To assess the effect of phase I periodontal treatment on the quality of life of patients with moderate to severe periodontitis
Design
This is a before-after clinical trial, in which 60 eligible patients will be enrolled in the study.
Settings and conduct
The eligible patients with moderate to severe periodontitis referring to the School of Dentistry in Hamadan city during the study period will be enrolled in the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Chronic moderate to severe periodontitis,
Moderate to severe gingivitis,
CAL equal to or greater than 3 ml,
Exclusion criteria:
Systemic or metabolic diseases,
Indication of surgery,
Pregnancy or breastfeeding
Intervention groups
Intervention group:
Phase 1 periodontal treatment including scaling and root leveling plus chlorhexidine mouthwash twice a day for a week
Main outcome variables
Primary outcome:
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N370
Registration date:2020-10-05, 1399/07/14
Registration timing:retrospective
Last update:2020-10-05, 1399/07/14
Update count:0
Registration date
2020-10-05, 1399/07/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of phase I periodontal treatment on the quality of life of patients with moderate to severe periodontitis: a before-after clinical trial
Public title
Effect of phase I periodontal treatment on the quality of life of patients with moderate to severe periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Chronic moderate to severe periodontitis,
Moderate to severe gingivitis,
CAL equal to or greater than 3 ml,
Exclusion criteria:
Systemic or metabolic diseases,
Indication of surgery,
Pregnancy or breastfeeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-06-27, 1399/04/07
Ethics committee reference number
IR.UMSHA.REC.1399.325
Health conditions studied
1
Description of health condition studied
Moderate to severe periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and one week later
Method of measurement
Using Standard Quality of Life (QoL) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Phase 1 periodontal treatment including scaling and root leveling plus chlorhexidine mouthwash twice a day for a week
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Dr Maryam Purjebreil
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dr.purjebreil@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Maryam Purjebreil
Position
Resident of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dr.purjebreil@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Leila Gholami
Position
Periodontist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Fax
Email
l.gholami@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
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