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

NCT02418520 | Completed

• 1 other identifier: KSAUHS2015
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To elucidate the relationship of chewing miswak sticks on the H. Pylori infection in the oral cavity.The study would be conducted at the Faculty of Dentistry, Kuwait University. Oral plaque samples would be obtained from those patients who are willing to participate. As a part of the initial screening the plaque samples would be collected and sent for screening of oral microbiota to the Microbiology Department of Faculty of Dentistry, Kuwait University. Here, the basic microbial culturing (rapid urease test) would be performed for detecting the presence of oral H.Pylori. Volunteers who are tested positive for H. Pylori infection through the rapid urease test would be invited to participate in the study.

Conditions

Caries; Periodontitis

Outcome Measures

Primary Outcomes (1)

• The main outcome measure would be the change over time of the microbiologic data, specifically the H.Pylori counts within both groups.

  The main outcome variable would be the change over time of the microbiologic data within both groups. Thus, the change in the number H.Pylori would be compared between the two groups at regular predetermined intervals.The patients would be recalled regularly and their plaque samples would be collected and sent for 16SrRNA gene sequencing. Gene sequencing has been known to provide more accurate information on the species of Helicobacter when compared to other methods.

  6 months

Study Arms (2)

Miswak chewing

EXPERIMENTAL

Chewing Sticks

Device: Miswak

H.Pylori

NO INTERVENTION

Oral H.Pylori

Interventions

Miswak DEVICE

Oral hygiene with Miswak chewing sticks and normal tooth brush

Miswak chewing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged \> 18yrs
• Having \>24 teeth
• Physically/mentally healthy

You may not qualify if:

• None

Sponsors & Collaborators

• Kuwait University: lead

Study Sites (1)

Kuwait University, faculty of dentistry

Kuwait City, 13110, Kuwait

Location

Related Publications (3)

• Rifaey N, AlAdwani M, Karched M, Baskaradoss JK. A clinical investigation into the efficacy of miswak chewing sticks as an oral hygiene aid: A crossover randomized trial. Int J Dent Hyg. 2021 May;19(2):223-230. doi: 10.1111/idh.12484. Epub 2020 Dec 20.

  PMID: 33258168 BACKGROUND

• Aksit Bicak D, Akyuz S, Kiratli B, Usta M, Urganci N, Alev B, Yarat A, Sahin F. The investigation of Helicobacter pylori in the dental biofilm and saliva samples of children with dyspeptic complaints. BMC Oral Health. 2017 Mar 21;17(1):67. doi: 10.1186/s12903-017-0361-x.

  PMID: 28327128 BACKGROUND

• Contractor QQ, Tahir MY, Naseem S, Ahmad S. Helicobacter pylori in the dental plaque of healthy Saudis. Saudi J Gastroenterol. 1998 Jan;4(1):13-6.

  PMID: 19864780 RESULT

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Intervention group would use Miswak chewing sticks along with the regular use of tooth brush and paste

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 16, 2015
• Study Start: October 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

KU (1)