Background: Patient-based outcome is an important aspect of periodontal treatments. Information on patients' quality of life after periodontal treatment is limited.
Aim: This is a quasi-experimental interventional study aiming at determining the patient perception of oral health and the impact that non-surgical and surgical periodontal therapy have on their quality of life.
40 patients with moderate to advanced chronic periodontitis will be recruited to participate in this study. Subjects are from those who visit a private clinic for the diagnosis and treatment of periodontitis. All the patients sign an informed consent upon entry. At baseline and after non-surgical and surgical treatment, periodontal parameters comprised of pocket depth, clinical attachment level, and bleeding on probing will be recorded by a blind examiner. Periodontal non-surgical treatment is comprised of one-stage full mouth disinfection (Quirynen 1995). Surgical treatment involves quadrant-based open flap debridement with minor osseous surgery. Patients will complete the Iranian version of the Oral Health Impact Profile (OHIP) questionnaire (OHIP-35 after validation), at three stages: baseline, one week post-initial therapy, and after completion of periodontal surgical phase. Data will be analyzed using repeated measure ANOVA, paired and independent t-tests, and Green house-Geisser by SPSS software version 21.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709211081N8
Registration date:2017-10-02, 1396/07/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-02, 1396/07/10
Registrant information
Name
Golpar Radafshar
Name of organization / entity
Guilan University of Medical Sciences, School of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 0775
Email address
golshad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
This is a self-funding research.
Expected recruitment start date
2017-10-15, 1396/07/23
Expected recruitment end date
2018-08-15, 1397/05/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of one-stage full mouth disinfection versus periodontal surgery on oral health-related quality of life in patients with chronic periodontitis
Public title
How periodontal treatment affects oral health-related quality of life in patients with chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were a diagnosis of generalized moderate to severe chronic periodontitis and having at least 20 standing teeth. The exclusion criteria were a history of periodontal treatment 6 months prior to entry, taking any medication known to affect periodontal tissues, taking anti-depressant, anti-anxiety, anti-inflammatory, and immunosuppressive medications, uncontrolled diabetes, pregnancy or lactation, smoking, and needing antibiotic prophylaxis.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The original OHIP-49 questionnaire was validated and standardized for Iranian population using CVI and CVR. Some questions did not meet the appropriate CVI or CVR and were deleted. The resultant questionnaire with 35 items was used in this study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
School of health old building, opposite 17 Shahrivar hospital, Siadati street, Namjoo road
City
Rasht
Postal code
Approval date
2016-01-26, 1394/11/06
Ethics committee reference number
IR.GUMS.REC.1394.395
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Oral health-related quality of life
Timepoint
Baseline, after non-surgical, after surgical intervention
Method of measurement
Validated Iranian version of the Oral health impact profile questionnaire
Secondary outcomes
1
Description
Periodontal pocket depth
Timepoint
Baseline, after non-surgical, after surgical interventions
Method of measurement
Using a periodontal probe, distance from gingival margin to the base of the pocket is measured
2
Description
Clinical attachment level
Timepoint
Baseline, after non-surgical, after surgical interventions
Method of measurement
Using a periodontal probe, distance from a fix point to the base of pocket is measured
3
Description
Bleeding on probing
Timepoint
Baseline, after non-surgical, after surgical interventions
Method of measurement
Lenox & Kopczyk bleeding index
Intervention groups
1
Description
Non-surgical periodontal treatment based on Quirynen protocol of one stage full mouth disinfection comprised of scaling and root planing with Chx 0.2% pocket irrigation completed within 24 hours.
Category
Treatment - Other
2
Description
Surgery comprised of flap debridement with minor osseous surgery on a quadrant basis over single or multiple treatment episodes, according patient’s treatment needs. In case of multiple sessions, a minimum of 2-week interval was considered.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Golpar Radafshar's private clinic
Full name of responsible person
Dr. Golpar Radafshar
Street address
7th floor, Pasteur Medical Building, Golsar intersection
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Private clinic, Dr. Golpar Radafshar, associate professor of periodontology, Guilan University of Me
Full name of responsible person
Dr. Golpar Radafshar
Street address
7th floor, Pasteur Medical Building, Golsar Intersection
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private clinic, Dr. Golpar Radafshar, associate professor of periodontology, Guilan University of Me
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dental Sciences Research Center, Dental Faculty, Guilan University of Medical Sciences
Full name of responsible person
Nastaran Mirfarhadi
Position
MS in nursing education
Other areas of specialty/work
Street address
Guilan University of Medical Sciences complex, Professor Samiee Blv. Gaz square
City
Rasht
Postal code
4194173774
Phone
+98 13 3326 3616
Fax
Email
mirfarhadin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Periodontology, Dental Faculty, Guilan University of Medical Sciences
Full name of responsible person
Dr. Golpar Radafshar
Position
Associate Professor of periodontology
Other areas of specialty/work
Street address
Guilan University of Medical Sciences complex, Professor Samiee Blv. Gaz square
City
rasht
Postal code
4194173774
Phone
+98 13 3326 3616
Fax
Email
golshad@gums.ac.ir/ or/ golishad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Periodontology, Dental Faculty, Guilan University of Medical Sciences
Full name of responsible person
Dr. Golpar Radafshar
Position
Associate professor of periodontoloty
Other areas of specialty/work
Street address
Guilan University of Medical Sciences complex, Professor Samiee Blv. Gaz square
City
Rasht
Postal code
4194173774
Phone
+98 13 3326 3616
Fax
Email
golshad@gums.ac.ir /or/ golishad@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)