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IRCT201204289582N1 IRCT 2013-12-02 Dental School, Tehran Islamic Azad University Effect of mouthwash on gingival disease Comparative evaluation of salivary substantivity and antiplaque efficacy of mouthwashes containing chlorhexidine, cetylpyridinium chloride and Salvarora Persica in gingivitis patients 2012-12-06 anticipated 16 Complete https://irct.ir/trial/10157 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Other design features: The design of study is cross over and each volunteer in each group with a washout period of 10 days for each mouthwash, will participate in both parts of the study and will use all the studied mouthwashes. The details are presented in the intervention section. N/A prevention of periodontal diseases. Intervention 1: Group 1: First part: Salivary substantivity of mouthwashes: 1- 0.12% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 2- Persica mouthwash, once 10cc for 30 Sec. 3- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, once 10cc for 30 Sec. 4- CPC (Oral-B) mouthwash, once 10cc for 30 Sec. 5- 0.2% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 6- Normal saline, once 10cc for 30 Sec. Group 1: Second part: Four days anti plaque efficacy: 1- 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 2- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 3- 0.12% Chlorhexidine Kin Gingival( Spain)mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 4- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 5- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 6- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days. Intervention 2: Group 2: First part: Salivary substantivity of mouthwashes: 1- Normal saline, once 10cc for 30 Sec. 2- 0.12% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 3- Persica mouthwash, once 10cc for 30 Sec. 4- 0.12% Chlorhexidine Kin Gingival (Spain) once 10cc for 30 Sec. 5- CPC (Oral-B) mouthwash, once 10cc for 30 Sec. 6- 0.2% local Chlorhexidine, once 10cc for 30 Sec. Group 2: Second part: Four days anti plaque efficacy of mouthwash. 1- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days. 2- 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 3- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 4- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 5- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 6- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. Intervention 3: Group 3: First part: Salivary substantivity of mouthwashes: 1- Persica mouthwash, once 10cc for 30 Sec. 2- 0.12% Chlorhexidine Kin Gingival( Spain, once 10cc for 30 Sec. 3- CPC (Oral-B), once 10cc for 30 Sec. 4- 0.2% local Chlorhexidine, once 10cc for 30 Sec. 5- Normal saline once 10cc for 30 Sec. 6- 0.12% local Chlorhexidine. once 10cc for 30 Sec. Group 3: Second part: Four days anti plaque efficacy of mouthwash. 1- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 2- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 3- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 4- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 5- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days. 6- - 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. Intervention 4: Group 4: First part: Salivary substantivity of mouthwashes: 1- 0.12% Chlorhexidine Kin Gingival (Spain) once 10cc for 30 Sec. 2- CPC (Oral-B) mouthwash, once 10cc for 30 Sec., 3- 0.2% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 4- Normal saline once 10cc for 30 Sec. 5- 0.12% local Chlorhexidine, once 10cc for 30 Sec. 6- Persica mouthwash once 10cc for 30 Sec. Group 4: Second part: Four days anti plaque efficacy of mouthwash. 1-0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 2- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 3- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 4- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days. 5- - 0.12% local chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 6- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. Intervention 5: Group 5: First part: Salivary substantivity of mouthwashes: 1- CPC (Oral-B) mouthwash, once 10cc for 30 Sec., . 2- 0.2% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 3- Normal saline, once 10cc for 30 Sec. 4- 0.12% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 5- Persica mouthwash, once 10cc for 30 Sec. 6- 0.12% Chlorhexidine Kin Gingival (Spain) once 10cc for 30 Sec. Group 5: Second part: Four days anti plaque efficacy of mouthwash. 1- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 2- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 3- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days. 4- - 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 5- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. Intervention 6: Group 6: First part: Salivary substantivity of mouthwashes: 1- 0.2% local chlorhexidine mouthwash, once 10cc for 30 Sec. 2- Normal saline, once 10cc for 30 Sec. 3- 0.12% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 4- Persica mouthwash, once 10cc for 30 Sec. 5- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, once 10cc for 30 Sec. 6- CPC (Oral-B) mouthwash, once 10cc for 30 Sec. Group 5: Second part: Four days anti plaque efficacy of mouthwash. 1- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 2- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days. 3- - 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 4- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 5- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
public Mahmood Ghasemi
No:4, 10th Neyestan,Pasdaran Ave.
Tehran Iran (Islamic Republic of) +98 21 2256 4571 m_ghasemi@dentaliau.ac.ir Dentla school, Tehran Islamic Azad University scientific Mahmood Ghasemi
No:4, 10th Neyestan,Pasdaran Ave.
Tehran Iran (Islamic Republic of) +98 21 2256 4571 m_ghasemi@dental.iau.ac.ir Dental school, ،Tehran Islamic Azad University Iran (Islamic Republic of) Inclusion criteria; 18 years and above; minimum of 24 teeth; no partial or fixed prosthesis and not under orthodontic treatment; no gingival sulcus deeper than 3mm; maximum plaque index( Turesky et al) of 2 and gingival index( Loa and Silness) of 1.5 Exclusion criteria: Age above 45 years, not smoker; no antibiotic therapy or routine antiseptic use for past 3 months; allergy to any mouth washes; no patient compliance 18 years 45 years Both k05 Gingivitis and periodontal disease Treatment - Drugs Diagnosis Diagnosis Diagnosis Diagnosis Diagnosis Group 1: First part: Salivary substantivity of mouthwashes: 1- 0.12% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 2- Persica mouthwash, once 10cc for 30 Sec. 3- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, once 10cc for 30 Sec. 4- CPC (Oral-B) mouthwash, once 10cc for 30 Sec. 5- 0.2% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 6- Normal saline, once 10cc for 30 Sec. Group 1: Second part: Four days anti plaque efficacy: 1- 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 2- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 3- 0.12% Chlorhexidine Kin Gingival( Spain)mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 4- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 5- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 6- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days. Group 2: First part: Salivary substantivity of mouthwashes: 1- Normal saline, once 10cc for 30 Sec. 2- 0.12% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 3- Persica mouthwash, once 10cc for 30 Sec. 4- 0.12% Chlorhexidine Kin Gingival (Spain) once 10cc for 30 Sec. 5- CPC (Oral-B) mouthwash, once 10cc for 30 Sec. 6- 0.2% local Chlorhexidine, once 10cc for 30 Sec. Group 2: Second part: Four days anti plaque efficacy of mouthwash. 1- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days. 2- 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 3- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 4- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 5- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 6- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. Group 3: First part: Salivary substantivity of mouthwashes: 1- Persica mouthwash, once 10cc for 30 Sec. 2- 0.12% Chlorhexidine Kin Gingival( Spain, once 10cc for 30 Sec. 3- CPC (Oral-B), once 10cc for 30 Sec. 4- 0.2% local Chlorhexidine, once 10cc for 30 Sec. 5- Normal saline once 10cc for 30 Sec. 6- 0.12% local Chlorhexidine. once 10cc for 30 Sec. Group 3: Second part: Four days anti plaque efficacy of mouthwash. 1- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 2- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 3- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 4- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 5- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days. 6- - 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. Group 4: First part: Salivary substantivity of mouthwashes: 1- 0.12% Chlorhexidine Kin Gingival (Spain) once 10cc for 30 Sec. 2- CPC (Oral-B) mouthwash, once 10cc for 30 Sec., 3- 0.2% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 4- Normal saline once 10cc for 30 Sec. 5- 0.12% local Chlorhexidine, once 10cc for 30 Sec. 6- Persica mouthwash once 10cc for 30 Sec. Group 4: Second part: Four days anti plaque efficacy of mouthwash. 1-0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 2- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 3- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 4- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days. 5- - 0.12% local chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 6- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days Group 5: First part: Salivary substantivity of mouthwashes: 1- CPC (Oral-B) mouthwash, once 10cc for 30 Sec., . 2- 0.2% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 3- Normal saline, once 10cc for 30 Sec. 4- 0.12% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 5- Persica mouthwash, once 10cc for 30 Sec. 6- 0.12% Chlorhexidine Kin Gingival (Spain) once 10cc for 30 Sec. Group 5: Second part: Four days anti plaque efficacy of mouthwash. 1- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 2- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 3- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days. 4- - 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 5- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. Group 6: First part: Salivary substantivity of mouthwashes: 1- 0.2% local chlorhexidine mouthwash, once 10cc for 30 Sec. 2- Normal saline, once 10cc for 30 Sec. 3- 0.12% local Chlorhexidine mouthwash, once 10cc for 30 Sec. 4- Persica mouthwash, once 10cc for 30 Sec. 5- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, once 10cc for 30 Sec. 6- CPC (Oral-B) mouthwash, once 10cc for 30 Sec. Group 5: Second part: Four days anti plaque efficacy of mouthwash. 1- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 2- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days. 3- - 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 4- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. 5- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days. Number of vital bacteria. Timepoint: before and after 30 second; 1; 3; 5 and 7 hours of single use of 10cc of mouthwash for 45 seconds. Method of measurement: Epiflourescence. Bacterial Plaque. Timepoint: 4 days after use. Method of measurement: Turesky Plaque Index. Change in taste sensation. Timepoint: 4 days. Method of measurement: Visual Analog Scale. Burning sensation. Timepoint: 4 days. Method of measurement: Visual analog Scale. Presence of stain. Timepoint: 4 days. Method of measurement: Observation. Dental School, Tehran Islamic Azad University Approved 2011-10-04 Ethical Commitee,Deputy of Research , Dental school , Tehran Islamic Azad University No:4; 10th Neyestan; Pasdaran Ave Tehran Iran (Islamic Republic of)