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

NCT04123002 | Completed

• 1 other identifier: FOD6
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Conditions

Gingivitis

Keywords

P.gingivalis; Miswak

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Interventional group

EXPERIMENTAL

Miswak chewing sticks would be provided to the participants and they would be explained the method of use

Other: Miswak chewing sticks

Comparison group

NO INTERVENTION

They would use only tooth brush and paste

Interventions

Miswak chewing sticks OTHER

Chewing stick are routinely used by this population

Interventional group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Patients on antibiotics

Sponsors & Collaborators

• King Saud Bin Abdulaziz University for Health Sciences: lead
• Kuwait University: collaborator

Study Sites (2)

Jagan K Baskaradoss

Kuwait City, Kuwait

Location

Kuwait University, faculty of dentistry

Kuwait City, Kuwait

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 10, 2019
• Study Start: April 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 3, 2020

Record last verified: 2020-12

Locations

KU (2)