Effect of Miswak Chewing Sticks on Periodontal Pathogens and Its Impact on the Progression of Gingivitis

Effect of Miswak on P.Gingivalis

A cross over randomized clinical trial Group A- Tooth Brush and Paste only Group B- Tooth Brush and Paste and Miswak chewing sticks

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Other: Miswak chewing sticks

Detailed Description

The study design would be a cross over randomized clinical trial. The study sample would be selected from the regular dental patients visiting the Faculty of Dentistry, Kuwait University, Kuwait. The subjects of our study are patients with >24 teeth who are physically/mentally healthy and those who were diagnosed with gingivitis. There will be an initial screening of the subjects, where patients would be briefed on the study components and informed consent would be obtained from those who are willing to participate in this study. The study subjects would be randomly divided into two groups; Group 1 subjects would be instructed to brush their teeth two times per day, in the morning and in the evening before going to the bed, and to refrain from using a miswak during this period. Group 2 subjects would receive the same instructions as Group 1 subject, but, in addition, they would also be instructed to use miswak chewing sticks two times a day. All the participants would then be given instructions on how to use miswak and toothbrush by the investigators. A sample size of 20 was considered sufficient to conduct this study. The socio-demographic details of the study participants would be obtained from the electronic dental records. Plaque index and gingival bleeding index would be taken at baseline and on day 14. Plaque samples would be collected at baseline - before and after the intervention (tooth brushing/miswak), day 3, day 7 and day 14. The oral plaque samples would be sent for PCR analysis.

Randomized assignment of the subjects regarding the order of miswak and toothbrush would be carried out, by a random binary outcome of a dice, even or odd numbers. Group 1 subjects would be given a new toothbrush (regular, straight handled Oral-B toothbrush). Group 2 subjects would also be given a new toothbrush (regular, straight handled Oral-B toothbrush) as well as 14 fresh sticks of miswak (20 cm in length and 7mm in width) to be used daily. Then the groups would be crossed over.

Sample collection procedure and Purification of Microbes Subgingival and supragingival plaques samples would be collected using a sterile universal curette. Subgingival plaque samples would be collected from the deepest periodontal pocket. The sampling area would be isolated from saliva and gently dried with air. The point would be then immersed in 0.5 ml sterile distilled water in Eppendorf tubes (epTIPS Standard, Eppendorf AG, Hamburg, Germany). The collected samples would be then sent to the Microbiology Laboratory, Faculty of Dentistry, Kuwait University and PCR analysis would be conducted to identify the strains.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kuwait
  • Kuwait City, Kuwait
    • Jagan K Baskaradoss
  • Kuwait City, Kuwait
    • Kuwait University, faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The subjects of our study are patients with >24 teeth who are physically/mentally healthy
• Those who were diagnosed with gingivitis. There will be an initial screening of the subjects, where patients would be briefed on the study components and informed consent would be obtained from those who are willing to participate in this study

Exclusion Criteria:

• Patients on antibiotics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; Miswak chewing sticks would be provided to the participants and they would be explained the method of use	Other: Miswak chewing sticks; Chewing stick are routinely used by this population
No Intervention: Comparison group; They would use only tooth brush and paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The gingival health of index teeth as measured using a standardized index	Gingival health would be measured using Loe and Silness gingival index	2 weeks

Collaborators and Investigators

• Sponsor: King Saud Bin Abdulaziz University for Health Sciences
• Collaborators: Kuwait University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Miswak; P.gingivalis
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: FOD6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No