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IRCT20211212053373N1 IRCT 2022-01-23 Tabriz University of Medical Sciences The effect of the herring gum on the salivary bacteria, the salivary acidity, gingival plaque and bleeding Clinical evaluation of the effect of Hypericum perforatum gum on salivary streptococcus mutans count, salivary pH, plaque index and gingival bleeding 2022-01-19 anticipated 54 Complete https://irct.ir/trial/60614 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization will be done by using a random number table. Random number tables are generated by computers that randomly adjust numbers. These tables are many and have different names; these tables have random numbers in both rows and columns and usually have more than 99 rows and columns. The rows and the columns are arranged in five-digit blocks next to each other and separately to use. Facilitate it. Due to the fact that the study is two-sided, except for the supervisor as the third person in the study, none of the volunteers or students doing the project will be aware of the study person in the control or intervention group and to define information for individuals will be , Blinding description: In this study, the participants will be provided with the necessary explanations and description of random selection of their presence in the control and intervention group and then they will sign the consent. The participants, the student with the project as a researcher, the clinical supervisor, the initial draft author of the article and the statistical consultant responsible for data analysis are blind and only the supervisor as an outcome assessor knows how to assign individuals to the control and intervention group. To ensure non-disclosure, each candidate will be assigned a code (due to the fact that the study is at the university level there is no safety monitoring committee) . N/A Periodontal diseases. Intervention 1: Intervention group: The plant will be collected from the botanical garden of Tabriz University. After getting the approval of the herbarium of the University of Medical Sciences and obtaining its code, 300 grams of dried flowering branches will be pulverized. Plant extraction will be done by percolation method using 70% ethanol. The phenol and flavonoid levels of the extract will be determined. In the next step, the raw materials for making chewing gum will be prepared as follows. Chewing gum base is an insoluble and ineffective non-nutritious product that is used as an oral support and chewing gum solution (sugar, glucose, poly oils and flavorings). The gum base composition may contain ordinary elastomer solvents to help soften the elastomer base component. The melting process was performed in the containers at about 50-60 ° C on a steam bath and allowed to cool to 15-20 ° C. Liquid glucose of aspartame glycerin and other non-sucrose sweeteners will be added to the required amount after mixing and extracting, and the mass of each piece of gum will be determined. The remaining amount of solid used will be up to 50-20 mg inside the formulation. The gums will be prepared together and the uniformity test and the release rate of the drug or active substance will be measured according to the standard method. The dimensions of the products in the clean glass molds will be set. The next step in the weight uniformity test is to evaluate the mechanical properties of the gum, such as the amount of traction, which is performed using a traction tester in which a piece of gum is fixed between two clamps. In this test, the gum is pulled by a clamp and pulled until it fails or loses its elasticity. Using this process, quantitative measurements of mechanical properties such as performance strength, ultimate tensile strength, and modulus or Young modulus flexibility can be obtained from segmented stress-strain curves. Evaluation of organoleptic properties and release rate of active ingredients will be done in the laboratory. Lemon powder will be added at the end of the formulation to make all participants feel the same taste. The amount of chewing gum used daily by each person will be six pieces of chewing gum, one after each meal and three pieces during the day for at least 15 minutes for 14 consecutive days. Intervention 2: Control group: Chewing gum is an extract of the hypericum plant. Chewing gum base is an insoluble and ineffective non-nutritious product that is used as an oral support and chewing gum solution (sugar, glucose, poly oils and flavorings). The gum base composition may contain ordinary elastomer solvents to help soften the elastomer base component. The melting process was performed in containers at about 50-60 ° C on a steam bath and allowed to cool to 15-20 ° C. Liquid glucose of aspartame glycerin and other non-sucrose sweeteners will be added to the required amount after mixing and extracting and the mass of each piece of gum will be determined. The dimensions of the products will be adjusted in clean glass molds. The next step in the weight uniformity test is to evaluate the mechanical properties of the gum, such as the amount of traction, which is performed using a traction tester in which a piece of gum is fixed between two clamps. In this test, the gum is pulled by a clamp and pulled until it fails or loses its elasticity. Using this process, quantitative measurements of mechanical properties such as performance strength, ultimate tensile strength, and modulus or Young modulus flexibility can be obtained from segmented stress-strain curves. Evaluation of organoleptic properties and release rate of active ingredients will be done in the laboratory. In order for all participants to feel the same taste, lemon powder will be added at the end of the formulation. The amount of chewing gum used by each person is six pieces of chewing gum daily, one after each meal and three pieces during the day for at least 15 minutes for 14 It will be a consecutive day. Yes - There is a plan to make this available What will be shared: Total potential data after non-identification of individuals When: Access period starts 3 months after the results are published To whom: Includes all people in the academia and the industry Conditions: For the clinical studies and completion and promotion Where to obtain: Dr. Maryam Kooh Soltani,mkoohsoltani@yahoo.com How to obtain: Getting the approval of the Research Committee of the University of Medical Sciences and the consent of the project owners Comments:
public Dr. Maryam Kooh Soltani
Azadi St., Golgasht St.
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 5965 mkoohsoltani@yahoo.com Tabriz University of Medical Sciences scientific Dr. Maryam Kooh Soltani
Azadi St., Golgasht St.
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 5965 mkoohsoltani@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Participants should not have systemic disease Participants should have acceptable oral hygiene (they should not have obvious dental plaque) Age range: 18 to 65 years 18 years 65 years Both Taking antibiotics or drugs that affect saliva Use of oral appliance Lack of proper cooperation People who breastfeed or are pregnant. K05.6 Periodontal disease, unspecified Prevention Placebo Intervention group: The plant will be collected from the botanical garden of Tabriz University. After getting the approval of the herbarium of the University of Medical Sciences and obtaining its code, 300 grams of dried flowering branches will be pulverized. Plant extraction will be done by percolation method using 70% ethanol. The phenol and flavonoid levels of the extract will be determined. In the next step, the raw materials for making chewing gum will be prepared as follows. Chewing gum base is an insoluble and ineffective non-nutritious product that is used as an oral support and chewing gum solution (sugar, glucose, poly oils and flavorings). The gum base composition may contain ordinary elastomer solvents to help soften the elastomer base component. The melting process was performed in the containers at about 50-60 ° C on a steam bath and allowed to cool to 15-20 ° C. Liquid glucose of aspartame glycerin and other non-sucrose sweeteners will be added to the required amount after mixing and extracting, and the mass of each piece of gum will be determined. The remaining amount of solid used will be up to 50-20 mg inside the formulation. The gums will be prepared together and the uniformity test and the release rate of the drug or active substance will be measured according to the standard method. The dimensions of the products in the clean glass molds will be set. The next step in the weight uniformity test is to evaluate the mechanical properties of the gum, such as the amount of traction, which is performed using a traction tester in which a piece of gum is fixed between two clamps. In this test, the gum is pulled by a clamp and pulled until it fails or loses its elasticity. Using this process, quantitative measurements of mechanical properties such as performance strength, ultimate tensile strength, and modulus or Young modulus flexibility can be obtained from segmented stress-strain curves. Evaluation of organoleptic properties and release rate of active ingredients will be done in the laboratory. Lemon powder will be added at the end of the formulation to make all participants feel the same taste. The amount of chewing gum used daily by each person will be six pieces of chewing gum, one after each meal and three pieces during the day for at least 15 minutes for 14 consecutive days. Control group: Chewing gum is an extract of the hypericum plant. Chewing gum base is an insoluble and ineffective non-nutritious product that is used as an oral support and chewing gum solution (sugar, glucose, poly oils and flavorings). The gum base composition may contain ordinary elastomer solvents to help soften the elastomer base component. The melting process was performed in containers at about 50-60 ° C on a steam bath and allowed to cool to 15-20 ° C. Liquid glucose of aspartame glycerin and other non-sucrose sweeteners will be added to the required amount after mixing and extracting and the mass of each piece of gum will be determined. The dimensions of the products will be adjusted in clean glass molds. The next step in the weight uniformity test is to evaluate the mechanical properties of the gum, such as the amount of traction, which is performed using a traction tester in which a piece of gum is fixed between two clamps. In this test, the gum is pulled by a clamp and pulled until it fails or loses its elasticity. Using this process, quantitative measurements of mechanical properties such as performance strength, ultimate tensile strength, and modulus or Young modulus flexibility can be obtained from segmented stress-strain curves. Evaluation of organoleptic properties and release rate of active ingredients will be done in the laboratory. In order for all participants to feel the same taste, lemon powder will be added at the end of the formulation. The amount of chewing gum used by each person is six pieces of chewing gum daily, one after each meal and three pieces during the day for at least 15 minutes for 14 It will be a consecutive day. Percentage change in plaque index and gingival bleeding before and after chewing gum. Timepoint: Measurements at the beginning of the study and after 14 days of chewing gums. Method of measurement: Bleeding index, using periodontal prop in four levels of the sulcus, will be measured slowly for 30 seconds before and after using the chewing gum in each intervention and control group. Dental Plaque Index (DPI) will be calculated using the O’Leary index. Measurement of streptococcus mutans in saliva. Timepoint: Measurements at the beginning of the study and after 14 days of using chewing gum. Method of measurement: Samples will be sent to the microbiology laboratory to determine the number of Streptococcus mutans colonies, the data of the control group and the intervention group will be analyzed using the Analysis of Covariance (ANCOVA), first in each group separately and then jointly. Saliva collection of these individuals will be done by the unstimulated method and will be cultured in order to count the number of Streptococcus mutans in a specific medium of Mitis salivarius agar at 37 ° C. Saliva pH difference before and after using the vegetable gum. Timepoint: On the day 15 of the experiment. Method of measurement: 1 ml of saliva will be applied to the pH meter electrode for four consecutive measurements after 0, 5, 10, 15, 20 minutes of using the chewing gum. The final salivary pH will be recorded as the average of the three measurements. Independent t-test and covariance test will be used after measuring the pH of saliva in the two groups of control and intervention, before and after using chewing gum, with an average of three times. Tabriz University of Medical Sciences Approved 2021-12-06 Ethics Committee of Tabriz University of Medical Sciences Azadi St., Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)