This study aim to assess the effect of non-surgical periodontal therapy on level of pentraxin-3 in gingival crevicular fluid of chronic periodontitis patients
Design
The control group consists of 25 healthy individuals between 25 to 50 years who had no history of periodontal disease.The patient group comprise of 25 patients with generalized moderate chronic periodontitis between 25 to 50 years.
Settings and conduct
Gingival crevicular fluid (GCF)samples collect from the patients and controls , who visit the periodontology department at Qazvin University of Medical Sciences ,using paper strips to assess the level of pentraxin-3. In the patient group, GCF samples collect again 6 weeks after scaling and root planing from the same area.All samples are coded and blindly send to the laboratory .The level of pentraxin-3 in the GCF is quantified using enzyme-linked immunosorbent assay.
Participants/Inclusion and exclusion criteria
The control group consists of 25 healthy individuals between 25 to 50 years who had no history of periodontal disease.The patient group comprise of 25 patients with generalized moderate chronic periodontitis between 25 to 50 years. The exclusion criteria are systemic conditions such as respiratory and cardiovascular diseases, diabetes mellitus, HIV, chemotherapy, pregnancy or nursing, antibiotic therapy, medication intake, periodontal treatment in the past 6 months, smoking, infectious diseases and any sign/symptom of infection.
Intervention groups
Scaling and root planing in the patient group
Main outcome variables
Compare the level of pentraxin-3 of patients before treatment with control group ؛ Compare the level of pentraxin-3 of patients before treatment with 6 weeks after treatment ؛ Compare the level of pentraxin-3 of patients 6 weeks after treatment with control group ؛ Comare periodontal indices with laboratory findings
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044253N1
Registration date:2019-08-28, 1398/06/06
Registration timing:retrospective
Last update:2019-08-28, 1398/06/06
Update count:0
Registration date
2019-08-28, 1398/06/06
Registrant information
Name
Mahtab Samieifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 1408
Email address
m.samieifar@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-10, 1396/06/19
Expected recruitment end date
2017-12-10, 1396/09/19
Actual recruitment start date
2017-09-22, 1396/06/31
Actual recruitment end date
2017-12-20, 1396/09/29
Trial completion date
2018-02-09, 1396/11/20
Scientific title
Effect of non-surgical periodontal therapy on pentraxin-3 concentration in gingival crevicular fluid of chronic periodontitis patients
Public title
Pentraxin-3 concentration in gingival crevicular fluid
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
25 to 50 years
Patients with moderate periodontitis (patient group)
No history of periodontal disease (control group)
Exclusion criteria:
Systemic conditions such as respiratory and cardiovascular diseases, diabetes mellitus, HIV, chemotherapy, pregnancy or nursing
Antibiotic therapy, medication intake in the past 6 months,
Smokers
Infectious diseases and any sign/symptom of infection.
Periodontal treatment in the past 6 months
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
N/A
Randomization description
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 Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Blvd,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2017-07-10, 1396/04/19
Ethics committee reference number
IR.QUMS.REC.1396.188
Health conditions studied
1
Description of health condition studied
Generalized moderate chronic periodontitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Level of pentraxin-3 in gingival crevicular fluid
Timepoint
At the beginning of the study and 6 weeks after scaling and rootplaning
Method of measurement
enzyme-linked immunosorbent assay
Secondary outcomes
empty
Intervention groups
1
Description
Control group: receive no treatment.
Category
Diagnosis
2
Description
Participants receive oral hygiene instructions (the rolling method twice a day) .Phase I periodontal therapy is performed for periodontitis patients in two sessions with a one-week interval, and includes scaling and root planing with hand and ultrasonic instruments. No antibiotic or anti-inflammatory agent is prescribed for patients. Periodontitis patients are recalled six weeks after the second treatment session. Gingival crevicular fluid is collected again from the same area and clinical parameters are measured again. All procedures will be performed by the same operator . The patients are recalled two weeks after the second scaling session and their adherence to oral hygiene instructions is evaluated. Supragingival prophylaxis is also performed for them . Gingival crevicular fluid is collected using Periopaper . Paper strip is inserted into the gingival crevice and remained there for one minute.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontology department of Qazvin University of Medical Sciences
Full name of responsible person
Mahtab Samieifar
Street address
Qazvin University of Medical Sciences, Bahonar Blvd,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3335 3061
Email
m.samieifar@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Qazvin University of Medical Sciences, Bahonar Blvd,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3335 3061
Fax
+98 28 3335 3066
Email
dentistry@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Mahtab Samieifar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 19 , Sadaf alley, North ferdosi Ave, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3413885400
Phone
+98 28 3335 1408
Fax
Email
m.samieifar@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahtab Samieifar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 19 , Sadaf alley, North ferdosi Ave, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3413885400
Phone
+98 28 3335 1408
Fax
Email
m.samieifar@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahtab Samieifar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 19 , Sadaf alley, North ferdosi Ave, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3413885400
Phone
+98 28 3335 1408
Fax
Email
m.samieifar@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD