal: 0-30 Medium: 31-50 Unfavorable: 51-100
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The procedure will be in the form of a split mouth in such a way that randomly with a pre-prepared randomization list, half of one patient's jaw is treated only with scaling and root planing (control group) and half The other jaw will be treated with scaling and root planing with local application of aloe vera gel (test group). In the control quadrant, scaling areas and planing of roots and gingival pockets are routinely washed with distilled water. The aloe vera gel used in this study contains 98% pure aloe vera gel obtained from the leaves of the aloe vera plant plus 2% emulsifier. To prepare the gel, first wash the leaves of aloe vera with water and then disinfect them. Remove the green leaf part of the leaf and keep the gel released from it in a sterile container. The emulsifier has no therapeutic properties and its purpose is only to stabilize and maintain the gel state. The gel is inserted passively through an insulin syringe from the base of the periodontal pocket to the marginal edge of the patient's gums without applying any force so that some of the gel leaks out of the gingival margin. One week after the first stage of treatment, the patient will be placed the gel again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Gorgan University of Medical Sciences
Full name of responsible person
Iman Zarei Sani
Street address
Faculty of Dentistry, Gorgan University of Medical Sciences, Shahriar Ave 5, Shahriar town
City
Gorgan
Province
Golestan
Postal code
4913983635
Phone
+98 51 4464 7350
Email
zarei.i@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohamad Reza Honarvar
Street address
Hyrkan Blvd., Central Organization of Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4913983635
Phone
+98 17 3245 1654
Email
zarei.i@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Iman Zarei Sani
Position
collegian
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Gorgan University of Medical Sciences, Shahriar Ave 5, Shahriar town
City
Gorgan
Province
Golestan
Postal code
4913983635
Phone
+98 17 3262 7824
Email
zarei.i@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Aida Mirzaee
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Gorgan University of Medical Sciences, Shahriar Ave 5, Shahriar town
City
Gorgan
Province
Golestan
Postal code
4913983635
Phone
+98 17 7824 3262
Email
Ida.mirzaee65@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Iman Zarei sani
Position
Collegian
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental school, Shahriar Ave 5, Shahriar town
City
Gorgan
Province
Golestan
Postal code
4913983635
Phone
+98 51 4464 7350
Fax
Email
zarei.i@goums.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Patients' periodontal charts will be published, which include details of the variables.
When the data will become available and for how long
The start of the document access period is a maximum of 1 year after the results are published.
To whom data/document is available
The research documents will be provided to academic researchers.
Under which criteria data/document could be used
The documentation of this study should be used in order to make researchers more familiar with how to record data for further studies.
From where data/document is obtainable
To receive the documents, send a message to Ida.mirzaee65@gmail.com in the name of Dr. Aida Mirzaei.
What processes are involved for a request to access data/document
The study documents will be sent to the applicant researcher after verifying his / her identity.