Protocol summary

Study aim
Evaluating the effect of ethanol extract of propolis mucoadhesive on palatal epithelial wound healing and complications after free gingival graft surgery.
Design
Randomized clinical trial with a control group, with parallel groups, double-blind, randomized, phase 0 on 32 patients. For randomization, kitset.ir will be used.
Settings and conduct
This clinical trial was conducted in the periodontics department of Babol Dental School with 32 patients who were randomly divided into two groups and free gingival grafting surgery was done in the same way for both groups and 2 substances produced by the pharmacologist randomly are placed in the palate donor site in two groups, will be done. In this study, the patients, the researcher and the data analyst are not aware of the type of substance used between the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years old Patients who need free gingival graft Sufficient dimensions of the free gingival graft donor site in the palate (length:10-15 mm, width: 5-8 mm, thickness:1-1.5 mm) Exclusion criteria: Systemic diseases and conditions affecting wound healing (such as uncontrolled diabetes, autoimmune diseases, history of alcoholism) Clinical attachment loss (greater than 3 mm) in the palatal site of premolars and maxillary first molars. Use of corticosteroids ، antibiotics in the last month Pregnancy or breastfeeding smoking Allergy to amoxicillin-ibuprofen-chlorhexidine mouthwash ,bee products Asthma
Intervention groups
32 patients who referred to periodontics department of Babol Dental School are selected and divided into two groups of 16 member and the substances produced (A-B) will be randomly placed in the ulcerated palate donor site
Main outcome variables
The response to pain Response to thermal stimulus Epithelialization and degree of color adaptation, contour and distortion of the palate site

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240305061182N1
Registration date: 2024-07-19, 1403/04/29
Registration timing: prospective

Last update: 2024-07-19, 1403/04/29
Update count: 0
Registration date
2024-07-19, 1403/04/29
Registrant information
Name
Safa Raeisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3329 8130
Email address
raeisi.safa1996@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-21, 1403/04/31
Expected recruitment end date
2025-07-22, 1404/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of ethanolic extract of propolis mucoadhesives on palatal epithelial wound healing and post-operative complications after free gingival graft surgery
Public title
Evaluating the effect of ethanol extract of propolis on palatal wound healing and complications after gingival graft surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients over 18 years old patients who need free gingival graft The existence of sufficient dimensions of the free gingival graft donor site in the palate (length :10-15 mm, width :5-8 mm, thickness:1-1.5 mm)
Exclusion criteria:
Systemic diseases and conditions affecting wound healing (such as uncontrolled diabetes, autoimmune diseases, history of alcoholism) Clinical attachment loss(greater than 3 mm) in the palatal site of premolars and maxillary first molars. Use of corticosteroids Use of antibiotics in the last month Smoking Allergy to amoxicillin-ibuprofen-chlorhexidine mouthwash Allergy to bee products Asthma
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized clinical trial in order to randomize participants in different study groups, the kitset.ir will be used and the random number generation option will be done to determine case and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The studied groups are not informed in order to enter the case or control group in surgery. Patients do not know which type of mucoadhesive is placed in their palate wound area Researcher is not informed about the type of substance used between the case and control groups. The data analyst is not informed about the type of substance used between the case and control groups. The placebo in this study is the mucoadhesive group without propolis
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganj afrouz Ave., Babol Town
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2024-05-31, 1403/03/11
Ethics committee reference number
IR.MUBABOL.REC.1403.065

Health conditions studied

1

Description of health condition studied
The wound of palate in patients who need gingival graft
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Response to pain in patients after surgery
Timepoint
on days 3-7-14-21-42
Method of measurement
VAS (VISUAL ANALOGUE SCALE)

2

Description
Response of patients to thermal stimuli after surgery
Timepoint
On days 3-7-14-21
Method of measurement
VAS (VISUAL ANALOGUE SCALE)

3

Description
Complete epithelialization
Timepoint
on days 3-7-14-21-42
Method of measurement
Landry healing index

4

Description
Evaluating the degree of color matching, contour and distortion
Timepoint
on days 3-7-14-21-42
Method of measurement
Modified Manchester Scar Proforma index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Mucoadhesive containing 10% ethanol extract of propolis that produced in the Department of Pharmacology of Babol University of Medical Sciences, which will be placed once in the patient's palatal wound immediately after free gingival graft surgery.
Category
Treatment - Drugs

2

Description
Control group: Mucoadhesive (placebo) that produced in the Department of Pharmacology of Babol University of Medical Sciences, which will be placed once in the patient's palatal wound immediately after free gingival graft surgery
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dentistry Faculty of babol university of medical science
Full name of responsible person
Safa Raeisi
Street address
Ganj afrouz ave.; Babol town
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
Email
raeisi.safa1996@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Ganj afrouz ave.,Babol Town
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
raeisi.safa1996@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Niloufar Jenabian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
periodontist
Street address
Ganj afrouz ave.; Babol Town
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
njenabian@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Niloufar Jenabian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Periodontist
Street address
Ganj afrouz ave., Babol Town
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
njenabian@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Safa Raeisi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ganj afrouz ave.,Babol Town
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
raeisi.safa1996@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be 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
The data will be identified and stored by assigning a code
When the data will become available and for how long
The access period starts 12 months after the publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
According to the acquisition of the code of ethics of the researchers by the Vice-Chancellor of Research and Technology of Babol University of Medical Sciences, the documents will be usable
From where data/document is obtainable
Dr. Niloufar Jenabian - Babol University of Medical Sciences
What processes are involved for a request to access data/document
Checking the eligibility of the applicant and having a code of ethics will be done by an academic center.
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