The Effect of Miswak Chewing Sticks on the Oral Helicobacter Pylori Infection

Ethical aspects The experimental protocol was approved by the Health Science Center (HSC) ethical committee of Kuwait University (VDR/ED/3331) and is registered at ClinicalTrials.gov as NCT02418520 (16/04/2015). Research was conducted according to the principles outlined in the declaration of Helsinki on human medical experimentation. Written informed consent was obtained from all participants and is presented in accordance to the consolidated standards of reporting trials (CONSORT) guidelines.

Study Design This was an experimental study with a randomized, cross-over, single blind design.

Study sample and Data collection This study was conducted among regular patients attending the Dental Center at Kuwait University, Kuwait. Patient recruitment started in February and was completed by the end of August 2019. The PICO (P = Patient population; I = Intervention of interest; C = Comparative intervention; O = Outcome) question for this study was, "for subjects under different fasting conditions (P), what is the effect of using miswak chewing sticks along with toothbrush (I) versus using only toothbrush (C) on the oral H. pylori counts (O)?". Volunteering patients were briefed on the study components and informed consent was obtained from them. Salivary and plaque samples were collected for PCR screening to detect the presence of H. pylori. The inclusion criteria were: 1) subjects with detectable levels of H. pylori in either plaque or salivary samples; 2) no evidence of periodontitis; and, 3) with at least 24 teeth. Subjects who received antibiotic therapy or proton-pump inhibitors within the past three months were excluded from the study.

Recruitment of study participants and grouping This study included 20 subjects who were on 12-hour fasting (fasting group) and 20 subjects who were not fasting (non-fasting group). Non-fasting group subjects were recruited between February and April and fasting group subjects were recruited between May and June 2018 (holy month of Ramadan). At baseline (T0), each subject was assigned numbers based on the chronological order of enrolment in the study. Both, the fasting and the non-fasting subjects were randomly subdivided into Group-1 and Group-2 (n=10 each). Randomized assignment of the subjects was carried out by a random binary outcome of a dice, even or odd numbers. The examiners were kept unaware of the participant allocation. Group-1 subjects were instructed to use both toothbrush and miswak (TB+M) for two weeks (T1) and only toothbrush (TB) for the next two weeks (T2); and, Group-2 subjects were asked to use only TB during T1 and TB+M during T2, for both the fasting and the non-fasting groups. Participants were given instructions on how to use miswak (five finger-grip, scrub technique, for 15 mins, twice daily21) and TB (modified Bass technique, for two minutes, twice daily) by a single investigator (JKB). Plaque and salivary samples were collected at T0, T1 and T2.

Questionnaire The subjects were interviewed and information were collected on their socio-demographic characteristics (age, gender, education, employment and income), presence of selected medical conditions (hypertension, diabetes and current medications), smoking status and dental characteristics (daily brushing frequency and previous dental visit).