The main purpose of the study is determinating the efficacy of Bromelain on donor wound healing after free gingival surgery that will do according to a randomized , double blind and placebo-controlled study.
Study population: Individuals who refer to treatment of gingival recession in the anterior site of the mandible that candidate to free gingival graft surgery and have thease criteria will choose:
-One of the mandibullar central incisor has Miller class 1,2 or 3 gingival recession.
-Systemically healthy
-Don't use anticoagulatory drugs like Warfarin.
- Didn't use antibiotic and corticosteroid at least during the past tow months.
-Aren't smoker or don't smoke more than 10 cigarette.
-The mesdames aren't pregnant or lactiferrous .
The sample size determined on the basis of preliminary sampling is 26 subjects.
For the intervention group, 500 mg once daily Bromelain will be used on the day of surgery and continued for ten days and to the control group,placebo will give.
7 days after surgery,variables( pain, bleeding, and epithelialization of donor site) will survey on the basis of a questionnaire that will be completed by a third person who is unaware of the group of patients.
Pain is directly based on VAS and the indirect method based on the number of analgesic tablets will be tested.
Evaluatation of epithelialization , will be repeated 10 days after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502089002N5
Registration date:2015-03-15, 1393/12/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-15, 1393/12/24
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 University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-04-09, 1394/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of Bromelain on donor wound healing after free gingival surgery
Public title
Evaluating the efficacy of Bromelain on donor wound healing after free gingival surgery
Purpose
Supportive
Inclusion/Exclusion criteria
In this study , individuals who refer to treatment of gingival recession in the anterior site of the mandible that candidate to free gingival graft surgery and have thease criteria will choose:
-One of the mandibullar central incisor has Miller class 1,2 or 3 gingival recession.
-Systemically healthy
-Don't use anticoagulatory drugs like Warfarin.
- Didn't use antibiotic and corticosteroid at least during the past tow months.
-Aren't smoker or don't smoke more than 10 cigarette.
-The mesdames aren't pregnant or lactiferrous .
To evaluate of epithelialization, 3% hydrogen peroxide apply to the wound by a brush. If the epithelialization is completed, then hydrogen peroxide dose not diffuse into the connective tissue, and oxygen is not librated, ther for any bubble dose not observe.Otherwise , the epithelialization isn't completed.
2
Description
pain
Timepoint
7 days after surgery
Method of measurement
VAS
3
Description
the number of analgesic tablets that take by the patients
Timepoint
7 days after surgery
Method of measurement
the number that reported by the patients
Secondary outcomes
1
Description
bleeding
Timepoint
7 days after surgery
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group : Bromelain (capsule 500mg, oral , once a day for 10 days )
Category
Treatment - Drugs
2
Description
Control group : placebo (capsul , oral , once a day for 10 days )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology, School of Dentistry
Full name of responsible person
Sara Soheilifar
Street address
Shahid Fahmide Street
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hamid Reza Abdosamadi
Street address
Shahid Fahmide Street
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
School of dentistry
Full name of responsible person
Fahime khoshkhooie
Position
student
Other areas of specialty/work
Street address
Shahid Fahmide Street
City
Hamedan
Postal code
Phone
+98 81 3838 0572
Fax
Email
fahime_khoshkhooie68@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
school of dentistry of Hamedan
Full name of responsible person
Sara Soheilifar
Position
Specialist in Periodontics
Other areas of specialty/work
Street address
Shahid Fahmide Street
City
Hamedan
Postal code
Phone
+98 81 3838 0572
Fax
Email
sara.soheilifar@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
school of dentistry
Full name of responsible person
Fahime khoshkhooie
Position
student
Other areas of specialty/work
Street address
Shahid Fahmide Street
City
Hamedan
Postal code
Phone
+98 81 3838 0572
Fax
Email
fahime_khoshkhooie68@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)