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Comparison of the effect of oral consumption of bromelain and curcumin on the healing process of the palatal wound, caused by free gingival graft removal; A randomized clinical trial

Protocol summary

Study aim
Comparison of the effect of oral curcumin and bromelain on the healing of palatal wound caused by free gingival graft removal
Design
Clinical trial with a control group, with parallel groups, three blinded, randomized, phase 1 on 57 patients. The rand function of Excel software was used for randomization.
Settings and conduct
The study was carried out in the Faculty of Dentistry of Medical Sciences in Tehran. At intervals of 7-14-21-28 days after surgery, patients are measured to evaluate the variables of epithelization level, pain and remaining wound area.
Participants/Inclusion and exclusion criteria
All patients over 18 years of age who need free gingival grafting treatment around teeth, must maintain proper oral hygiene (patient index less than 20%) Exclusion criteria: weak and mentally disabled patients, smoking, the presence of a pocket greater than 4 mm in the surgical area, systemic diseases that are contraindications to periodontal surgeries or interfere with tissue repair, such as uncontrolled diabetes, treatment with steroids, High dose radiotherapy or treatments that weaken immunity, pregnancy, breastfeeding, history of drug use that interferes with healing or causes an increase in the volume of gums, as well as patients suffering from various types of mucosal skin diseases or a history of recurrent plague.
Intervention groups
After free gum graft surgery (Atkins and Sullivan method), patients are randomly divided into 3 groups as follows: Control group: receive two placebo capsules daily for 7 days. The curcumin group received two 500 mg curcumin capsules daily for 7 days Bromelain group: they receive two 500 mg bromelain capsules daily for 7 days All patients use antibiotic amoxicillin 500 mg and chlorhexidine mouthwash 0.12% (twice a day) for a week (gelofen 400 mg every 6 hours).
Main outcome variables
Pain reduction, faster wound healing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231003059601N1
Registration date: 2024-05-09, 1403/02/20
Registration timing: registered_while_recruiting

Last update: 2024-05-09, 1403/02/20
Update count: 0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
Zahra Parnia Baran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5586 0867
Email address
zahraparniabaran14@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-04-06, 1403/01/18
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
2024-04-20, 1403/02/01
Actual recruitment end date
2025-06-05, 1404/03/15
Trial completion date
2025-07-06, 1404/04/15
Scientific title
Comparison of the effect of oral consumption of bromelain and curcumin on the healing process of the palatal wound, caused by free gingival graft removal; A randomized clinical trial
Public title
Comparison of the effect of oral consumption of pineapple and turmeric extract on the healing process of the palatal wound caused by free gingival graft removal; Randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old who need free gingival graft treatment around teeth good oral hygiene (patient index less than 20%)
Exclusion criteria:
mentally disabled patients smoking The presence of a pocket above 4 mm in the surgical area Systemic diseases that are contraindications to periodontal surgeries or interfere with tissue repair using high dose steroids Radiotherapy or immunosuppressive treatments pregnancy breastfeeding A history of taking medication that interferes with healing or causes an increase in gum volume. Patients who suffer from various mucocutaneous diseases or a history of recurrent aphtus
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 54
Actual sample size reached: 57
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced Blocked Randomization Randomization unit: individual How to randomize: using Excel software Randomization Tool: Codes are attached to files in invisible sealed envelopes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, both the doctor who performs the surgery and the patient are unaware of which group the patient belongs to. Similarly, the statistical analyst and the person who delivers the medicine to the patient and explains how to use it to the patient are not aware of which medicine the patient is receiving.
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
Tehran University of Medical Sciences, North Kargar Street, next to the Atomic Energy Organization, before the exit of Hakim Sharq Highway, Faculty of Dentistry,
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1402.115

Health conditions studied

1

Description of health condition studied
Wound healing, pain, free gum graft surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Remaining wound area in percent
Timepoint
7-14-21-28 days after free gum graft surgery
Method of measurement
Photographs will be taken from the area of the palatal wound caused by surgery on days 0, 7, 14, 21 and 28 using a CANNON 850D camera and then using Image J software (NIH, Bethesda, USA). The area of the wound will be measured in square millimeters and changes will be recorded

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Treatment - Drugs

2

Description
Intervention group:
Category
Treatment - Drugs

3

Description
Control group:
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Faculty of Dentistry, Medical Sciences
Full name of responsible person
Zahra Parnia Baran
Street address
Tehran University of Medical Sciences, North Kargar Street, next to the Atomic Energy Organization, before the exit of Hakim Sharq Highway, Faculty of Dentistry,
City
Tehran
Province
Tehran
Postal code
Phone
+98 938 227 7316
Email
zahraparniabaran14@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Siamak yaghobee
Street address
Faculty of Dentistry, Tehran University of Medical Sciences, North Kargar Street, next to the Atomic Energy Organization, before the exit of Hakim Sharq Highway
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8835 1170
Email
s_yaghobee@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Parnia Baran
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tehran University of Medical Sciences, North Kargar Street, next to the Atomic Energy Organization, before the exit of Hakim Sharq Highway
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8835 1170
Email
zahraparniabaran14@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Parnia Baran
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tehran University of Medical Sciences , North Kargar Street, next to the Atomic Energy Organization, before the exit of Hakim Sharq Highway
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8835 1170
Email
zahraparniabaran14@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Parnia Baran
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tehran University of Medical Sciences, North Kargar Street, next to the Atomic Energy Organization, before the exit of Hakim Sharq Highway
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8835 1170
Email
zahraparniabaran14@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
No - There is not 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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