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The effect of the photodynamic therapy with Nano-emodin on palatal wound healing after free gingival graft; a parallel clinical trial

Protocol summary

Study aim
Determining the clinical effect of photodynamic therapy with nano-emodin on palatal wound healing after free gum graft surgery.
Design
This study will be conducted as a controlled, triple double and parallel clinical trial on 51 patients. after graft harvesting, The patients will be randomly using a computerized block randomization process divided into three groups.
Settings and conduct
The study will be conducted in the Department of Periodontology, Faculty of Dentistry, Tehran University of Medical Sciences. Patients will be randomly divided into three groups receiving gel containing nano-emodin alone, group receiving gel containing nano-emodin and photodynamic therapy and control (receive placebo without radiation). Patients, clinical examiners and epidemiologists were blind to the study.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age and systemically healthy that they need free gingival graft with a maximum width of 10 mm and a length of 15 to 25 mm were included in the study. smokers, take medications, or have conditions that interfere with wound healing were excluded from the study.
Intervention groups
After harvesting the graft from the palatal, the patients were divided into three groups, in the two test groups, nano-emodin gel was applied for 5 minutes with and without LED laser radiation to the effect of photodynamic therapy, on the palate wound. In the control group, only placebo gel is used, and in all groups, a surgical dressing is placed on the wound.
Main outcome variables
Investigate the amount of epithelialization by 3% hydrogen peroxide Measurement of the remaining wound area using ImageJ software Measurement color matching with Photoshop using standard photographs The amount of pain based on the VAS scale and the presence or absence of bleeding in the first 11 days after surgery through a questionnaire by the patient

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221212056791N1
Registration date: 2023-01-08, 1401/10/18
Registration timing: prospective

Last update: 2023-01-08, 1401/10/18
Update count: 0
Registration date
2023-01-08, 1401/10/18
Registrant information
Name
Mahdi Isa Abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3891 0857
Email address
mahdi.isa2758@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the photodynamic therapy with Nano-emodin on palatal wound healing after free gingival graft; a parallel clinical trial
Public title
Effect of Nano-emodin on palatal wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients age ≥ 18 years. systemically healthy. The graft dimensions were taken with a maximum width of ten millimeters and a length of fifteen to twenty-five millimeters. Patients should sign the informed consent form to participate in the study after receiving sufficient information about the risks, advantages and disadvantages.
Exclusion criteria:
Active gag reflux. Smoking and alcohol consumption, periodontal diseases, traumatic occlusion systemic diseases considered either as the contra-indications of periodontal surgeries or in contradiction with wound healing process such as diabetes and history of treatment with high dose steroids taking anti-coagulation medications, radiotherapy or other types of therapies suppressing the immunity system, pregnancy, breast-feeding, digestive disorders. a history of taking medications distorting the wound healing process or inducing gingival enlargement. the patients missing the follow-up sessions after the surgery.
Age
From 18 years old to 70 years old
Gender
Both
Phase
0
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 51
Randomization (investigator's opinion)
Randomized
Randomization description
After graft harvesting, the patient was randomly assigned into one of the three groups of treatment using a randomization software. Random allocation, patient enrolment, and assignment was done by different clinicians. An epidemiologist who was not aware of the treatment modalities generated the random allocation sequence using a computerized block randomization process.
Blinding (investigator's opinion)
Triple blinded
Blinding description
To be blind, the examiners were asked to comment only on the final outcome and then their comments were recorded. Statistical analysis was done in three groups A, B and C so that the analyzer is blind to the results. A placebo gel was used in the control group to make the patient blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
At the end of North Kargar Street, before Hakim Highway, Faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2022-09-05, 1401/06/14
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1401.086

Health conditions studied

1

Description of health condition studied
Evaluation of palatal wound healing after free gingival graft surgery due to lack of attached gingiva
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The clinical effect of photodynamic therapy using Nano-Emodin on the palatal wound healing after free gingival graft surgery.
Timepoint
Comparison of the average area of the remaining wound in the palate at intervals of 7, 14, 21 and 28 days after surgery. Comparison of the amount of bleeding after surgery in the first 7 days. Comparison of the degree of color matching and epithelialization in the time interval 7, 14, 21, 28. Comparison of the average index of pain and discomfort in the first 10 days after surgery
Method of measurement
The average area of the remaining wound in the area by image j program. Comparison of the amount of bleeding through a questionnaire. Comparison of color matching with Adobe Photoshop software. Examining the amount of epithelialization through 3% hydrogen peroxide. Index of pain and discomfort using Visual Analogue Scale.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Placing a gel containing 10% Nano-Emodin for 5 minutes on the wound surface
Category
Treatment - Drugs

2

Description
Intervention group: Placing a gel containing 10% Nano-Emodin for 5 minutes on the wound surface along with LED radiation for 1 minute
Category
Treatment - Drugs

3

Description
Control group: Placing placebo gel without LED radiation
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Periodontics, Faculty of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Siamak yaghobee
Street address
At the end of North Kargar Stree, before Hakim Highway, Tehran Faculty of Dentistry and Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Fax
Email
dentistry@tums.ac.ir
Web page address
https://dentistry.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Siamak Yaghobee
Street address
At the end of North Kargar Street, before Hakim Highway, Tehran Faculty of Dentistry and Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Email
s_yaghobee@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
medical University Tehran
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
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Isaabadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Nirogah, Tawheed Square, Javadalameh St., No. 161, 5th Alley
City
Qom
Province
Ghoum
Postal code
3717896519
Phone
+98 25 3891 0857
Email
mahdi.isa2758@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Siamak yaghobee
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
At the end of North Kargar Street, befor Hakim Highway, Tehran Faculty of Dentistry and Medical Sciences, Periodontics Department
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
009842794000
Email
s_yaghobee@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Houry Asl Rousta
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
At the end of North Kargar Street, before Hakim Highway, Tehran Faculty of Dentistry and Medical Sciences, Periodontics Department
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
009842794000
Email
h_aslroosta@sina.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Gathered data will be analyzed and then published.
When the data will become available and for how long
It will be determined after the article is published.
To whom data/document is available
Everyone (depending on the journal policies)
Under which criteria data/document could be used
Published article will be public.
From where data/document is obtainable
The journal that the paper is published in.
What processes are involved for a request to access data/document
Just sending Email to corresponding author.
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