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IRCT2015022521195N2 IRCT 2015-06-29 Shiraz University of Medical Sciences, International Branch The effectiveness of systematic tinidazole in the treatment of periodontitis in smokers Assessing the effectiveness of systemic Tinidazole as an adjunct to non-surgical periodontal therapy in the treatment of chronic periodontitis in smokers 2014-12-22 anticipated 60 Complete https://irct.ir/trial/18637 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Participants in the test group received 2g tinidazole as loading dose in the first day and then Participants in the test group received 500 mg tinidazole to be taken once daily for 6 days. Participants in the control group received similar looking placebos prepared at the College of Pharmacy ,shiraz. The treatment group was masked from the patient, clinical examiner, operator, and statistician. Student’s t test was the statistical test used for comparing differences in PI, BI,GI, PD, Recession and CAL between the two groups .To compare the differences in various parameters within each group, paired t test was used. The level of significance (a) was taken as 0.05, and the confidence intervals (CIs) were set at 95%. P <0.05 was taken as statistically significant. N/A Moderate to advanced periodontitis in smokers. Intervention 1: In the control proup after measuring the indexes and doing SRP we give placebo to the patiants ,for the first day 4 tablets then thy use 1 tablet per day for 6 days. Intervention 2: Participants in the intervention group received 2g tinidazole as loading dose in the first day and then Participants in the test groupreceived 500 mg tinidazole to be taken once daily for 6 days.
public Armaghan Tarjan
Nader Kazemi clinic, Valiasr square
Shiraz Iran (Islamic Republic of) 71546-14111 +98 71 3229 7390 armaghant70@yahoo.com; tarjan@sums.ac.ir Shiraz University of Medical Sciences, International Branch scientific Dr. Farin Kiany
Dentistry department, Ghom abad
Shiraz Iran (Islamic Republic of) 71956-15878 +98 71 3626 3193 farinkiany@yahoo.com Dentistry Department, Shiraz University of Medical Sciences, International Branch Iran (Islamic Republic of) sixty systemically healthy individuals with untreated moderate-to-advanced periodontitis were recruited into the study based on the following criteria: 1)patients do not use antibiotics in last 2 months. 2)do not have periodontal disease in last 6 months. 3)do not have systematic disease including: diabetes, hypertension, heart disease and other infectious diseases 4)participants should be current smokers(are defined as persons who had smoked at least 100 cigarettes in their lifetime and reported that they were smoking at the time of interview. Exclusion criteria: 1) pregnancy or lactation; 2) systemic diseases (such as diabetes mellitus); 3) systemic antibiotics taken within the previous 2 months; 4) use of non-steroidal anti-inflammatory drugs; 5) confirmed or suspected intolerance to 5-nitroimidazole derivatives; and 6) subgingival SRP or surgical periodontal therapy in the previous 6 month. no limit no limit Both XXI Factors influencing health status and contact with health services Placebo Treatment - Drugs In the control proup after measuring the indexes and doing SRP we give placebo to the patiants ,for the first day 4 tablets then thy use 1 tablet per day for 6 days Participants in the intervention group received 2g tinidazole as loading dose in the first day and then Participants in the test groupreceived 500 mg tinidazole to be taken once daily for 6 days.. GI Leo and Silness was measured. Timepoint: Baseline visit and six weeks later. Method of measurement: According to the color of gingiva and use of probe. PI Oleary was measured. Timepoint: Baseline visit and six weeks later. Method of measurement: By disclosing tablet. Before scaling and root planning , Strict oral hygiene instructions (OHI) were instituted on all participants at the same time by the operator. Timepoint: Baseline visit and six weeks later. Method of measurement: Measured by use of Williams probe. Recession and PD recorded in all present teeth in six sites (mesio-buccal, midbuccal, disto-buccal, mesio-palatal/lingual, mid-palatal/ lingual, and disto-palatal/lingual) in each patient of both groups by the same person.disclosing tablets was used for evaluating PI in four surfaces of teeth(mesial, distal, buccal,lingual/palatal).BI lenox was measured in four sites (mesial, distal, mid buccal and mid palatal/lingual) in all present teeth.GI index evaluated in six teeth(mandibular first molar,first premolar ,central incisors and maxillary first molar ,first premolar and cetral incisors). BI Lenox was measured. Timepoint: Baseline visit and six weeks later. Method of measurement: By using probe. Attachment level was measured. Timepoint: Baseline visit and six weeks later. Method of measurement: PD+ recession. Recession was measured. Timepoint: Baseline visit and six weeks later. Method of measurement: By using probe. PD measured. Timepoint: Baseline visit and six weeks later. Method of measurement: By probing. Shiraz University of Medical Sciences, International Branch Approved 2014-10-11 Shiraz University of Medical Sciences, International Branch Dentistry department, Valiasr square, next to the Nader Kazemi clinic Shiraz Iran (Islamic Republic of)