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IRCT20220409054462N1 IRCT 2022-05-22 Kashan University of Medical Sciences The Effectiveness Comparison of Aloe vera، Povidone Iodine and Chlorhexidine Mouthwashes in the Treatment of Patients with inflamed Gums The Effectiveness Comparison of Aloe vera، Povidone Iodine and Chlorhexidine Mouthwashes in the Treatment of Patients with Gingivitis 2022-05-22 anticipated 27 Complete https://irct.ir/trial/63020 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Photographs are also taken of patients before and after the intervention, which can help assess how the Gums are healing. It should be noted that Individuals are evaluated to enter the study through Periodontal Risk Assessment software and Individuals with Medium risk and higher are involved in the intervention. both Jaws are examined separately for Indicators, Randomization description: The Subjects will be randomly divided into Three Groups receiving Chlorhexidine, Betadine and Aloevera. Thus, due to the Gradual Referral of Patients and to maintain the Balance of Individuals in Groups, Individuals are randomly selected by Permuted Block Randomization with Triple Blocks. Thus, based on Random Numbers obtained from SPSS Software, one of the Blocks with Sequence of ; CBA, CAB, BCA, BAC, ACB, ABC is selected. The letter A means the Person assigned to the Aloevera Group, the letter B means the Person assigned to the Betadine Group, and the letter C means the Person assigned to the Chlorhexidine Group. The Mouthwashes are delivered to Patients in Black Bottles with Labels of A, B, and C, Blinding description: The Therapist delivers the Triple Blocks provided by the Software to the Ward Secretary, and the Mouthwashes are delivered to the Patients along with the Label, following the Blocks, by the Secretary to the Patients. The Statistical Consultant does not know the Names of Mouthwashes in Groups A, B, and C. 2 Gingivitis. Intervention 1: First intervention group: Aloe vera Mouthwash was assigned to this Group. In this study, 120 ml of Aloe vera Mouthwash Syrup produced by the Company of Barij Esans Kashan is used. which contains 2.5 mg of Glaucoma (Sugar of Konjac Plant) in every 5 ml of Syrup and with a concentration of 50%, the rest is composed of Honey. Patients rinse 10 ccs of this Mouthwash once a Day, before going to bed, for one Month, and then pour it out. Intervention 2: Second intervention group: Betadine Mouthwash was assigned to this Group. It is a Solution of Iodine and Polyvinyl Pyrrolidone in Molecular form. A solution of 250 ml of 10% Betadine produced by Behsa Company is used for this purpose. It is then diluted with a graduated Cylinder in a ratio of 9 Water to 1 Betadine to achieve the desired concentration of 1%. Patients rinse 10 ccs of this Mouthwash once a Day, before going to bed, for one Month and then pour it out. Intervention 3: Third Intervention group: Chlorhexidine Mouthwash assigned to this Group is a Cationic Bisbiguanide with a wide range of functions. In this study, a 250 ml Solution produced by Behsa Company with a Concentration of 0.2% is used. To achieve a Dose of 20 mg, Patients are asked to rinse their Mouths with 10 ml of 0.2% Chlorhexidine Mouthwash for 30 seconds for one Month and every Night before Bed and then pour it out. 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 There is no more information
public Sara Ebrahimi
Third Kilimeter of Qotb Ravandi Ave., Pezeshk Blvd
Kashan Iran (Islamic Republic of) 8715981151 0098 21 555431 sara_ebrahimi64@yahoo.com Kashan University of Medical Sciences scientific Sara Ebrahimi
Third Kilometer of Qotb Ravandi Ave., Pezeshk Blvd
Kashan Iran (Islamic Republic of) 8715981151 0098 21555431 sara_ebrahimi64@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) having at least 20 Teeth in the Mouth regardless of Third Molar Bleeding on Probing Having no Sensitivity to the Mouthwashes that exist in the intervention Absence of Periodontit Absence of Clinical Attachment loss Age over 20 years 20 years 55 years Both Undergoing Periodontal Treatment in the past 6 months Systemic diseases such as Diabet، Radiotherapy، Cancer and Hyperthyroidism With Mental or Physical Retardation that could have influenced the Oral Hygiene Presence of Periodontal Pockets Pregnancy K05.1 Chronic gingivitis Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group: Aloe vera Mouthwash was assigned to this Group. In this study, 120 ml of Aloe vera Mouthwash Syrup produced by the Company of Barij Esans Kashan is used. which contains 2.5 mg of Glaucoma (Sugar of Konjac Plant) in every 5 ml of Syrup and with a concentration of 50%, the rest is composed of Honey. Patients rinse 10 ccs of this Mouthwash once a Day, before going to bed, for one Month, and then pour it out. Second intervention group: Betadine Mouthwash was assigned to this Group. It is a Solution of Iodine and Polyvinyl Pyrrolidone in Molecular form. A solution of 250 ml of 10% Betadine produced by Behsa Company is used for this purpose. It is then diluted with a graduated Cylinder in a ratio of 9 Water to 1 Betadine to achieve the desired concentration of 1%. Patients rinse 10 ccs of this Mouthwash once a Day, before going to bed, for one Month and then pour it out. Third Intervention group: Chlorhexidine Mouthwash assigned to this Group is a Cationic Bisbiguanide with a wide range of functions. In this study, a 250 ml Solution produced by Behsa Company with a Concentration of 0.2% is used. To achieve a Dose of 20 mg, Patients are asked to rinse their Mouths with 10 ml of 0.2% Chlorhexidine Mouthwash for 30 seconds for one Month and every Night before Bed and then pour it out. Determination and Comparison of total and mean Gingival Index score in three Groups receiving Mouthwashes (Aloe vera, Betadine and Chlorhexidine) before and after Treatment. Timepoint: A month after the intervention. Method of measurement: To measure the Gingival Index by looking at the Gingival soft tissue, a score of zero to three is given to each of the four areas of the Gingival Soft Tissue of each Tooth. The Scores from the four areas of the Tooth are added together and divided by four to obtain a Specific Gingival Index for each Tooth. The average of Gingival Index is obtained by dividing the Total Gingival Index Score of all Teeth by the Number of Teeth. Each score should have several specific characteristics that are different from the other Score so that the Therapist can easily Determine the score. Zero Grade means Normal Gingival Tissue: Pink or Pale Pink, varying degrees of Stippling, Placement of the Gingival margin on the Enamel or at different levels more apical than Cemento Enamel Junction, firm Gingival Tissue when touched by the Periodontal Probe Grade 1 means Mild Inflammation: Mild Discoloration, slightly reddish Gingival margin, slight Swelling, accumulation of colorless Exudate in the Gingival Margin, no Bleeding during Probing Grade 2 means Moderate inflammation: Red or Blue-red Gingival Tissue Color Glossy, increased Gingival margin due to swelling, Bleeding during Probing grade 3 means Severe inflammation: Marked redness and swelling, Sores, tendency to Bleed spontaneously Examination of all Tooth Surfaces for the Gingival Index begins with the upper right Second Molars and continues to the Midline and upper left Second Molars. The order of Examination on the right starts from the Distal and then the Buccal and Mesial are evaluated. The order of Examination on the left starts from the Mesial and then the Buccal and Distal are examined. After examining all three Mesial, Buccal, and Distal Surfaces, evaluation of the Palatal Surface of the Maxillary Teeth starts from the left second Molar. Examination of the Mandible begins at the left second Molar and continues toward the right Second Molar. The order of Examination on the left is first Distal, then Buccal and Mesial, and on the right is first Mesial, then Buccal and Distal, and finally the lingual Surface is evaluated from the Second left Molar. Mild Inflammation Scores range from 0.1 to 1; Moderate Inflammation is from 1.1 to 2 and severe Inflammation is from 2.1 to 3. Determining and Comparing Sulcular Bleeding Index score in three Groups receiving Mouthwashes (Aloe vera, Betadine and Chlorhexidine) before and after Treatment. Timepoint: A Month after the intervention. Method of measurement: Factors such as Marginal Gingival and papillary swelling with or without Ulceration, Marginal Gingival and Papillary Discoloration, and Bleeding during Probing are important in determining the Sulcular Bleeding Index score, so that a score of 0 indicates papillae and a Healthy marginal gingiva score of 1 indicates Bleeding during Probing, without Discoloration and swelling of Papillae and Marginal Gums score 2 indicates Discoloration and Bleeding during probing, without Gingival swelling score 3 related to Discoloration and Bleeding during probing and slight swelling of the Gums A score of 4 indicates Discoloration and Bleeding during probing and marked swelling of the Gums. A score of 5 indicates Discoloration and Spontaneous Bleeding during probing, a marked swelling that may or may not have Ulcer In the study of Sulcular Bleeding Index, each Jaw is examined separately and is divided into three Sextants. In each Sequence, the Buccal and Lingual Gums are examined separately, and each one that received a higher score is considered as the main score of the Sequence and is compared to the main score of the other two Sextants obtained in the same way. In each Jaw, any Sequence that has a higher score will be compared to subsequent Sessions to evaluate the quality of the intervention. Comparison of Bleeding Differences when brushing (Gingival Bleeding on Brushing) in three Groups receiving Mouthwashes (Aloe vera, Betadine and Chlorhexidine), before and after Treatment. Timepoint: A Month after the intervention. Method of measurement: This Indicator is an important Sign for the Presence or Absence of Gingivitis or Periodontitis, and realizing it can increase People's self-awareness about Gum Health and effective and timely Solutions can be adopted for Treatment. This Index is higher in Gingivitis Patients and is associated with inflammatory lesions. In this Study, People are asked about bleeding when brushing before scaling, and the same Question is repeated after the Intervention. If the Patient states in the first Session that there is no bleeding while brushing, the Evaluation will depend on the Sulcular Bleeding Index and Gingival Index. Evaluation and Comparison of Mouthwash Solutions in terms of Complications (Tooth Discoloration, bad Breathing and Irritation) after the intervention. Timepoint: A month after intervention. Method of measurement: Patients are asked about the feeling of Change in the Taste and Smell of the Mouth or Burning after using Mouthwashes. Also, using Photographs and asking patients, the amount of discoloration of the Teeth is assessed because in the First Session scaling is done for all Patients. And Discoloration of the Teeth after a Month can indicate the Effect of Mouthwashes. Kashan University of Science Approved 2022-01-26 Ethics committee of Kashan University of Medical Sciences No. 25, West Shahid Amini Nezhad Ave or West Haft dast Ave.,Chahar Bagh Bala Ave., Esfahan City Esfahan Isfehan Iran (Islamic Republic of)