Dental PlaquePhase 4NCT04561960
Efficacy of Miswak in Oral Hygiene Maintenance
A Phase 4 study testing Fluoride toothpaste, Toothpaste Product and Toothbrush in people with Dental Plaque, run by Riyadh Elm University at 1 site in Saudi Arabia.
Trial summary
Miswak has been recommended by world health organization for oral hygiene because of its availability, beneficial effect and affordability. The popularity of Miswak in Arab countries has meant that there have been several studies that have confirmed the ability of miswak to provide effective mechanical and chemical… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Fluoride toothpaste, Toothpaste Product and Toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Sep 2020to 30 Dec 2020
- Phase
- Phase 4
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
- Able to perform their own oral hygiene
- Dental students
Who cannot join
- Active Dental Caries
- Uncontrolled chronic medical conditions
- History of drug and/or treatment that reduces salivary flow
- Currently undergoing orthodontic treatment
- Missing index teeth #16, #12, #24, #36, #32, #44
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Miswak When Compared to Fluoridated Toothpaste for the Maintenance of Oral Hygiene in Young Adults
Miswak has been recommended by world health organization for oral hygiene because of its availability, beneficial effect and affordability. The popularity of Miswak in Arab countries has meant that there have been several studies that have confirmed the ability of miswak to provide effective mechanical and chemical cleansing when used as an adjunct to other oral hygiene aids.
Fluoridated tooth paste and manual tooth brushes have been the standard of clinical preventive dental care for over 50 years.However, the objection to the use of fluorides by some parents has meant that these pastes are not universally accepted.
Read more
There are several non-fluoridated pastes available in the market that include the extract of miswak. There are few studies that have compared these pastes to fluoridated pastes and to miswak as a stand alone agents.
Miswak has been recommended by world health organization in 1987 for oral hygiene because of its availability, beneficial effect and affordability.
It has been stated that "Several clinical studies have confirmed that the mechanical and chemical cleansing efficiency of miswak chewing sticks are equal and at times greater than that of the toothbrush" this was mentioned and reviewed that it is in fact right but only when used in a regular constant matter with a proper and effective way of plaque removal. This study aims to use a cross over model to study the effectiveness of miswak as a stand alone agent in maintaining oral hygiene in young adults and compare it miswak containing toothpastes and fluoridated toothpastes when used with a manual tooth brush.
Read the detailed description
Oral hygiene is the key of maintaining human's mouth at a state of equilibrium and free of diseases (e.g. cavities, dental decay, gingivitis, halitosis). Poor oral hygiene can significantly affect the quality of life and has a considerable influence on diet, sleeping, social communication, psychological status, and by being less productive at work.
Therefore, oral hygiene is essential for general health and well-being. Oral hygiene measures include toothbrush which is the most commonly used method for plaque control. However, miswak is a commonly used method in many developing countries.
Miswak has a widespread among religious, rural and developing countries for its spiritual impact since the use of miswak was advised by prophet mohammed (peace be upon him) centuries ago as he said "had I not thought it difficult for my ummah, I would have commanded them to use miswak before every prayer".
Miswak has been recommended by world health organization for oral hygiene because of its availability, beneficial effect and affordability. Previous chemical examinations changed our idea in Miswak which showed us that miswak sticks contain natural ingredients which benefits our oral health. Miswak extracts appear to have different beneficial biological properties like anti-bacterial and anti-fungal effects which will play a high role in oral hygiene measures.
Multiple researches suggested that miswak has anti-cariogenic effects. several studies concluded that Chewing sticks (miswak) has revealed parallel and at times greater mechanical and chemical cleansing of oral tissues as compared to a toothbrush.
The popularity of Miswak in Arab countries has meant that there have been several studies that have confirmed the ability of miswak to provide effective mechanical and chemical cleansing when used as an adjunct to other oral hygiene aids. In a previous study found that the periodontal health of miswak users was better than the periodontal health of manual toothbrush users, also it was concluded that miswak is more effective than tooth brushing for reducing plaque and gingivitis when preceded by professional instruction regarding its correct application.
Another research reported the opposite thing, Punit Patel and S. Shruthi studied the clinical effects of miswak as an adjunct to tooth brushing on gingivitis clearly and they find that the indication of miswak cannot replace the toothbrush, but can be used an adjunct to toothbrush, utilizing the mechanical efficacy of toothbrush and chemical effects of miswak.
However, it was concluded that "The use of S. persica miswak alone or in combination with conventional toothbrushes, when performed judiciously, will result in superior oral health and hygiene." Fluoridated tooth paste and manual tooth brushes have been the standard of clinical preventive dental care for over 50 years. However, the objection to the use of fluorides by some parents has meant that these pastes are not universally accepted.
There is a lot of controversy whether the miswak alone can be used for effective plaque removal and good gingival health or should it be only used as an adjunct to tooth brushing.
In this study we will determine whether the miswak can be used as the chief tool in oral health rather than an adjunct to tooth brushing. We will also determine whether toothpaste using the miswak extract can be as effective as the normal fluoridated toothpaste.
- Conditions
- Dental Plaque
- Being tested
- Fluoride toothpaste, Toothpaste Product, Toothbrush, Miswak Stick
- Keywords
- miswak, siwak, S. persica, chew stick
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride toothpasteDrug
Fluoridated paste containing 1450ppm NaF
Toothpaste ProductDrug
Non Fluoridated toothpaste with extract of miswak ( Dabur, miswak tooth paste)
ToothbrushDevice
Colgate classic clean Soft bristled toothbrushes, 19.05 x 1.27 x 1.91 cm
Miswak StickDevice
A miswak stick of 15 cm length
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants will be trained to perform oral hygiene using the modified bass technique.
The participants will be asked to brush their teeth twice daily using a manual tooth brush and fluoridated toothpaste containing 1450ppm of fluoride Receives: Drug: Fluoride toothpaste; Device: Toothbrush |
| Miswak | Experimental | Participants will be trained to chew and condition a miswak stick Participants will be asked to use the miswak stick twice daily Receives: Device: Miswak Stick |
| Miswak Paste | Experimental | Participants will be trained to perform oral hygiene using the modified bass technique.
The participants will be asked to brush their teeth twice daily using a manual tooth brush a non-fluoridated toothpaste containing miswak extract Receives: Drug: Toothpaste Product; Device: Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Base line Plaque Score
Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque
Measured: Baseline
Plaque Score change at 1 week
Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque
Measured: One week
Plaque Score change at 2 weeks
Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque
Measured: Two weeks
Baseline Bleeding Score
Gingival Index (Loe \& Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation
Measured: Baseline
Bleeding Score change at 1 week
Gingival Index (Loe \& Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation
Measured: One week
Bleeding Score change at 2 weeks
Gingival Index (Loe \& Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation
Measured: Two weeks
Secondary outcomes (1)
Presence of White spot lesions
Visual Initial signs of dental caries
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start30 Sep 2020
- Primary completion10 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Samer Aburaisi, Riyadh Elm University
- Investigators
- Omar Alkadhi, MSc, Study chair, Head of IRB, REUSarah S Aburaisi, MSc, Principal investigator, Assistant Professor, prothetic dental department, REU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561960
- Sponsor's protocol ID
- FRP/2020/264
- Status last verified
- Mar 2021
- First submitted
- 16 Sep 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hawkins BF, Kohout FJ, Lainson PA, Heckert A. Duration of toothbrushing for effective plaque control. Quintessence Int. 1986 Jun;17(6):361-5. No abstract available.
PubMed 3460112Elvin-Lewis M. The therapeutic potential of plants used in dental folk medicine. Odontostomatol Trop. 1982 Sep;5(3):107-17. No abstract available.
PubMed 6962424Patel PV, Shruthi S, Kumar S. Clinical effect of miswak as an adjunct to tooth brushing on gingivitis. J Indian Soc Periodontol. 2012 Jan;16(1):84-8. doi: 10.4103/0972-124X.94611.
PubMed 22628969Al-Otaibi M, Al-Harthy M, Gustafsson A, Johansson A, Claesson R, Angmar-Mansson B. Subgingival plaque microbiota in Saudi Arabians after use of miswak chewing stick and toothbrush. J Clin Periodontol. 2004 Dec;31(12):1048-53. doi: 10.1111/j.1600-051X.2004.00618.x.
PubMed 15560804Halawany HS. A review on miswak (Salvadora persica) and its effect on various aspects of oral health. Saudi Dent J. 2012 Apr;24(2):63-9. doi: 10.1016/j.sdentj.2011.12.004. Epub 2012 Jan 28.
PubMed 23960531Haque MM, Alsareii SA. A review of the therapeutic effects of using miswak (Salvadora Persica) on oral health. Saudi Med J. 2015 May;36(5):530-43. doi: 10.15537/smj.2015.5.10785.
PubMed 25935172Devi, Aruna M.; Hampannavar, Pooja; Radha, G.; Kadanakuppe, Sushi; Nagashree, S. R.; Kumar, Vinod A. (2011) Comparing the Efficacy of Plaque Removal between Salvadora persica (Miswak) and Manual Toothbrush in 12 to 15 Years School Children. World Journal of Dentistry, 2(1), pp. 29-33.
Norton MR, Addy M. Chewing sticks versus toothbrushes in West Africa. A pilot study. Clin Prev Dent. 1989 May-Jun;11(3):11-3.
PubMed 2605858Malik AS, Shaukat MS, Qureshi AA, Abdur R. Comparative effectiveness of chewing stick and toothbrush: a randomized clinical trial. N Am J Med Sci. 2014 Jul;6(7):333-7. doi: 10.4103/1947-2714.136916.
PubMed 25077082World Health Organization. (1997). Oral health surveys: basic methods, 4th ed. World Health Organization
Darout IA, Skaug N, Albandar JM. Subgingival microbiota levels and their associations with periodontal status at the sampled sites in an adult Sudanese population using miswak or toothbrush regularly. Acta Odontol Scand. 2003 Apr;61(2):115-22. doi: 10.1080/00016350310002784.
PubMed 12790510
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Miswak When Compared to Fluoridated Toothpaste for the Maintenance of Oral Hygiene in Young Adults
- ClinicalTrials.gov ID
- NCT04561960
- Acronym / sponsor ID
- FRP/2020/264
- Conditions
- Dental Plaque
- Keywords
- miswak, siwak, S. persica, chew stick
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 24 Sep 2020 (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.
Miswak has been recommended by world health organization for oral hygiene because of its availability, beneficial effect and affordability. The popularity of Miswak in Arab countries has meant that there have been several studies that have confirmed the ability of miswak to provide effective mechanical and chemical cleansing when used as an adjunct to other oral hygiene aids.
Fluoridated tooth paste and manual tooth brushes have been the standard of clinical preventive dental care for over 50 years.However, the objection to the use of fluorides by some parents has meant that these pastes are not universally accepted.
There are several non-fluoridated pastes available in the market that include the extract of miswak. There are few studies that have compared these pastes to fluoridated pastes and to miswak as a stand alone agents.
Miswak has been recommended by world health organization in 1987 for oral hygiene because of its availability, beneficial effect and affordability.
It has been stated that "Several clinical studies have confirmed that the mechanical and chemical cleansing efficiency of miswak chewing sticks are equal and at times greater than that of the toothbrush" this was mentioned and reviewed that it is in fact right but only when used in a regular constant matter with a proper and effective way of plaque removal. This study aims to use a cross over model to study the effectiveness of miswak as a stand alone agent in maintaining oral hygiene in young adults and compare it miswak containing toothpastes and fluoridated toothpastes when used with a manual tooth brush.
Detailed description
Oral hygiene is the key of maintaining human's mouth at a state of equilibrium and free of diseases (e.g. cavities, dental decay, gingivitis, halitosis). Poor oral hygiene can significantly affect the quality of life and has a considerable influence on diet, sleeping, social communication, psychological status, and by being less productive at work.
Therefore, oral hygiene is essential for general health and well-being. Oral hygiene measures include toothbrush which is the most commonly used method for plaque control. However, miswak is a commonly used method in many developing countries.
Miswak has a widespread among religious, rural and developing countries for its spiritual impact since the use of miswak was advised by prophet mohammed (peace be upon him) centuries ago as he said "had I not thought it difficult for my ummah, I would have commanded them to use miswak before every prayer".
Miswak has been recommended by world health organization for oral hygiene because of its availability, beneficial effect and affordability. Previous chemical examinations changed our idea in Miswak which showed us that miswak sticks contain natural ingredients which benefits our oral health. Miswak extracts appear to have different beneficial biological properties like anti-bacterial and anti-fungal effects which will play a high role in oral hygiene measures.
Multiple researches suggested that miswak has anti-cariogenic effects. several studies concluded that Chewing sticks (miswak) has revealed parallel and at times greater mechanical and chemical cleansing of oral tissues as compared to a toothbrush.
The popularity of Miswak in Arab countries has meant that there have been several studies that have confirmed the ability of miswak to provide effective mechanical and chemical cleansing when used as an adjunct to other oral hygiene aids. In a previous study found that the periodontal health of miswak users was better than the periodontal health of manual toothbrush users, also it was concluded that miswak is more effective than tooth brushing for reducing plaque and gingivitis when preceded by professional instruction regarding its correct application.
Another research reported the opposite thing, Punit Patel and S. Shruthi studied the clinical effects of miswak as an adjunct to tooth brushing on gingivitis clearly and they find that the indication of miswak cannot replace the toothbrush, but can be used an adjunct to toothbrush, utilizing the mechanical efficacy of toothbrush and chemical effects of miswak.
However, it was concluded that "The use of S. persica miswak alone or in combination with conventional toothbrushes, when performed judiciously, will result in superior oral health and hygiene." Fluoridated tooth paste and manual tooth brushes have been the standard of clinical preventive dental care for over 50 years. However, the objection to the use of fluorides by some parents has meant that these pastes are not universally accepted.
There is a lot of controversy whether the miswak alone can be used for effective plaque removal and good gingival health or should it be only used as an adjunct to tooth brushing.
In this study we will determine whether the miswak can be used as the chief tool in oral health rather than an adjunct to tooth brushing. We will also determine whether toothpaste using the miswak extract can be as effective as the normal fluoridated toothpaste.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Fluoride toothpaste, Device: ToothbrushParticipants will be trained to perform oral hygiene using the modified bass technique. The participants will be asked to brush their teeth twice daily using a manual tooth brush and fluoridated toothpaste containing 1450ppm of fluoride |
| Miswak | Experimental | Device: Miswak StickParticipants will be trained to chew and condition a miswak stick Participants will be asked to use the miswak stick twice daily |
| Miswak Paste | Experimental | Drug: Toothpaste Product, Device: ToothbrushParticipants will be trained to perform oral hygiene using the modified bass technique. The participants will be asked to brush their teeth twice daily using a manual tooth brush a non-fluoridated toothpaste containing miswak extract |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults
- Able to perform their own oral hygiene
- Dental students
Key exclusion criteria (5 listed)
- Active Dental Caries
- Uncontrolled chronic medical conditions
- History of drug and/or treatment that reduces salivary flow
- Currently undergoing orthodontic treatment
- Missing index teeth #16, #12, #24, #36, #32, #44
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 |
|---|---|---|
| Fluoride toothpasteFluoridated paste containing 1450ppm NaF | Drug | Control |
| Toothpaste ProductNon Fluoridated toothpaste with extract of miswak ( Dabur, miswak tooth paste) | Drug | Miswak Paste |
| ToothbrushColgate classic clean Soft bristled toothbrushes, 19.05 x 1.27 x 1.91 cm | Device | Control, Miswak Paste |
| Miswak StickA miswak stick of 15 cm length | Device | Miswak |
Primary outcome
Base line Plaque Score
Time frame: Baseline
Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque
Plaque Score change at 1 week
Time frame: One week
Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque
Plaque Score change at 2 weeks
Time frame: Two weeks
Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque
Baseline Bleeding Score
Time frame: Baseline
Gingival Index (Loe \& Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation
Bleeding Score change at 1 week
Time frame: One week
Gingival Index (Loe \& Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation
Bleeding Score change at 2 weeks
Time frame: Two weeks
Gingival Index (Loe \& Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation
1 secondary outcome
Presence of White spot lesions
Time frame: Two weeks
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 10 Mar 2021.
- Results publication: PubMed 3460112Hawkins BF, Kohout FJ, Lainson PA, Heckert A. Duration of toothbrushing for effective plaque control. Quintessence Int. 1986 Jun;17(6):361-5. No abstract available.
- Results publication: PubMed 6962424Elvin-Lewis M. The therapeutic potential of plants used in dental folk medicine. Odontostomatol Trop. 1982 Sep;5(3):107-17. No abstract available.
- Results publication: PubMed 22628969Patel PV, Shruthi S, Kumar S. Clinical effect of miswak as an adjunct to tooth brushing on gingivitis. J Indian Soc Periodontol. 2012 Jan;16(1):84-8. doi: 10.4103/0972-124X.94611.
- Results publication: PubMed 15560804Al-Otaibi M, Al-Harthy M, Gustafsson A, Johansson A, Claesson R, Angmar-Mansson B. Subgingival plaque microbiota in Saudi Arabians after use of miswak chewing stick and toothbrush. J Clin Periodontol. 2004 Dec;31(12):1048-53. doi: 10.1111/j.1600-051X.2004.00618.x.
- Results publication: PubMed 23960531Halawany HS. A review on miswak (Salvadora persica) and its effect on various aspects of oral health. Saudi Dent J. 2012 Apr;24(2):63-9. doi: 10.1016/j.sdentj.2011.12.004. Epub 2012 Jan 28.
- Results publication: PubMed 25935172Haque MM, Alsareii SA. A review of the therapeutic effects of using miswak (Salvadora Persica) on oral health. Saudi Med J. 2015 May;36(5):530-43. doi: 10.15537/smj.2015.5.10785.
- Results publicationDevi, Aruna M.; Hampannavar, Pooja; Radha, G.; Kadanakuppe, Sushi; Nagashree, S. R.; Kumar, Vinod A. (2011) Comparing the Efficacy of Plaque Removal between Salvadora persica (Miswak) and Manual Toothbrush in 12 to 15 Years School Children. World Journal of Dentistry, 2(1), pp. 29-33.
- Results publication: PubMed 2605858Norton MR, Addy M. Chewing sticks versus toothbrushes in West Africa. A pilot study. Clin Prev Dent. 1989 May-Jun;11(3):11-3.
- Results publication: PubMed 25077082Malik AS, Shaukat MS, Qureshi AA, Abdur R. Comparative effectiveness of chewing stick and toothbrush: a randomized clinical trial. N Am J Med Sci. 2014 Jul;6(7):333-7. doi: 10.4103/1947-2714.136916.
- Results publicationWorld Health Organization. (1997). Oral health surveys: basic methods, 4th ed. World Health Organization
- Results publication: PubMed 12790510Darout IA, Skaug N, Albandar JM. Subgingival microbiota levels and their associations with periodontal status at the sampled sites in an adult Sudanese population using miswak or toothbrush regularly. Acta Odontol Scand. 2003 Apr;61(2):115-22. doi: 10.1080/00016350310002784.
- Individual participant dataSharing planned: No
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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.
Omar Alkadhi, MSc study chair
Head of IRB, REU
Sarah S Aburaisi, MSc principal investigator
Assistant Professor, prothetic dental department, REU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoride toothpaste, Toothpaste Product and Toothbrush in people with Dental Plaque, run by Riyadh Elm University at 1 site in Saudi Arabia.
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 3 inclusion and 5 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Base line Plaque Score (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04561960, which also lists 11 linked publications.
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 10 Mar 2021.