Protocol summary

Study aim
To determine the effects of hyaluronic acid (HA) mucoadhesive films with two different concentrations on palatal epithelial wound healing and post-operative discomforts after free gingival graft (FGG) surgery
Design
Clinical trials with a control group, with parallel groups, double-blind, randomized. Patients will randomly divided into three groups using the option of generating random numbers in https://kitset.ir.
Settings and conduct
Patients selected from candidates for FGG surgery referred to the periodontology department of Babol University of Medical Sciences in 1401.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patients over the age of 18; 2. Patients who required free gingival graft; 3. Presence of sufficient donor tissue dimensions in the palate (length: 10-15mm, width: 5-8mm, thickness: 1-1.5mm); Exclusion criteria: 1. Systemic diseases and conditions affecting wound healing (such as uncontrolled diabetes, autoimmune diseases, history of alcoholism); 2. Presence of attachment loss (greater than 3mm) in the palatal area of premolars and first maxillary molars; 3. Use of corticosteroids; 4. Use of antibiotics in the past month; 5. Pregnancy or breastfeeding; 6. Smoking.
Intervention groups
Giving sufficient information, taking informed consent, Phase I periodontal therapy, Harvesting free gingival graft, Placing mucoadhesive films containing 0.8% HA (test group1), mucoadhesive films containing 0.2% HA (test group2) and HA free biofilms (control group) in the donor site, stabilizing it by sutures, Covering it with periodontal dressing, Regular evaluation on days 3, 7, 14, 21 and 42 after surgery.
Main outcome variables
If the results are statistically significant, using mucoadhesive biofilms containing HA could be considered as an adjunctive way for accelerating palatal epithelial wound healing and reducing post-operative discomforts of FGG surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100427003813N12
Registration date: 2022-04-14, 1401/01/25
Registration timing: registered_while_recruiting

Last update: 2022-04-14, 1401/01/25
Update count: 0
Registration date
2022-04-14, 1401/01/25
Registrant information
Name
Niloofar Jenabian
Name of organization / entity
Dental Faculty of University of Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 1408
Email address
n.jenabian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-08, 1401/01/19
Expected recruitment end date
2022-08-08, 1401/05/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of hyaluronic acid mucoadhesive films with two different concentrations on palatal epithelial wound healing and post-operative discomforts after free gingival graft surgery
Public title
Evaluating the effects of hyaluronic acid mucoadhesive films with two different concentrations on palatal epithelial wound healing and post-operative discomforts after free gingival graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who required free gingival graft; Presence of sufficient donor tissue dimensions 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); Presence of attachment loss (greater than 3 mm) in the palatal area of ​premolars and first maxillary molars; Use of corticosteroids; Use of antibiotics in the past month; Pregnancy or breastfeeding; Smoking.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 39
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly grouping the participants, we will use the option of generating random numbers in https://kitset.ir. Then, according to the random numbers, the first 13 numbers are in the first group, the next 13 numbers are in the second group, and the last 13 numbers are in the third group. Finally, the labeled biofilms (by the pharmacologist) are used in individuals of the all three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The biofilms containing hyaluronic acid with two different concentrations and the biofilms without hyaluronic acid are labeled with numbers by the pharmacologist and provided for the operator. The operator will be unaware of the type of biofilm used in the patient.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Babol University of Medical Sciences
Street address
Ganj Afrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717649811
Approval date
2022-02-02, 1400/11/13
Ethics committee reference number
IR.MUBABOL.REC.1400.262

Health conditions studied

1

Description of health condition studied
palatal epithelial wound healing and post-operative discomforts after free gingival graft surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Complete epithelialization of the donor site in palate
Timepoint
3, 7, 14, 21 and 42 days after surgery
Method of measurement
Landry 's healing index

2

Description
Color matching, contour and distortion of the donor site in palate
Timepoint
3, 7, 14, 21 and 42 days after surgery
Method of measurement
Modified Manchester Scar Proforma index

3

Description
Postoperative pain
Timepoint
3, 7, 14 and 21 days after surgery
Method of measurement
Visual analogue scale (VAS)

4

Description
Patient response to thermal stimulus after surgery
Timepoint
3, 7, 14 and 21 days after surgery
Method of measurement
Visual analogue scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: mucoadhesive films containing hyaluronic acid 0.8%
Category
Treatment - Other

2

Description
Intervention group 2 : mucoadhesive films containing hyaluronic acid 0.2%
Category
Treatment - Other

3

Description
Control group: mucoadhesive films without hyaluronic acid
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Periodontics department, School of Dentistry, Babol University of Medical Sciences
Full name of responsible person
Parisa Nabiyi
Street address
Ganj Afrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717649811
Phone
+98 919 347 3829
Email
prs.nby@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Ganjafroz Ave.
City
Babol
Province
Mazandaran
Postal code
4717649811
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.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
Niloofar Jenabian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717649811
Phone
+98 11 1229 1408
Fax
Email
n.jenabian@mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Niloofar Jenabian
Position
Prefessor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717649811
Phone
+98 11 1229 1408
Fax
+98 11 1229 1093
Email
n.jenabian@mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Parisa Nabiyi
Position
Postgraduate student of periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717649811
Phone
+98 11 3229 9721
Email
prs.nby@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
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
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