Comparison Between the Effect of Triclosan Toothpaste and Chlorhexidine Mouthwash on Gingival Health in a Group of Fixed Orthodontic Patients: A Randomized Controlled Clinical Trial

Gingival Inflammation

Study Protocol Introduction Title of the research study Comparison Between the effect of Triclosan Toothpaste and chlorhexidine Mouthwash on Gingival Health in Fixed Orthodontic Patients :A randomization controlled clinical trial. Background Orthodontic brackets and elastics might interfere with effective removal of dental plaque, thereby increasing the risk of gingivitis. The aim of this study to compare the effect of triclosan toothpaste and chlorhexidine mouthwash on gingival health in a group of fixed orthodontic patients. Procedures Participant eligibility will be assessed based on a dental examination, medical history and inclusion and exclusion criteria. Inclusion criteria: * Patient age 18-35 years old. * Orthodontic patient in leveling and alignment stage. * Interested, cooperative fixed orthodontic patients who are aware of the importance of using toothpastes and mouthwash during orthodontic treatment. * Patients who have good oral hygiene during orthodontic treatment. * Medically fit patients who are not using any medical treatment that may affect periodontal health such as (antibiotic, phenytoin). * Class I, II, III malocclusion with mild to moderate crowding. Exclusion criteria: * Patients with systemic disease affecting periodontal health such as (lichen planus, pemphigus) * Smoker patients. * Chewing qat patients. Eligible participants will be randomly assigned to one of three groups Group 1: will use Colgate Total® toothpaste containing sodium fluoride 0.24% and Triclosan 0.3% for one month twice a day. Group 2: will use Maxfresh ® toothpaste containing sodium fluoride 0.24% in addition to Hexadyl® Chlorhexidine mouthwash for one month twice a day. Group 3: will brush their teeth by Colgate Maxfresh ® toothpaste containing sodium fluoride 0.24% for 3 month twice a day. The participant will be instructed to brush and rinse his or her teeth twice a day and they must follow orthodontic treatment instructions to maintain the braces. The study will last for three month.

3.2 Study population The study population will include fixed orthodontic patients who visit the dental clinics in the College of Dentistry, University of Science and Technology, Sana'a University, and private dental clinics. 3.3 Sample size In this study, the sample size will be determined using a power calculation based on a previous study (Alavi et al. 2018). Their study found a significant difference in the dental plaque index between the Chlorhexidine and fluoride groups (0.003±0.06 vs. 0.249±0.21). To achieve a power of 80% and confidence interval of 95%, the study will need to include 7 participants in each group (https://www.openepi.com/SampleSize/SSPropor.htm).To increase the reliability of the study and to make comparisons with previous similar studies, a total of 10 participants will be included in each group. This will result in a total sample of 60 participants in the study. Triclosan group (10 male, 10 female), CHX group (10 male, 10 female) and Controlled group (10 male, 10 female). 3.4 sample selection 3.4.1 Inclusion criteria: * Patient age 18-35 years old. * Interested, cooperative fixed orthodontic patients who are aware of the importance of using toothpastes and mouthwash during orthodontic treatment. * Patients who have good oral hygiene during orthodontic treatment. * Medically fit patients who are not using any medical treatment that may affect periodontal health such as (antibiotic, phenytoin). * Class I, II, III malocclusion with mild to moderate crowding. 3.4.2 Exclusion criteria: * Patients with systemic disease affecting periodontal health such as (lichen planus, pemphigus) * Smoker patients. * Chewing qat patients. 3.5 study groups: The participants will be selected according to inclusion &exclusion criteria and they will be divided in to three groups and will be given instructions as follows: * Group I (Triclosan group): will brush their teeth by Colgate Total® toothpaste containing sodium fluoride 0.24% and Triclosan 0.3% for 3 month twice a day. * Group II (CHX group): will brush their teeth by Colgate maxfresh ® toothpaste containing sodium fluoride 0.24% in addition to Hexadyl® Chlorhexidine mouthwash for 3 month twice a day. * Group III (Controlled group): will brush their teeth by Colgate maxfresh ® toothpaste containing sodium fluoride 0.24% for 3 month twice a day. The selected toothpaste and mouthwash will be provided for all participants free of charge. 3.6 Clinical examination, Measurement, procedure: Clinical examination will be performed for Triclosan group and CHX group participants in dental unit. Teeth and gingiva will be dried and examined under adequate light, using a mouth mirror and periodontal probe. Before the beginning of examination, all of the selected participants will be instructed on tooth brushing technique (bass technique) and flossing. Scaling and polishing will be performed 2 weeks prior to the beginning of the study. Patients who will fail to maintain good oral hygiene will be excluded from the study. The measurement will be done on teeth selected according to the proposal method for plaque index, gingival index. Patients should brush and rinse their teeth twice a day and they must follow orthodontic treatment instructions to maintain their fixed orthodontic appliance. Each patient will be informed to brush twice daily with the assigned toothpaste and will be provided with a follow up chart each visit where the dentist will assess the compliance of the patients. The patients will mark in the follow up chart each time they brush their teeth. 3.6.1 follow up time: To detect a clinically meaningful reduction in plaque index from baseline to 3 months among the study groups (Boneta A, Aguilar M, Romeu F, Stewart B, DeVizio W, Proskin H.) clinical examination will be in three period of time: Initial examination (T0): will be performed at the beginning of the study, before orthodontic treatment and after scaling and polishing and oral hygiene instruction. First examination (T1): will be performed 1 month after fixed orthodontic appliance is inserted. Secondary examination (T2): will be performed 2 months after fixed orthodontic appliance is inserted. Final examination(T3): will be performed 3 months after fixed orthodontic appliance is inserted. 3.6 Randomization This study will be a randomized controlled clinical trial design to compare between Triclosan toothpaste and Chlorhexidine mouthwash on gingival health. The sample will be randomly divided into three groups by using the sealed envelope technique to achieve random allocation to the study groups. Each envelope will be numberd from 1 to 60 and papers will be written to be inserted inside the envelope with the name of each group (Triclosan group, CHX group or controlled group) according to the number of samples for each group (20 paper for Triclosan group ,20 paper for CHX group 20 paper for controlled group). Each participant will choose an envelope and the assistant will record each participant's result and keep it in list to know the participants of each group and give each participant the necessary instructions for his/her group. 3.7 Blinding This study will be double-blind study the researcher and statistician will not be able to know who the participants are in each group. There will be a supervisor to help in divide the groups, give instruction, and record the results. participants will be aware of the product being used because it is difficult to hide the toothpaste and mouthwash containers. This rigorous approach reduces potential biases and enhances the scientific validity of the study.

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