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IRCT20090311001760N48 IRCT 2019-09-17 Babol University of Medical Sciences Effect of ozonated water in scaling and root planing Evaluation of the effects of ozonated water in non-surgical patients with chronic periodontitis 2019-08-11 anticipated 30 Complete https://irct.ir/trial/41511 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple randomization, randomization unit: individual, randomization tool: random number table, Blinding description: The first clinician assigns patients randomly to control and intervention groups. The second clinician which is blind toward the treatment, evaluates the clinical parameters. Scaling and root planing procedures are performed by a third clinician, who is blind regarding whether ozonated water or tap water is being used. The follow-up visits are performed by the second clinician, too. 2-3 Chronic periodontitis. Intervention 1: Intervention group: The intervention group receives scaling and root planing (SRP) with ozonated-water. SRP includes full debridement of supragingival and subgingival plaque performed using a DTE D7 ultrasonic device (Made in IR. Iran. by Ozonsazan Pasargad corporation. SS8 Ozone generator). Full SRP is performed in two sessions of 40 minutes long each with a one-week interval in between the sessions. The DTE D7 ultrasonic device consists of a water tank filled with ozonated-water. Based on the half-life of ozone molecules in water, the water tanks are refilled with fresh ozonated-water after 20 minutes. The maximum safe concentration of ozone in water, based on previous studies, is 8 ppm, and its proper concentration in different dentistry treatments, including periodontal non-surgical ones, 1.5 ppm. After the procedure, patients are instructed properly to adhere to oral and dental hygiene. Each patient is followed up in four and eight weeks after the second treatment session. In each follow-up visit, the patient's clinical periodontal status is evaluated by periodontal pocket depth (PPD), clinical attachment level (CAL) and gingival index (GI). Intervention 2: Control group: Patients in the control group receive scaling and root planing (SRP) with tap water. SRP included full debridement of supragingival and subgingival plaque performed using a DTE D7 ultrasonic device. Full SRP is performed in two sessions of 40 minutes long each with a one-week interval in between the sessions. The DTE D7 ultrasonic device with a water tank that is filled with tap water. To ensure that the methods that are used for patients of the control group are seemingly equivocal to those of the intervention group, the water tank is refilled with tap water after 20 minutes, too. 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 No more information.
public Mojan Ghaforui
Babol University of Medical Sciences, Ganj Afrouz St.
Babol Iran (Islamic Republic of) 47176-17745 +98 11 3219 9592 ghafourimojan@gmail.com Babol University of Medical Sciences scientific Dr. Mohadese Yazdanpanah
Faculty of Dentistry, Babol University of Medical Sciences, Ganj Afrouz St.
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 9592 yazdanpanah.mohadese@com.yahoo Babol University of Medical Sciences Iran (Islamic Republic of) Range age of 20-70 years Mild to moderate chronic periodontitis Patient with o’leary plaque index equal or less than 20 20 years 70 years Both Smoking Pregnancy and Lactation Any types of systemic disease like hyperthyroidism, severe anemia, severe myasthenia, acute alcohol poisoning, recent myocardial infarction, active bleeding, etc. Patients who received surgical or non-surgical or antibiotic therapies over the past 6 months. People who should not use ultrasonic devices, including people who has infectious diseases and immune deficiency, those at risk of respiratory diseases. K05.3 Chronic periodontitis Treatment - Drugs Placebo Intervention group: The intervention group receives scaling and root planing (SRP) with ozonated-water. SRP includes full debridement of supragingival and subgingival plaque performed using a DTE D7 ultrasonic device (Made in IR. Iran. by Ozonsazan Pasargad corporation. SS8 Ozone generator). Full SRP is performed in two sessions of 40 minutes long each with a one-week interval in between the sessions. The DTE D7 ultrasonic device consists of a water tank filled with ozonated-water. Based on the half-life of ozone molecules in water, the water tanks are refilled with fresh ozonated-water after 20 minutes. The maximum safe concentration of ozone in water, based on previous studies, is 8 ppm, and its proper concentration in different dentistry treatments, including periodontal non-surgical ones, 1.5 ppm. After the procedure, patients are instructed properly to adhere to oral and dental hygiene. Each patient is followed up in four and eight weeks after the second treatment session. In each follow-up visit, the patient's clinical periodontal status is evaluated by periodontal pocket depth (PPD), clinical attachment level (CAL) and gingival index (GI). Control group: Patients in the control group receive scaling and root planing (SRP) with tap water. SRP included full debridement of supragingival and subgingival plaque performed using a DTE D7 ultrasonic device. Full SRP is performed in two sessions of 40 minutes long each with a one-week interval in between the sessions. The DTE D7 ultrasonic device with a water tank that is filled with tap water. To ensure that the methods that are used for patients of the control group are seemingly equivocal to those of the intervention group, the water tank is refilled with tap water after 20 minutes, too. Periodontal pocket depth. Timepoint: baseline, 4 and 8 week after scaling and root planing (SRP). Method of measurement: William's periodontal probe. Clinical attachment loss. Timepoint: baseline, 4 and 8 week after SRP. Method of measurement: William's periodontal probe. Gingival index. Timepoint: baseline, 4 and 8 week after SRP. Method of measurement: William's periodontal probe. Babol University of Medical Sciences Approved 2018-04-23 Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganj Afrouz St. Babol Mazandaran Iran (Islamic Republic of)