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

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ClinicalTrials.gov Identifier: NCT04123002
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Kuwait University
Information provided by (Responsible Party):
Dr Jagan K Baskaradoss, Kuwait University

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

Condition or disease Intervention/treatment Phase
Gingivitis Other: Miswak chewing sticks Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Study participants would be divided into 2 groups. Group A would received tooth brush and paste and Group B would receive Miswak chewing stick along with tooth brush and paste. They would be instructed to use the assigned oral hygiene aid for a week. Then the groups would cross-over and continue for 1 week. Plaque and gingival measures would be taken at baseline, end of week 1 and end of week 2.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Miswak on P.Gingivalis
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

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



Primary Outcome Measures :
  1. The gingival health of index teeth as measured using a standardized index [ Time Frame: 2 weeks ]
    Gingival health would be measured using Loe and Silness gingival index



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123002


Contacts
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Contact: Jagan K Baskaradoss 0096599671210 drjaganb@gmail.com

Locations
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Kuwait
Jagan K Baskaradoss Completed
Kuwait City, Kuwait
Kuwait University, faculty of dentistry Recruiting
Kuwait City, Kuwait
Sub-Investigator: Noha AlRefai         
Sub-Investigator: Manar Adwani         
Sponsors and Collaborators
King Saud Bin Abdulaziz University for Health Sciences
Kuwait University

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Responsible Party: Dr Jagan K Baskaradoss, Assistant Professor, Kuwait University
ClinicalTrials.gov Identifier: NCT04123002     History of Changes
Other Study ID Numbers: FOD6
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Jagan K Baskaradoss, Kuwait University:
P.gingivalis
Miswak
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases