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IRCT20211221053478N1 IRCT 2022-07-27 Mashhad University of Medical Sciences The effect of oral irrigator on patients with gingival inflammation The effect of oral irrigator on periodontal indices in patients with generalized gingivitis 2022-08-12 anticipated 40 Complete https://irct.ir/trial/61450 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were randomly assigned to the intervention and control groups by block randomization using a table of random numbers. Sealed envelop were used for allocation of random numbers to the patients, Blinding description: The patients could not be blinded to the allocated procedure. However, the examiner who examine the plaque index, gingival index and bleeding on probing after the intervention was blinded to the group allocation of patients. Thus, the study had a single-blinded design. The statistician who analyzed the data was also blinded to the group allocation of patients. 2-3 Gingivitis. Intervention 1: Control group: After scaling patients' teeth, flossing (Mina brand) will be done twice a day for 4 weeks after brushing by people in the control group. Brushing will be done by Modified bass method and twice a day by Hi Dent brand manual toothbrush. The correct method of brushing and using dental floss will be taught by a trained evaluator. Intervention 2: Intervention group: Oral irrigator will be used after brushing in the intervention group. The duration of using the device is twice a day for 4 weeks. Brushing will be done by Modified bass method and twice a day by Hi Dent brand manual toothbrush. The correct method of brushing and using oral irrigator will be taught by a trained dental student. Oral irrigator under the registered name (Waterjet mouth washer with the ability to monitor and control the user's hygienic behavior) has been designed and patented by a private Iranian company (registration number: 72641) ( patent number: 103383). Unlike other existing devices based on mechanical mechanisms and piston performance, this device has been designed and manufactured based on electromechanical system and on centrifuge performance. The power of spraying system is between 10 to 70 psi and beats from 100 to 1000 times per minute according to microcontroller programming. The liquid used in the oral irrigator is distilled water. The method of using oral irrigator in the intervention group is taught that the person places the tip of the device at an angle almost perpendicular to the surface of the teeth and supra gingival on the teeth after brushing by trained evaluator. Yes - There is a plan to make this available What will be shared: Information about gingival indices will be accessible after indistinguishable to patients. When: 6 months after publishing the results To whom: Researchers related to academic and scientific institutions Conditions: Only academic and scientific researchers will be allowed access to research data and can only be used for statistical analysis. Where to obtain: Applicants can receive data if they need the e-mail address of the author responsible for public accountability. How to obtain: As the request, they will be answered by e-mail from the author responsible for public accountability within a month. Comments:
public Sajjad Niroumand
No. 197, Bahar3 Ave.,Bahar Blvd., Quchan Town
Quchan Iran (Islamic Republic of) 9471644899 +98 51 4724 2091 niroumands951@mums.ac.ir Mashhad University of Medical Sciences scientific Nava Naghibi
No. 225, Resalat 9 Ave., Faramarz Blvd., Mashhad Town
Mashhad Iran (Islamic Republic of) 9185775663 +98 51 3761 5597 naghibin@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Generalized gingivitis Gingival index( Loe and Sillness Gingival Index ) 1 or more Bleeding on probing at more than 10 percent of teeth no limit no limit Both Pregnancy The patients under periodontal treatments within 1 month ago Systemic diseases associated with periodontal conditions K05.10 Chronic gingivitis, plaque induced Treatment - Devices Treatment - Devices Control group: After scaling patients' teeth, flossing (Mina brand) will be done twice a day for 4 weeks after brushing by people in the control group. Brushing will be done by Modified bass method and twice a day by Hi Dent brand manual toothbrush. The correct method of brushing and using dental floss will be taught by a trained evaluator. Intervention group: Oral irrigator will be used after brushing in the intervention group. The duration of using the device is twice a day for 4 weeks. Brushing will be done by Modified bass method and twice a day by Hi Dent brand manual toothbrush. The correct method of brushing and using oral irrigator will be taught by a trained dental student. Oral irrigator under the registered name (Waterjet mouth washer with the ability to monitor and control the user's hygienic behavior) has been designed and patented by a private Iranian company (registration number: 72641) ( patent number: 103383). Unlike other existing devices based on mechanical mechanisms and piston performance, this device has been designed and manufactured based on electromechanical system and on centrifuge performance. The power of spraying system is between 10 to 70 psi and beats from 100 to 1000 times per minute according to microcontroller programming. The liquid used in the oral irrigator is distilled water. The method of using oral irrigator in the intervention group is taught that the person places the tip of the device at an angle almost perpendicular to the surface of the teeth and supra gingival on the teeth after brushing by trained evaluator. Percentage of people with gingival index 1 or higher. Timepoint: Measurement of gingival index at the beginning of the study and 14 and 28 days after starting using dental floss and waterjet. Method of measurement: Clinical examination and direct observation of gingival changes. Bleeding on probing in more than 10 percent of teeth. Timepoint: Measurement of Bleeding on probing at the beginning of the study and 14 and 28 days after starting using dental floss and waterjet. Method of measurement: Using the periodontal Williams probe. Generalized or localized gingivitis. Timepoint: Evaluation of gingivitis at the beginning of the study and 14 and 28 days after starting the use of dental floss and waterjet. Method of measurement: Clinical examination and direct observation of gingival changes. Mashhad University of Medical Sciences Approved 2021-12-01 Ethics committee of Mashhad University of Medical Science Beginning of Vakilabad Ave., In front of Mellat Park ., Mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)