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Investigating the effectiveness of the topical use of curcumin on the wound healing process after molar teeth extraction

Protocol summary

Study aim
Determining the effect of topical application of curcumin on the process of socket healing and reduction of pain in extraction of molar teeth
Design
A simple randomization method (coin flip) is used to assign patients to two groups.
Settings and conduct
In the intervention group, 500 mg of curcumin capsule mixed with 2 ml of normal saline is placed on a gel tampon and then placed in the wound. In the control group, only 2 ml of normal saline is placed on the tampon gel and then placed in the wound. The patient does not know the type of intervention.
Participants/Inclusion and exclusion criteria
Patients who are candidates for extraction of non-preservable molar teeth are included in the study if they wish. Also, patients with vascular or blood disorders, users of exogenous corticosteroids and anticoagulants such as aspirin, patients with a history of asthma and allergies, patients with uncontrolled systemic disorders, patients with uncontrolled respiratory, digestive, kidney and lung cardiovascular diseases, Patients with a history of head and neck radiotherapy or chemotherapy, with dry mouth, with a history of creating a dry socket after tooth extraction, users of removable prostheses, pregnant women and nursing mothers, patients with systemic fungal infections, acute infections and tuberculosis (active or off) are excluded from the study. Also, the exclusion criteria include patients who have used painkillers or anti-inflammatories in the week leading up to the surgery. Patients who consume any amount of cigarettes, alcohol, drugs, or stimulants, or the target tooth has been symptomatic in the week leading up to the surgery, will also be excluded from the study.
Intervention groups
The first group (control group) will be treated with placebo and the second group (intervention group) will be treated with curcumin.
Main outcome variables
Wound healing status; The amount of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231205060267N1
Registration date: 2023-12-06, 1402/09/15
Registration timing: prospective

Last update: 2023-12-06, 1402/09/15
Update count: 0
Registration date
2023-12-06, 1402/09/15
Registrant information
Name
Mostafa Sharifzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7795 3395
Email address
mostafa.a.sharifzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of the topical use of curcumin on the wound healing process after molar teeth extraction
Public title
curcumin effect in tooth extraction healing
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for extraction of unmaintainable molar teeth
Exclusion criteria:
Patients with vascular or blood disorders Users of exogenous corticosteroids and anticoagulants such as aspirin Patients with a history of asthma and allergies Patients with uncontrolled systemic disorders, patients with uncontrolled respiratory, digestive, renal and pulmonary cardiovascular diseases Patients with a history of head and neck radiotherapy or chemotherapy Patients with dry mouth Patients with a history of developing a dry socket after tooth extraction Consumers of removable prostheses pregnant women and nursing mothers Patients with systemic fungal infections, acute infections and tuberculosis (active or silent) Patients who have used painkillers or anti-inflammatories in the week leading up to tooth extraction Patients who consume any amount of cigarettes, alcohol, drugs or stimulants The tooth in question has been symptomatic in the week leading up to the extraction
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method (coin flip) is used to assign patients to two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
A gel tampon will be applied to all patients participating in this clinical trial. In the intervention group, the tampon gel is impregnated with curcumin as the drug, and in the control group, it is impregnated with normal saline as a placebo. Therefore, the participants and their companions, who are responsible for taking care of them, are aware that they are participating in this clinical trial, but they are not aware of which of the two intervention or control groups they belong to. From their point of view, intervention has been carried out for them.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of dental school of Tehran medical science Islamic Azad university
Street address
No. 9, 9th Neyestan St., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2023-11-27, 1402/09/06
Ethics committee reference number
IR.IAU.DENTAL.REC.1402.111

Health conditions studied

1

Description of health condition studied
Wound healing status after molar tooth extraction
ICD-10 code
S01.5
ICD-10 code description
Open wound of lip and oral cavity

Primary outcomes

1

Description
Wound healing score in clinical examination
Timepoint
Wound healing scoring on day 7 and 14 after tooth extraction
Method of measurement
Scoring of wound healing is based on four criteria: tissue color, response to palpation, the presence of granulation tissue, and the state of the wound margin during clinical examination.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 500 mg of curcumin capsule mixed with 2 ml of normal saline is placed on a gel tampon and then placed on the wound.
Category
Rehabilitation

2

Description
Control group: Only 2 ml of normal saline is placed on the tampon gel and then placed on the wound.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental school clinic of Tehran medical science Islamic Azad university
Full name of responsible person
Morteza Neshandar
Street address
No. 9, 9th Neyestan, Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
info@tmsiau.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi - Research Deputy of Dental school of Tehran Islamic Azad university of medical sciences
Street address
No. 9, 9th Neyestan, Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
info@tmsiau.ir
Web page address
https://tms.iau.ir/dental/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mostafa Sharifzadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
3rd floor, No. 22, Dardasht St., Narmak
City
Tehran
Province
Tehran
Postal code
1651917443
Phone
+98 21 7795 3395
Fax
Email
mostafa.a.sharifzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mostafa Sharifzadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
3rd floor, No. 22, Dardasht St., Narmak
City
Tehran
Province
Tehran
Postal code
1651917443
Phone
+98 21 7795 3395
Fax
Email
mostafa.a.sharifzadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mostafa Sharifzadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
3rd floor, No. 22, Dardasht St., Narmak
City
Tehran
Province
Tehran
Postal code
1651917443
Phone
+98 21 7795 3395
Fax
Email
mostafa.a.sharifzadeh@gmail.com

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data potentially shareable after de-identifying individuals (in thesis form)
When the data will become available and for how long
The access period starts after the results are printed
To whom data/document is available
All those who have permission to access the theses archive of the Faculty of Dentistry library of Tehran Azad University of Medical Sciences.
Under which criteria data/document could be used
for research
From where data/document is obtainable
Faculty of Dentistry library of Tehran Azad University of Medical Sciences
What processes are involved for a request to access data/document
Go to the library of the Faculty of Dentistry of Tehran Azad University of Medical Sciences, present your ID card and receive the thesis
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