Surgical site after periodontal surgeries are prone to infection or superficial traumas, so in most cases the surgical site is covered by periodontal dressing. This study will be conducted to compare two periodontal dressings Coe-pak and new experimental sample (a product under development), following periodontal surgery. In this double blind randomized study, 24 patients with adult chronic peridontitis will be recruited. The dressings are applied by a single operator and both patients and operator assistant are blind to dressing type. The dressing has no therapeutic effect but protects underlying tissue and accelerates healing process and prevents pain, bleeding and perforation or rapture of gums. The outcome of the study is tissues healing; handling properties, subjective assessment, and a 7-day post operative assessment of the surgical sites will be performed and compared in study groups.
General information
Acronym
Design and formulation of periodontal dressing
IRCT registration information
IRCT registration number:IRCT201104131606N6
Registration date:2011-05-26, 1390/03/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-26, 1390/03/05
Registrant information
Name
Jalaleddin Hamissi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 3064
Email address
jhamissi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Azad University Of Tehran
Expected recruitment start date
2011-03-04, 1389/12/13
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and formulation of periodontal dressing and invivo assesment incompare with Coe-pak
Public title
Design and formulation of periodontal dressing and invivo assesment incompare with Coe-pak
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Aage between 35- 60 years with periodontal disease.
Exclusion criteria: Pregnancy. breast feeding, bleeding and perforation or rapture of gums
Age
From 35 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy for Research Azad University of Tehran
Street address
Shariati st.
City
Tehran
Postal code
Approval date
2011-03-03, 1389/12/12
Ethics committee reference number
15036
Health conditions studied
1
Description of health condition studied
Periodontal desease
ICD-10 code
k05.2
ICD-10 code description
Acute periodontitis
Primary outcomes
1
Description
Tssues healing
Timepoint
Daily
Method of measurement
Examination by periodontist
Secondary outcomes
empty
Intervention groups
1
Description
Control group: using co-pack after surgery
Category
Treatment - Drugs
2
Description
Intervention group: using new formulation after surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental disease clinic, Qazvin University of Medical Sciences
Full name of responsible person
J Hamissi
Street address
Blv Shahid ba honar
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Azad University of Tehran
Full name of responsible person
Deputy for research
Street address
Azad University of Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad University of Tehran
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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Jalal Hamissi
Position
Assistant professor
Other areas of specialty/work
Street address
Bvl Shahid ba honar
City
Qazvin
Postal code
Phone
+98 28 1335 3067
Fax
Email
jhamissi@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Jalal Hamissi
Position
Assistant professor
Other areas of specialty/work
Street address
Bvl Shahid ba honar
City
Qazvin
Postal code
Phone
+98 28 1335 3067
Fax
Email
jhamissi@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Jalal Hamissi
Position
Assistant Professor
Other areas of specialty/work
Street address
Blv: Shahid ba honar
City
Qazvin
Postal code
Phone
+98 28 1335 3066
Fax
Email
jhamissi@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)