Effect of hyaluronic acid(HA) on scaling & root planning treatment in patients with chronic periodontitis
Design
One-blind randomized controlled clinical trial, phase 3 on 24 patients. Randomization of this study is done using a table of random numbers, which is done with Random Allocation software.
Settings and conduct
In this one-blind study, 24 patients with moderate to severe chronic periodontitis who refer to the periodontology department of Shahid Sadoughi Dental School of Yazd for periodontal treatment will be randomly selected and examined.
Participants/Inclusion and exclusion criteria
Patients should be systemically healthy؛ have at least 5 teeth per maxillary quadrant؛ and have moderate to severe chronic periodontitis.
No allergy to hyaluronic acid؛ They should also not be treated orthodontically and should not use mouthwash for the past 6 months.
Intervention groups
The gel is injected in one quadrant and the other quadrant is the control group.
Main outcome variables
Plaque index؛ Bleeding on probing؛ Clinical attachment loss؛ Pocket depth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171015036782N7
Registration date:2022-01-09, 1400/10/19
Registration timing:registered_while_recruiting
Last update:2022-01-09, 1400/10/19
Update count:0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
farzane vaziri
Name of organization / entity
Shahid sadoughi dental university
Country
Iran (Islamic Republic of)
Phone
+98 35 3620 4764
Email address
f.vaziri@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hyaluronic acid)HA) on scaling & root planning treatment in patients with chronic periodontitis
Public title
Effect of hyaluronic acid)HA) on scaling & root planning treatment in patients with chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
they have moderate to severe periodontitis
they Have at least 5 teeth in each maxilla quadrant
They are not allergic to(hyaluronic acid) HA.
Patients should not be treated orthodontically and should not use mouthwash for the past 6 months.
Exclusion criteria:
pregnancy
smoker
hypertention
Chronic systemic diseases including diabetes and allergies
Patients who have been receiving periodontal or antibiotic treatment for the past 6 months
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
We will define a code for each patient with moderate to severe chronic periodontitis, who have referred to the periodontal department of the dental school for periodontal treatment and are eligible to enter the study, and we will enter these codes in the Random Allocation software. . Then, using software, we randomly select 36 codes in two groups of 18 to enter the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of yazd University of Medical Sciences
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Razavi Khorasan
Postal code
8916147860
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.SSU.REC.1400.136
Health conditions studied
1
Description of health condition studied
moderate to severe chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Probing depth
Timepoint
Beggining of study and 6 week later
Method of measurement
Williams probe
2
Description
Clinical Attachment Loss
Timepoint
Beggining of study and 6 week later
Method of measurement
Using the Williams probe
3
Description
Bleeding on probing
Timepoint
Beggining of study and 6 week later
Method of measurement
by observation of Bleeding on probing in the mouth and measuring its percentage
4
Description
plaque index
Timepoint
Beggining of study and 6 week later
Method of measurement
observation of plaque
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: non-surgical periodontal treatment and use 1% hyaluronic acid gel subcutaneously twice with an interval of one week in the right quadrant of the maxilla
Category
Treatment - Drugs
2
Description
Control group: non-surgical periodontal treatment in the left quadrant of the maxilla
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Milad Eidy
Street address
Shahid Sadoughi Faculty of Dentistry Yazd, Emam Reza square
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
miladeidy1372@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mostafa mahmoodi
Street address
Shahid Sadoughi Faculty of Dentistry Yazd, Emam Reza Square
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
miladeidy1372@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Milad eidy
Position
Post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Yazd
Postal code
8916147860
Phone
+98 35 3830 1323
Email
miladeidy1372@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Milad eidy
Position
Post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Yazd
Postal code
8916147860
Phone
+98 35 3830 1323
Email
miladeidy1372@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Milad eidy
Position
Post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Yazd
Postal code
8916147860
Phone
+98 35 3830 1323
Email
miladeidy1372@gmail.com
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
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
Undecided - It is not yet known if there will be 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
The whole data is shared
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Email, Call
From where data/document is obtainable
milad eidy.09919635479, miladeidy1372@gmail.com
What processes are involved for a request to access data/document
After sending the Email, the data will be transmitted