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Comparison of the antibacterial effect of tetracycline gel and gel containing mesoporous silica nanoparticles loaded with tetracycline in the gingival sulcus fluid at the site of junction between the implant and the abutment

Protocol summary

Study aim
Comparison of the antibacterial effect of tetracycline gel and gel containing mesoporous silica nanoparticles loaded with tetracycline in the gingival groove fluid at the junction of implant and abutment
Design
A trial will include a group with three samples per person, two test implants, and one control implant (without medication).
Settings and conduct
According to the defined entry and exit criteria, 18 patients who need at least 3 mandibular implants are included in the study. In the uncovering session, tetracycline gel and gel containing mesoporous silica nanoparticles loaded with tetracycline are placed in two fixtures and no other substance is applied in the another fixture. Then, in three sessions of prosthesis impression, prosthesis delivery and one month after delivery, a sample of gingival groove fluid is prepared using a paper point and sent to the microbiology laboratory to measure the amount of bacteria present.
Participants/Inclusion and exclusion criteria
1.At least 3 implants in one jaw,minimum age of 18 years,pocket depth of implant 1-3,supra gingival margin,At least 4 months have passed since the extraction of the replacement teeth 2.Breastfeeding,Pregnancy,Patients receiving antibiotics in the last 6 months,systemic disease that affects oral health,Addiction,allergy to tetracycline,People with coronavirus and suspected of it,patients need graft and bone reconstruction,9- Presence of periodontal disease in other
Intervention groups
There will be two test implants (tetracycline gel and nanoparticle gel containing tetracycline) and one control implant (without any medication)
Main outcome variables
Ability to reduce microbial load and prevent pre-implantitis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210306050605N1
Registration date: 2021-04-20, 1400/01/31
Registration timing: prospective

Last update: 2021-04-20, 1400/01/31
Update count: 0
Registration date
2021-04-20, 1400/01/31
Registrant information
Name
fahimeh mirzaali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5921
Email address
negarmirzaali1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the antibacterial effect of tetracycline gel and gel containing mesoporous silica nanoparticles loaded with tetracycline in the gingival sulcus fluid at the site of junction between the implant and the abutment
Public title
Comparison of the effect of tetracycline gel and gel containing mesoporous silica nanoparticles loaded with tetracycline on reducing microbial infection at the junction of implant and abutment
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
1- Having at least 3 implants in one jaw 2- Having a minimum age of 18 years 3- The depth of the probe around the implant is between 1-3 mm (height of the abutment heel inside the gingiva is maximum 3 mm) 4- Possibility of placing zirconia crown with upper gingival margin 5- At least 4 months have passed since the extraction of the replacement teeth.
Exclusion criteria:
1- Pregnant and lactating women 2- Patients receiving antibiotics in the last 6 months 3- Having any systemic disease such as diabetes that affects oral health 4- Addiction to drugs, cigarettes or alcohol 5-History of allergy to tetracycline 6- Based on the flowchart of diagnosis of covid 19 in the levels of outpatient services for definite people with coronary heart disease and suspected of it (1. History of dry cough or chills or sore throat with shortness of breath with or without fever, which can be justified by another etiological factor 2. A patient with fever or respiratory symptoms (whatever the severity): A. Have a history of close contact with a probable / definite case of covid 19 within 14 days prior to the onset of symptoms. Health personnel) 7- Patients with bone thickness less than 5 mm in cbct and patients need graft and bone reconstruction 8- Presence of periodontal disease in other
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: 3
People who have 3 implants in the mandible, two of them will be as test implants and one of them will be as control implant (without medication).
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-02-28, 1399/12/10
Ethics committee reference number
IR.TBZMED.REC.1399.1096

Health conditions studied

1

Description of health condition studied
periodontitis
ICD-10 code
M27.62
ICD-10 code description
Post-osseointegration biological failure of dental implant

Primary outcomes

1

Description
The Measurement of the amount of bacteria after placing tetracycline gel and gel containing tetracycline-loaded nanoparticles in the implant for three times
Timepoint
10 days 15 days 30 days after placing the sample
Method of measurement
Bacterial colony counting method

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: first implant. Material used in the first intervention group:Tetracycline gel (with a water base containing one percent tetracycline and two percent gel) Frequency, method and duration of use: In the uncovering session, the gel is placed inside the implant with a syringe and the healing abutment is closed. Then, in three sessions: implantation, impression (10 days after the healing abutment closure session), prosthesis delivery (15 days after the impression session) and one month after prosthesis delivery, patients are sampled. Sampling intervals will be the same for all patients. To prepare the gel, carbomer 940 gel (drug grade, product of Bismuth Company) is used.
Category
Treatment - Drugs

2

Description
Intervention group: the second implant.Gel containing tetracycline-loaded mesoporous silica nanoparticles (with a mean particle size of 100 nm and needle morphology) containing tetracycline gel). Frequency, method and duration of use: In the uncovering session, the gel is placed inside the implant with a syringe and the healing abutment is closed. Then, in three sessions: implantation, impression (10 days after the healing abutment closure session), prosthesis delivery (15 days after the impression session) and one month after prosthesis delivery, patients are sampled. Sampling intervals will be the same for all patients. A summary of how mesoporous silica nanoparticles are prepared and how tetracycline is loaded into them is that the mixture of surfactant (CTAB), distilled water and sodium hydroxide (NaOH) is stirred on the stirrer for up to 80 ° C for 30 minutes. The pH of the solution is then adjusted to 12.2. In the next step, tetraethyl orthosilica (Sigma Aldrich brand) is added to the solution immediately under a 550 RPM stirrer. A white precipitate is deposited. The ambient temperature of the solution is maintained at 80 ° for two hours. Tetracycline (a product of Sigma) is dissolved in ethanol. The prepared nanoparticle powder is added to the drug solution. The resulting mixture is gently stirred at room temperature on the stirrer for 48 hours in the dark. The product is mesoporous silica nanoparticles contains tetracycline.
Category
Treatment - Drugs

3

Description
Control group: the third implant.No substance is used.
Category
Treatment - Drugs

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 Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3329 5132
Email
fereydoonparnia@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samie
Street address
Golgasht ST, Daneshgah Ave, Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3161
Email
negarmirzaali1@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 sciencesا
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3161
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
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
009833353161
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
Fahimeh Mirzaali
Position
Resident of prosthodontic dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golgasht ST, Daneshgah Ave, Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3161
Email
negarmirzaali1@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 limit
Under which criteria data/document could be used
Academic member of Iranian universities
From where data/document is obtainable
Dr. Fahimeh Mirzaali- negarmirzaali1@gmail.com
What processes are involved for a request to access data/document
Send documents by email
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