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Assessment of the effect of local application of Aloe vera gel as an non-surgical adjunctive treatment in patients with chronic periodontitis

Protocol summary

Study aim
The effect of topical application of aloe vera gel in the surgical treatment of chronic periodontitis Determine and compare the values probing pocket depth, clinical attachment loss, gingival indexT plaque index
Design
A double-blind randomized clinical trial, sample size 22, as a splint mouth, which is a control and self-test group
Settings and conduct
Gorgan Dental Clinic، split mouth procedure with randomized pre-prepared list of half of jaws treated only with scaling and rootplaning and the other half with scaling and rootplaning with topical use of aloe vera gel. After that all treated areas will be covered with periodontal dressing for 24 hours. The purpose of periodontal dressing in the control areas to blind the patient. All parameters will be performed by another clinician with no information on the nature of the patient's received treatment. As a result of which the evaluator will be blinded.
Participants/Inclusion and exclusion criteria
Entry requirements: at least 18 years, having at least 20 teeth, having at least one area with a pocket depth of 4 mm and more in at least two quadrants, having at least one area with clinical attachment loss of 3 mm and more at least two quadrants, necessity of availability During the research process, having informed consent Exclusion criteria:systemic disease, aloe vera allergy and its products, systemic or topical antibiotic therapy in the past 3 months , Antioxidants including vitamin C or E in the past 3 months, scaling and root planning treatment in the past 6 months, smoking and alcohol consumption, pregnancy and lactation
Intervention groups
The procedure is split mouth so that scaling and root planing can be done for all teeth. The aloe vera gel will then be randomly assigned to the half of patient's jaw(test group).
Main outcome variables
Depth of pocket,Clinical attachment loss,Gingival index,plaque index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191113045428N1
Registration date: 2019-12-19, 1398/09/28
Registration timing: prospective

Last update: 2019-12-19, 1398/09/28
Update count: 0
Registration date
2019-12-19, 1398/09/28
Registrant information
Name
Shaghayegh Vadoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3223 1252
Email address
vadodi.sh@goums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2019-12-21, 1398/09/30
Expected recruitment end date
2620-04-19, 1999/01/30
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 an non-surgical adjunctive treatment in patients with chronic periodontitis
Public title
Aloe vera in periodontits
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being over 18 years old Having at least 20 teeth in the mouth Having at least one area with probing depth of 4 mm or more in at least two quadrants Having at least one area of clinical attachment loss of 3 mm or more in at least two quadrants Necessity to be available during the research process Having informed consent
Exclusion criteria:
The presence of systemic disease affecting periodontal status Sensitivity to aloe vera and its products Receive systemic or topical antibiotic therapy in the past 3 months Antioxidants intake of vitamin C or E in the past 3 months Scaling and root planing treatment in the past 6 months Smoking Alcohol consumption Pregnancy and lactation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
The procedure will be split mouth in such a way that randomly with a pre-arranged randomization by random number table list half of the jaw is treated only with scaling and root planing and the other half with scaling and root planing with Topical use of aloe vera gel will be. After gel application, all treated areas will be covered with periodontal dressing for 24 hours. The purpose of periodontal dressing in the test areas is to prevent the saliva from gaining gel and in the control areas to blind the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant is kept blind as he does not know which quadrant of the jelly is placed because all the parts are put on periodontal dressing.The measuring clincian is kept blind and does not know where the gel is inserted when measuring the parameters.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Dental clinic, Edalat 97 Ave., Naharkhoran Blvd.
City
Gorgan
Province
Golestan
Postal code
4916953358
Approval date
2019-11-11, 1398/08/20
Ethics committee reference number
IR.GOUMS.REC.1398.252

Health conditions studied

1

Description of health condition studied
Chronic periodontitis is an inflammatory periodontal disease caused by the penetration of germs into the inflamed gums, resulting in periodontal tissue destruction and alveolar bone loss. Chronic periodontitis is the most common form of periodontitis.
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis

Primary outcomes

1

Description
Probing Pocket Depth
Timepoint
Before starting the study, 1 and 3 months later
Method of measurement
Distance of free gingival margin to base of gingival groove by periodontal probe Williams

2

Description
Clinical Attachment Loss
Timepoint
Before starting the study, 1 and 3 months later
Method of measurement
Distance of Cemento Enamel Junction to base of gingival groove by periodontal probe Williams

3

Description
Gingival Index
Timepoint
Before starting the study, 1 and 3 months later
Method of measurement
Specified number to determine the degree: Gingival Index0 (normal), Gingival Index1 (mild), Gingival Index2 (medium), Gingival Index3 (severe)

4

Description
Plaque Index
Timepoint
Before starting the study, 1 and 3 months later
Method of measurement
Percentage of adherent microbial plaque on tooth surface: Desirable: 0-30 Average: 31-50 Undesirable: 51-100

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Before starting treatment, patients are subjected to the same hygiene training and are asked to use Orchid floss twice a day to clean interdental surfaces, followed by bass technique and Dr.West (soft) tooth brushing and toothpaste Merident Brush their teeth.A week later clinical parameters, measurements and treatment will begin.The procedure will be split mouth.That is, it will be randomly treated with a pre-made randomization list of half of a jaw under scaling and root planing with Aloe vera gel will be treated twice a week with topical application.
Category
Treatment - Drugs

2

Description
Control group: Before starting treatment, patients are subjected to the same hygiene training and are asked to use Orchid floss twice a day to clean interdental surfaces, followed by bass technique and Dr.West (soft) tooth brushing and toothpaste Merident Brush their teeth.A week later clinical parameters, measurements and treatment will begin.The procedure will be split mouth. In the control group the other half of the jaw is treated only with scaling and root planing.In fact, the effectiveness of a substance is measured by each individual
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Gorgan Dental School
Full name of responsible person
Ida Mirzaei
Street address
Dental clinic, Edalat 97 Ave., Naharkhoran Blvd.
City
Gorgan
Province
Golestan
Postal code
4916953358
Phone
+98 17 3255 0565
Email
Drmirzaei.a@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Ida Mirzaei
Street address
Dental clinic, Edalat 97 Ave., Naharkhoran Blvd.
City
Gorgan
Province
Golestan
Postal code
4916953358
Phone
+98 17 3255 0565
Email
Drmirzaei.a@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
Shaghayegh Vadoudi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental clinic, Edalat 97 Ave., Naharkhoran Blvd.
City
Gorgan
Province
Golestan
Postal code
4916953358
Phone
+98 17 3255 0565
Email
Vadodi.sh@goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Ida Mirzaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental clinic, Edalat 97 Ave., Naharkhoran Blvd.
City
Gorgan
Province
Golestan
Postal code
4916953358
Phone
+98 17 3255 0565
Email
Drmirzaei.a@goums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Ida Mirzaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental clinic, Edalat 97 Ave., Naharkhoran Blvd.
City
Gorgan
Province
Golestan
Postal code
4916953358
Phone
+98 17 3255 0565
Email
Drmirzaei.a@goums.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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after publishing results
To whom data/document is available
Professors and Students of Medical Sciences Universities
Under which criteria data/document could be used
No conditions
From where data/document is obtainable
Using the available e-mail
What processes are involved for a request to access data/document
If available, the data will be provided to the requested person within 2 months .
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