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Evaluation of effect of propolis on palatal wound healing and pain management following harvesting free gingival graft

Protocol summary

Summary
The aim of this study is to evaluate the effect of propolis on palatal wound healing and pain management following harvesting free gingival graft. For this double-blind randomized clinical trial, 10 patients who required bilateral free gingival graft are selected. Following the surgery in control area, propolis-free oral ointment containing pectin, paraffin and carboxy methyl cellulose is applied over the palatal wound and the wound in the test area is protected by oral ointment containing 3.6 % propolis.The patient and the operator aren't informed about the type of the ointment. Level of pain and burning sensation are recorded on 1st, 3rd, 7th, 14th and 21st days following the surgery. Number of pain killers consumed and number of days patients take the pain killers are asked on 21st day. Bleeding in palatal area is evaluated on 7th, 14th, and 21st days. Dimensional changes and color match values are evaluated via photographs which are taken at baseline and 7th, 14th, 21st , 30th, 42nd days from palatal wound area. Dimensional changes are evaluated with AutoCAD software and predetermined scale. Color coordination of donor site and adjacent normal tissues are evaluated using Photoshop software. The thickness of the donor site is measured using a sterile kfile #15 on 4 sites of wound area at baseline and 30th, 42nd days and the mean value is recorded. The data between test and control groups will be compared by statistical analysis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015073123425N1
Registration date: 2015-09-01, 1394/06/10
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-01, 1394/06/10
Registrant information
Name
Zahra Alizadeh Tabari
Name of organization / entity
Qazvin University of Medical Sciences, Qazvin Dental School
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 3062
Email address
drz.alizadeh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2015-10-20, 1394/07/28
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of propolis on palatal wound healing and pain management following harvesting free gingival graft
Public title
Effect of propolis on palatal wound healing and pain management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: no systemic disease interfere with the wound healing, no cigarette smoking, no allergy to honey Exclusion criteria: patients without cooperation during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Qazvin Dental School, Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin, Iran
City
Qazvin
Postal code
Approval date
2015-07-12, 1394/04/21
Ethics committee reference number
IR.QUMS.REC.1394.80, IR.QUMS.REC.1394.79

Health conditions studied

1

Description of health condition studied
gingival graft due to lack of attached gingiva
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain level
Timepoint
on 1st, 3rd, 7th, 14th and 21st days following the surgery
Method of measurement
visual analogue scale

2

Description
dimensional changes
Timepoint
7th, 14th, 21st , 30th, 42nd days
Method of measurement
Dimensional changes are evaluated via photographs which are taken at baseline and 7th, 14th, 21st , 30th, 42nd days from palatal wound area. Dimensional changes are evaluated with AutoCAD software and predetermined scale.

3

Description
thickness of palatal donor site
Timepoint
0, 30th and 42nd days
Method of measurement
measured using a sterile kfile #15 on 4 sites of wound area at baseline and 30th, 42nd days and the mean value is recorded.

4

Description
color match
Timepoint
7th, 14th, 21st , 30th, 42nd days
Method of measurement
Color coordination of donor site and adjacent normal tissues are evaluated using Photoshop software.

Secondary outcomes

1

Description
burning sensation
Timepoint
on 1st, 3rd, 7th, 14th and 21st days
Method of measurement
by asking patients, yes or no

2

Description
Number of pain killers consumed
Timepoint
21st day
Method of measurement
by asking patients

3

Description
number of days patients take the pain killers
Timepoint
on 21st day
Method of measurement
by asking patient

4

Description
bleeding of the wound
Timepoint
on 7th, 14th, and 21st days.
Method of measurement
by rubbing the gauze on the wound/ yes or no

Intervention groups

1

Description
in control area, propolis-free oral ointment containing pectin, paraffin and carboxy methyl cellulose is applied over the palatal wound
Category
Treatment - Drugs

2

Description
in the test area is protected by oral ointment containing 3.6 % propolis.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Alizadeh Tabari
Street address
Qazvin Dental School, Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin, Iran
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Alizadeh Tabari
Street address
Qazvin Dental School, Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin, Iran
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Farzaneh Dashkhaneh
Position
dental student
Other areas of specialty/work
Street address
Qazvin Dental School, Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 3335 3064
Fax
Email
farzaneh.d92@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Alizadeh Tabari
Position
Assistant Professor
Other areas of specialty/work
Street address
Qazvin Dental School, Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 3335 3064
Fax
Email
drz.alizadeh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Alizadeh Tabari
Position
Assistant Professor
Other areas of specialty/work
Street address
Qazvin Dental School, Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin, Iran
City
Qazvin
Postal code
Phone
Fax
Email
drz.alizadeh@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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