Evaluation of the effect of non-invasive periodontal therapy(SRP) on levels of salivary biomarkers of mmp7 and mucin4 in patients with moderate to severe chronic periodontitis
Determination of the effect of scaling on the amount of saliva mp7 and mp4 biomarkers in patients with moderate to severe chronic periodontitis
Design
A clinical trial with a community-based control group was performed randomly.
Settings and conduct
A study was conducted at the dental clinic of Bushehr University of Medical Sciences. In this clinical trial study, 40 patients in the age group of 30-60 years old were randomly assigned to two groups according to the criteria for entering and leaving the study.
Patients in both groups receive saliva samples before each intervention. Patients are asked to spray their non-stimulated saliva in sterile microtiles for 2 minutes. Saliva samples to determine the enzyme concentration in the biochemical laboratory Transferred and centrifuged for 10 minutes at 4 ° C and freeze-dried immediately after removal of the supernatant at -40 ° C until the measurements are carried out.
Then, for the group of patients (intervention group), the scaling procedure (as the main intervention intervention), along with oral hygiene education (OHI), as well as the daily administration of 10 mg daily chlorhexidine degluconate solution for 2 weeks, for one week For the second group (control group), only oral health education (OHI) and mouthwash administration are presented with a similar pattern to the intervention group. Patients in both groups receive saliva samples again one month after the intervention, and in both patients the clinical status of periodontitis is evaluated.
Participants/Inclusion and exclusion criteria
Patients aged 30-60 years with moderate to severe chronic periodontitis
Intervention groups
Patients aged 30-60 years with moderate to severe chronic periodontitis
Main outcome variables
mucin4; mmp7
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180521039761N1
Registration date:2018-08-25, 1397/06/03
Registration timing:retrospective
Last update:2018-08-25, 1397/06/03
Update count:0
Registration date
2018-08-25, 1397/06/03
Registrant information
Name
najmeh shooraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 3226
Email address
n.shooraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
2018-05-22, 1397/03/01
Actual recruitment end date
2018-07-23, 1397/05/01
Trial completion date
empty
Scientific title
Evaluation of the effect of non-invasive periodontal therapy(SRP) on levels of salivary biomarkers of mmp7 and mucin4 in patients with moderate to severe chronic periodontitis
Public title
Evaluation of the effect of SRP on levels of salivary biomarkers of mmp7 and mucin4 in patients with moderate to severe chronic Tissue Inflammation
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate to severe periodontitis from 30 to 60 years of age
Exclusion criteria:
Pregnancy
History of smoking and alcohol
Chronic inflammatory diseases of the skin and oral mucosa
Systemic diseases that affect periodontal conditions
Periodontal acute diseases such as periodontal abscesses
Radiographic evidence of visible bone resorption in posterior B.W
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The study samples were selected based on the criteria for entering and leaving the study. For random allocation random sampling, two groups of intervention and control group were used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of bushehr university of medical sciences
Street address
Dental clinic; Heidari ave.
City
bushehr
Province
Boushehr
Postal code
7514633341
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.BPUMS.REC.1396.203
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
MUCIN4/MMP7
Timepoint
Before starting the study and one month later
Method of measurement
ELISA Kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group of patients for whom oral contraceptive practice (OHI) and oral administration of 2 ml of 10 ml of .2% chlorhexidine d-gluconate solution are administered for one week for oral administration.
Category
Diagnosis
2
Description
Control group: For the control group, only Oral Hygiene (OHI) and oral chloride.2% are prescribed. Patients are asked to refer to the saliva for one month after receiving saliva
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Bushehr university of medical sciences
Full name of responsible person
Najmeh shooraki
Street address
Heydari ave.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3332 3123
Email
Daneshmandmojtaba@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Heydari ave.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3332 2081
Email
n.shooraki@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Najmeh Shooraki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Heidary ave.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3332 2081
Email
N.shooraki@bpums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Najmeh Shooraki
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mosalla Ave., moallem Blvd., kuy-e-bandar
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 3226
Fax
+98 77 3332 3226
Email
n.shooraki@bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Najmeh Shooraki
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mosalla Ave., moallem Blvd., kuy-e-bandar
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 3226
Fax
+98 77 3332 3226
Email
n.shooraki@bpums.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
0
When the data will become available and for how long
0
To whom data/document is available
0
Under which criteria data/document could be used
0
From where data/document is obtainable
0
What processes are involved for a request to access data/document