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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

Tracking Information
First Submitted Date  ICMJE October 3, 2019
First Posted Date  ICMJE October 10, 2019
Last Update Posted Date October 10, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Miswak Chewing Sticks on Periodontal Pathogens and Its Impact on the Progression of Gingivitis
Official Title  ICMJE Effect of Miswak on P.Gingivalis
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Gingivitis
Intervention  ICMJE Other: Miswak chewing sticks
Chewing stick are routinely used by this population
Study Arms  ICMJE
  • Experimental: Interventional group
    Miswak chewing sticks would be provided to the participants and they would be explained the method of use
    Intervention: Other: Miswak chewing sticks
  • No Intervention: Comparison group
    They would use only tooth brush and paste
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jagan K Baskaradoss 0096599671210 drjaganb@gmail.com
Listed Location Countries  ICMJE Kuwait
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04123002
Other Study ID Numbers  ICMJE FOD6
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Jagan K Baskaradoss, Kuwait University
Study Sponsor  ICMJE King Saud Bin Abdulaziz University for Health Sciences
Collaborators  ICMJE Kuwait University
Investigators  ICMJE Not Provided
PRS Account King Saud Bin Abdulaziz University for Health Sciences
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP