Protocol summary

Summary
The aim of this single randomized clinical trial study was to determine the effect of dressing on wound healing and patient satisfaction after periodontal flap surgery. This study was conducted on patients who in the treatment plan at least two areas on either side of a jaw surgery was planned. Information included: pain, bleeding, inflammation, swelling, color and granulation tissue of the gum and easily feed patients. Inclusion criteria were the extent of the disease in the region around (in terms of clinical and radiographic) was similar and required same surgery were similar in the two areas. Exclusion criteria included the use of antibiotics, corticosteroids, and hormone during the past two months, diabetes, smoking and impaired repair or physically weak after the first surgery. A total of 33 patients admitted to the Hamadan school of dentistry was studied. In half of patients periodontal pack was used and the used pack was removed a week after surgery. On the 7 and 14 days after surgery, the patients surveyed by the examiner and the clinical symptoms (including color, consistency and presence of granulation tissue) examined.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201211139002N3
Registration date: 2013-01-28, 1391/11/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-28, 1391/11/09
Registrant information
Name
Sara Soheilifar
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1824 7998
Email address
sara.soheilifar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental faculty of Hamadan University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-09-06, 1391/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of periodontal dressing on wound healing and patient satisfaction after periodontal flap surgery
Public title
The effect of periodontal pack on periodontal flap surgery results
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: same clinical and radiographic disease distribution in both sides of a jaw exclusion criteria: Under antibiotic,corticosteroid or hormonal drugs during the last 2 months diabetes; smoking; disturbed healing process after the first surgery
Age
From 22 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 33
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
Hamedan university of medical science
Street address
Opposite of Luna park, Shahid Fahmideh St, Hamadan
City
Hamedan
Postal code
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
3493/9/35/16/پ/د

Health conditions studied

1

Description of health condition studied
flap surgery
ICD-10 code
K05.5
ICD-10 code description
Other periodontal diseases

Primary outcomes

1

Description
gingival color
Timepoint
7 and 14 days after surgery
Method of measurement
visual

2

Description
Consistency of gingiva
Timepoint
7 and 14 days after surgery
Method of measurement
periodontal probe

3

Description
patient pain
Timepoint
To three days after surgery
Method of measurement
Visual scale of pain

4

Description
comfort of nutrition
Timepoint
To three days after surgery
Method of measurement
Questionnaire

5

Description
patient satisfaction
Timepoint
7 and 14 days after surgery
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Periodontal pack intervention group: We bring the pack in the form of two roll bars, almost as the size of treated area length. we bring the end of one of the bars in the form of loop and twist on the surface of distal last tooth. then we drag the remaining of this bar along the surface of distal tooth into midline and press that along gingival and Interproximal margin slowly. the second bar is placed in lingual surface. used pack is removed a week after surgery.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental faculty of Hamadan University of Medical Sciences
Full name of responsible person
Mehri jafari
Street address
Opposite of Luna park, Shahid Fahmideh St., Hamadan
City
hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Medical faculty of Hamadan University of Medical Sciences
Full name of responsible person
Maryam Asgari
Street address
Opposite of Luna park, Shahid Fahmideh St., Hamadan University of Medical Sciences, Medical faculty
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical faculty of Hamadan 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
Dental faculty of Hamadan University of Medical Sciences
Full name of responsible person
Mehri Jafari
Position
Student of dentistry
Other areas of specialty/work
Street address
Opposite of Luna park, Shahid Fahmideh St., Hamadan
City
Hamadan
Postal code
Phone
+98 81 1835 4017
Fax
Email
mehri1367@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental faculty of Hamadan University of Medical Sciences
Full name of responsible person
Sara soheilifar
Position
Assisstant professor
Other areas of specialty/work
Street address
Opposite of Luna park, Shahid Fahmideh St., Hamadan
City
Hamadan
Postal code
Phone
+98 81 1835 4017
Fax
Email
sara.soheilifar@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dental faculty of Hamadan University of Medical Sciences
Full name of responsible person
Mehri jafari
Position
Student of dentistry
Other areas of specialty/work
Street address
Opposite of Luna park, Shahid Fahmideh St., Hamadan
City
Hamadan
Postal code
Phone
+98 81 1835 4017
Fax
Email
mehri1367@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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