Evaluation of the effect of licorice gel on pain and wound healing in the hard palate
Design
A randomized, blinded, controlled clinical trial with a parallel group design, phase 3 on 12 patients.
Settings and conduct
This study is a randomized and double-blind controlled clinical trial (therapist and patients will not know which tube is placebo, and the pharmacist will deliver the tubes to the therapist in the same color and shape and numbered 1 and 2) and split mouth after Getting approval from the ethics committee will be done on 12 patients who are candidates for gum transplant in the periodontology department of Shiraz University of Medical Sciences, Faculty of Dentistry. In all selected patients, the test drug (gel containing licorice plant extract) will be placed on one side and the placebo drug will be placed on the other side by a sterile clean ear. The choice of test or control surgery will be done completely randomly. All surgeries will be performed by one surgeon and at an interval of one month for each patient. On the test side, the patients will be given a gel containing licorice plant extract (10%) twice a day for 7 days in the wound area. apply and the patients are advised not to eat anything for an hour after using the gel. After about a month, the other side will be operated and the patients are advised to use the placebo gel.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients in need of bilateral free gingival graft
Age between 18_60 years
Exclusion criteria:
Diabetic patients
Patients with uncontrolled blood pressure
Patients with coagulation problem
Patients that suffer from malignancy
Patients who are under radiation
Immunosuppressive patients
Intervention groups
Interventions include applying licorice gel and placebo on the palatal wound
Main outcome variables
Evaluation the amount of pain and wound healing in the donor site in the hard palate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221126056617N1
Registration date:2022-12-31, 1401/10/10
Registration timing:registered_while_recruiting
Last update:2022-12-31, 1401/10/10
Update count:0
Registration date
2022-12-31, 1401/10/10
Registrant information
Name
Raziye Ghodsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4452 5041
Email address
rzghodsi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of licorice gel on pain and wound healing in donor site of free gingival graft in hard palate
Public title
Effect of licorice gel on wound healing in hard palate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in need of bilateral free gingival graft
Age between 18_60 years
Exclusion criteria:
Diabetic patients
Patients with uncontrolled blood pressure
Patients with coagulation problem
Patients that suffer from malignancy
Patients who are under radiation
Immunosuppressive patients
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
12 people are individually assigned to two treatments by means of two blocks of 6 using the sealed envelope site, and after passing the wash out period, they receive the opposite treatment of the first treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher dose not know whether the gel is a placebo or test, and the pharmacist gives the gel to the researcher in similar tubes to the researcher.
The patient is aware of the general nature of the study and knows that the licorice gel and placebo gel will be applied to him/her, but he/she did not know which side of licorice gel and which side of placebo gel will be applied.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Dental school, Ghasredasht Street, Shiraz Iran
City
Shiraz
Province
Fars
Postal code
71956-15878
Approval date
2022-11-14, 1401/08/23
Ethics committee reference number
IR.SUMS.DENTAL.REC.1401.084
Health conditions studied
1
Description of health condition studied
Evaluation healing of donor site
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The degree of wound healing
Timepoint
Evaluation the degree of healing on days 7,14,and 21 after surgery
Method of measurement
Photography and H2O2 test
2
Description
Degree of pain
Timepoint
Evaluation the amount of pain on days1,3,5,7, and14 after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Type of consumable:licoriece gel10%,1ml per use,use the gel twice a day for 7 days,using a sterile Q-Tip 1ml of gel is applied.The gels are prepared manually by the pharmacist.
Category
Treatment - Drugs
2
Description
Control group: Placebo gel,1ml twice a day for 7 days.The gels are prepared manually by the pharmacist
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Shiraz University of Medical Sciences
Full name of responsible person
Zahra Emami
Street address
Dental School, Ghasredasht Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3626 3193
Email
Zahra_emami63@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
7th floor ,Research and technology department,Shiraz University of Medical Sciences,Zand St.,Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Raziye Ghodsi
Position
Periodontics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental school,Ghasredasht Avn,Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 936 677 9660
Email
rzghodsi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Raziye GHodsi
Position
Periodontics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental school,Ghasredasht Ave,Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 936 677 9660
Email
rzghodsi1992@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Raziye Ghodsi
Position
Periodontics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental School,Ghasredasht Ave,Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 936 677 9660
Email
rzghodsi1992@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
No special conditions are required to access the data