GingivitisNCT04123002
Effect of Miswak Chewing Sticks on Periodontal Pathogens and Its Impact on the Progression of Gingivitis
A study testing Miswak chewing sticks in people with Gingivitis, run by King Saud Bin Abdulaziz University for Health Sciences at 2 sites in Kuwait.
Trial summary
A cross over randomized clinical trial Group A- Tooth Brush and Paste only Group B- Tooth Brush and Paste and Miswak chewing sticks Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Miswak chewing sticks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesKuwait
- Study dates
- 1 Apr 2019to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients on antibiotics
Trial locations and contacts
2 sites in 1 country.
Kuwait2 sites
Jagan K Baskaradoss
Kuwait City
Kuwait University, faculty of dentistry
Kuwait City
About this study
Official title: 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
Read the 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.
- Conditions
- Gingivitis
- Being tested
- Miswak chewing sticks
- Keywords
- P.gingivalis, Miswak
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miswak chewing sticksOther
Chewing stick are routinely used by this population
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Miswak chewing sticks would be provided to the participants and they would be explained the method of use Receives: Other: Miswak chewing sticks |
| Comparison group | No intervention | They would use only tooth brush and paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
The gingival health of index teeth as measured using a standardized index
Gingival health would be measured using Loe and Silness gingival index
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Apr 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud Bin Abdulaziz University for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Kuwait University
- Responsible party
- Principal investigator, Dr Jagan K Baskaradoss, Kuwait University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123002
- Sponsor's protocol ID
- FOD6
- Status last verified
- Dec 2020
- First submitted
- 3 Oct 2019
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Miswak on P.Gingivalis
- ClinicalTrials.gov ID
- NCT04123002
- Acronym / sponsor ID
- FOD6
- Conditions
- Gingivitis
- Keywords
- P.gingivalis, Miswak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- King Saud Bin Abdulaziz University for Health SciencesUniversity, hospital or other
- Collaborators
- Kuwait University
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Miswak chewing sticksMiswak chewing sticks would be provided to the participants and they would be explained the method of use |
| Comparison group | No intervention | –They would use only tooth brush and paste |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients on antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miswak chewing sticksChewing stick are routinely used by this population | Other | Interventional group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miswak chewing sticks in people with Gingivitis, run by King Saud Bin Abdulaziz University for Health Sciences at 2 sites in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The gingival health of index teeth as measured using a standardized index (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.