Objective: The purpose of this study is to investigate the effect of Coe-Pak periodontal dressing on the pain and microbial contamination of suture after modified widman flap surgery in patients with chronic periodontitis. Design: This study has a randomized, not blinded, with control group and single-center design. Major inclusion criteria: chronic periodontitis disease; age over 18 years; not having systemic disease; no periodontal treatment in the last six months. Major exclusion criteria: other treatments for periodontal disease during the study period. Study population: patients with chronic periodontitis disease. Sample size: 23 patients. Interventions: Use of Coe-Pak periodontal dressing in the interventions group; No use of any periodontal dressing in the control group. Intervention time: 22.11.2010. Main Outcome Measures: changes in pain and microbial contamination of suture after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504114877N26
Registration date:2015-10-02, 1394/07/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-02, 1394/07/10
Registrant information
Name
Jaber Yaghini
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 1434 2136
Email address
j_yaghini@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Isfahan University of Medical Sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial Study of Coe-Pak Dressing effect on Pain and Microbial Contamination of Suture after Surgery in Patients with Chronic Periodontitis
Public title
Effect of Coe-Pak Dressing on the Side Effects of Periodontal Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with chronic periodontitis disease which require modified widman flap surgery in two quadrants; age over 18 years; lack of systemic disease; no pregnancy; no previous periodontal treatment and systemic antibiotics therapy in the last 6 months; not being smoker.
Exclusion criteria: the patient’s unwillingness to continue the treatment; being under other treatment and taking medications which may affect the result during the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A coin tossing is used for Randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jerib St, Isfahan, Iran.
City
Isfahan
Postal code
Approval date
2010-06-21, 1389/03/31
Ethics committee reference number
389157
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
Severity of pain after surgery
Timepoint
1 week after the surgery
Method of measurement
Visual analog scale questionnaire
2
Description
Number of bacterial colonies of sutures after surgery
Timepoint
1 week after the surgery
Method of measurement
McFarland technique with colony- forming units per milliliter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after mixing the equal length of two paste (accelerator paste and base paste), Surgical flaps were covered with uniform pink color of Coe-Pak periodontal dressing (GC Company, America). Composition: fatty acids, natural and synthetic rosin, mineral oil, vegetable oil, zinc oxide, magnesium oxide
Category
Treatment - Other
2
Description
Control group: Surgical flaps were not covered with any periodontal dressing.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Street address
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Omid Savabi
Street address
Vice Chancellor of Research, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Isfahan 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
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant professor
Other areas of specialty/work
Street address
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Postal code
8174673461
Phone
+98 317922825
Fax
Email
j_yaghini@dnt.mui.ac.ir.
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant professor
Other areas of specialty/work
Street address
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Postal code
8174673461
Phone
+98 317922825
Fax
Email
j_yaghini@dnt.mui.ac.ir.
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant professor
Other areas of specialty/work
Street address
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Postal code
8174673461
Phone
+98 317922825
Fax
Email
j_yaghini@dnt.mui.ac.ir.
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)