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IRCT20210306050605N1 IRCT 2021-04-20 Tabriz University of Medical Sciences 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 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 2021-05-22 anticipated 15 Complete https://irct.ir/trial/54854 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece. N/A periodontitis. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: the third implant.No substance is used. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Fereydoon Parnia
Golgasht ST, Daneshgah Ave, Tabriz university of medical sciencesا
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3335 3161 fereydoon.parnia@gmail.com Tabriz University of Medical Sciences scientific Solmaz Maleki Dizaj
Golgasht ST, Daneshgah Ave, Tabriz university of medical sciences
Tabriz Iran (Islamic Republic of) 5166614766 009833353161 maleki.s.89@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Both 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 M27.62 Post-osseointegration biological failure of dental implant Treatment - Drugs Treatment - Drugs Treatment - Drugs 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. 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. Control group: the third implant.No substance is used. 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. Tabriz University of Medical Sciences Approved 2021-02-28 Ethics committee of Tabriz university of medical sciences Golgasht st, Daneshgah Ave, Tabriz university of medical sciences Tabriz East Azarbaijan Iran (Islamic Republic of)