The effectiveness of honey mucoadhesive in the gingival healing process and reducing pain after a single blind ginivectomy
Inclusion criteria: People must be suffering from chronic inflammatory gingival enlargement and need ginivectomy at at least two areas that are the same or have melanin hyperpigmentation;There would be no periodontal attachment loss; The number of teeth that are involved in volume increment should be less than or equal to 6.; There would be no evidence of the need to surgical correction of bones and there should be left at least 3 mm gingival after surgery.
Exclusion criteria:Smokers; Pregnant Women; People with diseases that affect the wound healing such as: diabetic; People who receive corticosteroids; People who receive immunosuppressive drugs; Patients allergic to honey
(A) Study population: 17 patients 15-45 years old referring to Periodontics department of Dentistry School , Zahedan Medical Sciences University -1395
(B) intervention group using replacement surgery mucoadhesive mucoadhesive honey on the first and third days after surgery control group not use of mucoadhesive honey
(C) First and third days after surgery
(D) Primary outcome: wound healing, pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050327726N1
Registration date:2016-06-21, 1395/04/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-21, 1395/04/01
Registrant information
Name
Majid Shojaei
Name of organization / entity
Zahedan Medical Science University
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 4003
Email address
majid.shojaei@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-07-05, 1395/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of honey mucoadhesive on gingiva wound healing and pain after gingivectomy
Public title
The effect of honey on gingiva wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: People must be suffering from chronic inflammatory gingival enlargement and need ginivectomy at at least two areas that are the same or have melanin hyperpigmentation;There would be no periodontal attachment loss; The number of teeth that are involved in volume increment should be less than or equal to 6.; There would be no evidence of the need to surgical correction of bones and there should be left at least 3 mm gingival after surgery.
Exclusion criteria:Smokers; Pregnant Women; People with diseases that affect the wound healing such as: diabetic; People who receive corticosteroids; People who receive immunosuppressive drugs; Patients allergic to honey
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
17
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Dr. Hesabi Sq.
City
Zahedan
Postal code
9816743463
Approval date
2016-05-01, 1395/02/12
Ethics committee reference number
ir.zaums.rec.1395.46
Health conditions studied
1
Description of health condition studied
Gingival hyperpigmentation
ICD-10 code
K05.6
ICD-10 code description
Periodontal disease, unspecified
Primary outcomes
1
Description
Wound healing
Timepoint
One day, three days, seven days
Method of measurement
Visual - Observation
2
Description
Pain
Timepoint
Two hours, six hours, twelve hours
Method of measurement
VAS Scale
Secondary outcomes
1
Description
The color of gingival
Timepoint
One day, three days, seven days
Method of measurement
Visual, observation
Intervention groups
1
Description
control group not using mucoadhesive honey
Category
N/A
2
Description
intervention group using replacement surgery mucoadhesive mucoadhesive honey on the first and third days after surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Zahedan university of Medical Sciences
Full name of responsible person
Dr. Parvin Arbabi Kalati, Periodantics, University Professor
Street address
School of Dentistry, Zahedan university of Medical Sciencesl, Azadegan Sharqi Ave,
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Zahedan University of Medical Sciences
Full name of responsible person
Dr. Houshang Rafiqdoust
Street address
Zahedan university of medical science, Dr. Hesabi Sq.
City
Zahedan
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 and Technology Zahedan 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, Zahedan university of Medical Sciences
Full name of responsible person
Dr. Parvin Arbabi Kalati
Position
Periodantics, University Professor
Other areas of specialty/work
Street address
Zahedan Dental School, Azadegan Sharqi,
City
Zahedan
Postal code
9817699693
Phone
+98 54 3241 4001
Fax
+98 54 3241 4001
Email
arbabi.parvin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry, Zahedan university of Medical Sciences
Full name of responsible person
Dr. Parvin Arbabi Kalati
Position
Periodantics
Other areas of specialty/work
Street address
Zahedan Dental School, Azadegan Sharqi Ave,
City
Zahedan
Postal code
9817699693
Phone
+98 54 3241 4001
Fax
+98 54 3241 4001
Email
arbabi.parvin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan Dental School
Full name of responsible person
Dr. Parvin Arbabi Kalati
Position
Periodantics
Other areas of specialty/work
Street address
School of Dentistry, Zahedan university of Medical Sciences, Azadegan Sharqi Ave,
City
Zahedan
Postal code
9817699693
Phone
+98 54 3241 4001
Fax
+98 54 3241 4001
Email
arbabi.parvin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)