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The antimicrobial effects of curcumin essential oil gel on reducing the microbial infection at the gingival fluid of the implant-abutment interface

Protocol summary

Study aim
The antimicrobial effects of curcumin essential oil gel on reducing the microbial infection at the gingival fluid of the implant-abutment interface
Design
A clinical assessment including a single group with two samples per patient. One implant will be as a test implant and the other as a control implant (without medication).
Settings and conduct
According to the defined including and excluding criteria, 15 patients who need at least 2 implants in one jaw will be selected for the study. In the first session, curcumin essential oil gel will be inserted into the test implant fixture and no substance will be used in the control implant. The restorative abutment will be closed. Then, in the three molding sessions (10, 15, and 30 days after the restorative abutment closure session), the patients will be sampled. Then, the prepared samples will be sent to the microbiology laboratory to measure the number of bacteria (as CFU).
Participants/Inclusion and exclusion criteria
Inclusion; Patients with high levels of oral health, patients with at least 2 implants in one jaw, patients of at least 18 years of age Exclusion Patients with low levels of oral health, pregnant and lactating women, patients have received antibiotics in the last 6 months, patients with any systemic disease such as diabetes that affects oral health, patients with cigarette or alcohol addiction, patients with a history of tetracycline allergy, patients with COVID19
Intervention groups
A test implant (curcumin gel) and a control implant (without any drug)
Main outcome variables
-Independent variable: Material type (curcumin-containing gel, curcumin-free gel) Dependent variable: the amounts of Colonies Forming Units

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200919048756N1
Registration date: 2020-09-25, 1399/07/04
Registration timing: prospective

Last update: 2020-09-25, 1399/07/04
Update count: 0
Registration date
2020-09-25, 1399/07/04
Registrant information
Name
Solmaz Maleki Dizaj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 3161
Email address
maleki.s.89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-18, 1399/11/30
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The antimicrobial effects of curcumin essential oil gel on reducing the microbial infection at the gingival fluid of the implant-abutment interface
Public title
The effects of curcumin gel on reducing the microbial infection at the implant-abutment interface
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with at least 2 implants in one jaw The depth of 1-3 mm for the implant's probe
Exclusion criteria:
Pregnant and lactating women Patients have received antibiotics in the last 6 months Patients with any systemic disease such as diabetes that affects oral health Patients with addiction to drugs, cigarettes or alcohol Patients with a history of tetracycline allergy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
More than 1 sample in each individual
Number of samples in each individual: 2
People with two implants in one jaw. One of them will be as a test implant and the other as a control implant (without medication).
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-09-07, 1399/06/17
Ethics committee reference number
IR.TBZMED.REC.1399.605

Health conditions studied

1

Description of health condition studied
Periodontitis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The measurement of the number of bacteria after placing curcumin gel in the implant for three times
Timepoint
Ten days, 15 days and 30 days after sample placement
Method of measurement
Bacterial colony counting method

Secondary outcomes

empty

Intervention groups

1

Description
Test group: one of the two implants of the patient, control group: other patient's implant, the substance used in the test group: curcumin gel with a concentration of 60 mg/ml, the substance used in the control implant: no substance, number and the duration of use: once for a month, how to use: inside the implant fixture
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Private office of Dr. Fereydoon Parnia
Full name of responsible person
Dr. Fereydoon Parnia
Street address
Fourth floor, Jahansar building, Saadi corner, Valiasr Avenue, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3332 0905
Email
fereydoon.parnia@gmail.com
Web page address
https://scholar.google.com/citations?user=R9VUDkYAAAAJ&hl=en

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3161
Email
maleki.s.89@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fereydoon parnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
0098041303353161
Email
fereydoon.parnia@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3161
Fax
Email
maleki.s.89@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3161
Email
maleki.s.89@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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Not applicable.
When the data will become available and for how long
From 2021 onwards.
To whom data/document is available
There is no limitation.
Under which criteria data/document could be used
Academic members of Iranian universities
From where data/document is obtainable
Dr. Solmaz Maleki Dizaj maleki.s.89@gmail.com
What processes are involved for a request to access data/document
Sending documents by email
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