Aim of this study is evaluating the effect of periodontal bandages and tissue sticks in impacted teeth operation. Patients are between 13-30 years old that are clinically healthy and have an impacted tooth in upper jaw palate. They enter the study and undergo exposing operation for the impacted tooth then they are divided into two groups in one periodontal bandage is applied for one week while in the other one tissue stick is applied for the same period of time. Before applying the packs a photo is taken from the area and also a pain and bleeding questionnaire is handed out to the patient. The patient is called out after a week, the periodontal pack is removed and again another photo is taken from the area then the two photos are compared in size before and after applying the packs in a software. They wound is also evaluated for bleeding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701079002N6
Registration date:2017-09-10, 1396/06/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-10, 1396/06/19
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
Hamedan of University of Medical Sciences Vice chancellor of research
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of periodontal bandages and cyanoacrylate tissue stick on palatally impacted teeth gingiva after exposure operation
Public title
Evaluating the effect of periodontal bandages on impacted teeth gingiva after exposure operation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Normal periodontal status; Age range between 13-30 years; Systemic health; Not taking anti coagulating drugs; Not having craniofacial anomalies such as lip and palate cleft; Operation procedure carried out properly and during the operation incidents like over bleeding or laceration does not happen; Open operation
Exclusion criteria: Having chronic or aggressive periodontal diseases; Having craniofacial anomalies like lip and palate cleft; Having systemic diseases including diabetes and coagulating problems; Smoking; History of gingival operation from palatal tissue
Age
From 13 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Type of study is simple randomized. Patients referred were listed and then put into randomized number tables and later divided into two groups by spss software
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan university of medical sciences
Street address
Hamedan university of medical sciences, park intersection, hamedan, Iran
City
Hamedan
Postal code
Iran
Approval date
2017-02-18, 1395/11/30
Ethics committee reference number
ir.umsha.rec.1395.561
Health conditions studied
1
Description of health condition studied
Palatally impacted teeth
ICD-10 code
ko1.1
ICD-10 code description
An impacted tooth is a tooth that has failed to erupt because of obstruction by another tooth.
Primary outcomes
1
Description
The exposed field size
Timepoint
Before interference and one week after interference
Method of measurement
By image J application
Secondary outcomes
1
Description
Pain
Timepoint
Before interference and one week after interference
Method of measurement
Questionnaire
2
Description
Bleeding
Timepoint
Before interference and one week after interference
Method of measurement
Questionnaire
Intervention groups
1
Description
Applying tissue stick after the exposing operation
Category
Treatment - Surgery
2
Description
Applying periodontal bandageafter the exposing operation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontics ward at dentistry faculty of Hamedan university
Full name of responsible person
Street address
Dentistry faculty of hamedan univeristy of medical sciences, Pazhuhesh intersection, Hamedan, Iran
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Hamedan University of Medical Sciences
Full name of responsible person
Vice chancellor for research Hamedan University of Medical Sciences
Street address
Chancellor of researcher and technology, hamedan university of medical sciences, Mahdie street, Shariati street, Hamedan, Iran
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Hamedan 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
Hamedan of University of Medical Sciences
Full name of responsible person
said bashirian
Position
Chancellor of research
Other areas of specialty/work
Street address
Chancellor of researcher and technology, hamedan university of medical sciences, Mahdie street, Shariati street, Hamedan, Iran
City
Hamedan
Postal code
Phone
+98 81 3838 0717
Fax
Email
s_bashirian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan university of medical sciences
Full name of responsible person
Sara Soheilifar
Position
University professor
Other areas of specialty/work
Street address
Dentistry faculty, Hamedan
City
Hamedan
Postal code
Phone
+98 918 316 1503
Fax
Email
sara.soheilifar@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Sara Soheilifar
Position
University professor, specilaist
Other areas of specialty/work
Street address
Dentistry faculty, Hamedan
City
Hamedan
Postal code
Phone
+98 983 161 503
Fax
Email
sara.sohilifar@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)