The objective of this study was to investigate the clinical effect of debridement with combination of PVP-I10% and H2O2 3% in the treatment of moderate to severe chronic periodontitis. (PVP-I: povidone iodine, H2O2: hydrogen peroxide, SRP: scaling & root planning). Sixteen patients (both sexes aged 30-56 years) who had a total of 64 periodontal pockets with depth more than 5 mm were recruited. Periodontal pockets of 4 quadrants in each patient were randomly assigned to one of the following treatment modalities: SRP + subgingival irrigation with PVP-I 10%, SRP + subgingival irrigation with H2O2 3% , SRP + subgingival irrigation with combination of PVP-I 10% and H2O2 3%, SRP + subgingival irrigation with normal saline (control). Depth of periodontal pocket was measured 5 weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902043785N1
Registration date:2008-04-05, 1387/01/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2008-04-05, 1387/01/17
Registrant information
Name
Fateme Koohpeima
Name of organization / entity
Dental school, Shirz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 716 1939
Email address
fkoohpeima@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Shieaz University of Medical Sciences
Expected recruitment start date
2008-04-05, 1387/01/17
Expected recruitment end date
2008-05-06, 1387/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical effect of debridement with combination of PVP-I10% and H2O2 3% in the treatment of moderate to severe chronic periodontitis.
Public title
The clinical effect of debridement with combination of PVP-I10% and H2O2 3% in the treatment of moderate to severe chronic periodontitis.
Purpose
Prevention
Inclusion/Exclusion criteria
Exclusion criteria: Iodine sensitivity, presence of thyroid disease, need to antibiotic prophylaxis, SRP in 3 previous months, pregnancy, medical problems that intervene with the study
Age
From 30 years old to 56 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
---
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Postal code
ct-87-4005
Approval date
empty
Ethics committee reference number
ct-87-4005
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
periodontal pocket depth
Timepoint
5 weeks after treatment
Method of measurement
With periodontal probe
Secondary outcomes
1
Description
Improvement in periodontal status
Timepoint
6 months after treatment
Method of measurement
Periodontal probe
Intervention groups
1
Description
Insertion of PVP-I 10% in perio pocket with insulin syringe for 5 min.
Category
Treatment - Drugs
2
Description
Insertion of the combination of PVP-I 10% and H2O2 3% in perio pocket with insulin syringe for 5 min.
Category
Treatment - Drugs
3
Description
Insertion of the combination of PVP-I 10% and H2O2 3% in perio pocket with insulin syringe for 5 min.
Category
Treatment - Drugs
4
Description
Insertion of normal saline (sodium chloride 0.9%) in perio pocket with insulin syringe for 5 min.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Dental School
Full name of responsible person
Fateme Koohpeima
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Center of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Dabbaghmanesh
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz,
City
Shiraz
Grant name
---
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center of Shiraz University of Medical Sciences
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
Shiraz Dental School
Full name of responsible person
Fateme Koohpeima
Position
Resident
Other areas of specialty/work
Street address
periodontal department, Shiraz Dental School
City
Shiraz
Postal code
1234
Phone
+98 71 1627 5781
Fax
+98 71 1627 5781
Email
koohpeima.f@gmaile.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Fateme Koohpeima
Position
Resident of Restorative dentistry
Other areas of specialty/work
Street address
Golestan dormitory, Chamran boulevard, Shiraz
City
Shiraz
Postal code
1234
Phone
+98 71 1627 5781
Fax
+98 71 1627 5781
Email
koohpeima.f@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)