GingivitisEarly Phase 1MiswakChlorxNCT04607785
Miswak Efficacy Compared With Chlorhexidine
A Early Phase 1 study testing Miswak mouthwash group and Chlorhexidine gluconate mouthwash in people with Gingivitis, run by Al-Iraqia University at 1 site in Iraq.
Trial summary
Gingivitis is a form of gum disease and is elicited by the accumulation of plaque on the tooth and the soft-tissue adjoining the tooth. Mouthwashes containing chemical or herbal substances are adjunctive tools in improving oral hygiene. Miswak mouthwash is a herbal mouthwash. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- Miswak mouthwash group and Chlorhexidine gluconate mouthwash
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 15 Jan 2020to 15 Mar 2020
- Phase
- Early Phase 1
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults with existence at least 20 natural teeth in the mouth
- Existence of lateral maxillary teeth
- Existence of central teeth
- Existence of mandibular teeth
Who cannot join
- Patients have no history of drug use
- Patients have no any disease relevant occurrence
- Pocket depth<3 mm
- Smokers
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparative Evaluation of Efficacy of 40% Miswak Mouthwash With 0.12% Chlorhexidine Mouthwash Among Gingivitis: A Blind Randomized Controlled Trial
Gingivitis is a form of gum disease and is elicited by the accumulation of plaque on the tooth and the soft-tissue adjoining the tooth. Mouthwashes containing chemical or herbal substances are adjunctive tools in improving oral hygiene. Miswak mouthwash is a herbal mouthwash. Chlorhexidine mouthwash is the most efficient antimicrobial and antiplaque agent. The aim of the study is to assess the effectiveness of the miswak mouthwash with 0.12% chlorhexidine. This study was a blind randomized clinical trial.
Materials and Methods: A total of 60 patients aged (20-55) years old who attended the Periodontics Clinics at College of Dentistry, Al-Iraqia University were allocated for use the mouthwash either miswak mouthwash or 0.12% chlorhexidine gluconate Kin Gingival® (Laboratorios KIN, Spain) twice daily (once in the morning and one before bedtime) for seven days. Gingival, bleeding, and plaque indices were recorded at baseline and after 7 days of treatment.
Read the detailed description
Gingivitis is the mildest form of gum disease and is elicited by the accumulation of plaque on the tooth and the soft-tissue adjoining the tooth. Accumulation of dental biofilm has been established as the initial cause of this disease. It is determined by redness of the gum margins, edema, bleeding upon brushing, and loss of periodontal attachment loss. Gingivitis exists in both acute and chronic forms. Acute gingivitis is identified as trauma, micro-organisms, and specific infections while chronic inflammation is related to bacterial biofilm which covers the gum and adjoining the teeth. Elimination and control of plaque are very important in the maintenance of periodontal health. Chlorhexidine mouthwash has is a tremendous effect when it is used as a mouthwash for a long time; therefore, the Food and Drug Administration (FDA) recommends limiting the use of chlorhexidine mouthwash up to 6 months to minimize or limit its side effects. Additionally, the World Health Organization (WHO) encouraged to consider the possible use of herb extracts and natural plants mouthwashes instead of chemical mouthwash just as miswak mouthwash. Miswak mouthwash is a herbal mouthwash that is available locally and culturally accepted. It is prepared from a plant called Salvadora persica which comes from a tree (Arak) that grows in Africa and west India.
- Conditions
- Gingivitis
- Being tested
- Miswak mouthwash group, Chlorhexidine gluconate mouthwash
- Keywords
- Miswak, chlorhexidine, mouthwash, gingivitis, oral health
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miswak mouthwash groupDrug
Twice daily for seven days for two months
Chlorhexidine gluconate mouthwashDevice
Also called chlorhexidine gluconate Kin Gingival®
Twice daily for seven days for two months
| Study group | Role | What they receive |
|---|---|---|
| Miswak mouthwash group | Active comparator | Miswak sticks were bought from local markets, Baghdad, Iraq, washed with cold water and dried then crushed into powder. Later,7 grams of the miswak powder weighted and added to 350 ml of distilled water (D.W.) in a conical flask for 24 hours. Finally, the solution then filtered and stored in tightly closed bottles in a cool place.9 Receives: Drug: Miswak mouthwash group; Device: Chlorhexidine gluconate mouthwash |
| Chlorhexidine mouthwash group | Other | 0.12% chlorhexidine gluconate mouthwash for seven days Receives: Drug: Miswak mouthwash group; Device: Chlorhexidine gluconate mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation of gingiva
Change in Gingival index
Measured: 2 months
Bleeding from gingiva
Change in index
Measured: 2 months
Plaque in the gingiva
Change in index
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start15 Jan 2020
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Iraqia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumayah Al-Mahmood, Al-Iraqia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607785
- Sponsor's protocol ID
- 2020DEN
- Acronym
- MiswakChlorx
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: No need
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Evaluation of Efficacy of 40% Miswak Mouthwash With 0.12% Chlorhexidine Mouthwash Among Gingivitis: A Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04607785
- Acronym / sponsor ID
- MiswakChlorx / 2020DEN
- Conditions
- Gingivitis
- Keywords
- Miswak, chlorhexidine, mouthwash, gingivitis, oral health
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Iraqia UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 29 Oct 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.
Gingivitis is a form of gum disease and is elicited by the accumulation of plaque on the tooth and the soft-tissue adjoining the tooth. Mouthwashes containing chemical or herbal substances are adjunctive tools in improving oral hygiene. Miswak mouthwash is a herbal mouthwash. Chlorhexidine mouthwash is the most efficient antimicrobial and antiplaque agent. The aim of the study is to assess the effectiveness of the miswak mouthwash with 0.12% chlorhexidine. This study was a blind randomized clinical trial.
Materials and Methods: A total of 60 patients aged (20-55) years old who attended the Periodontics Clinics at College of Dentistry, Al-Iraqia University were allocated for use the mouthwash either miswak mouthwash or 0.12% chlorhexidine gluconate Kin Gingival® (Laboratorios KIN, Spain) twice daily (once in the morning and one before bedtime) for seven days. Gingival, bleeding, and plaque indices were recorded at baseline and after 7 days of treatment.
Detailed description
Gingivitis is the mildest form of gum disease and is elicited by the accumulation of plaque on the tooth and the soft-tissue adjoining the tooth. Accumulation of dental biofilm has been established as the initial cause of this disease. It is determined by redness of the gum margins, edema, bleeding upon brushing, and loss of periodontal attachment loss. Gingivitis exists in both acute and chronic forms. Acute gingivitis is identified as trauma, micro-organisms, and specific infections while chronic inflammation is related to bacterial biofilm which covers the gum and adjoining the teeth. Elimination and control of plaque are very important in the maintenance of periodontal health. Chlorhexidine mouthwash has is a tremendous effect when it is used as a mouthwash for a long time; therefore, the Food and Drug Administration (FDA) recommends limiting the use of chlorhexidine mouthwash up to 6 months to minimize or limit its side effects. Additionally, the World Health Organization (WHO) encouraged to consider the possible use of herb extracts and natural plants mouthwashes instead of chemical mouthwash just as miswak mouthwash. Miswak mouthwash is a herbal mouthwash that is available locally and culturally accepted. It is prepared from a plant called Salvadora persica which comes from a tree (Arak) that grows in Africa and west India.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miswak mouthwash group | Active comparator | Drug: Miswak mouthwash group, Device: Chlorhexidine gluconate mouthwashMiswak sticks were bought from local markets, Baghdad, Iraq, washed with cold water and dried then crushed into powder. Later,7 grams of the miswak powder weighted and added to 350 ml of distilled water (D.W.) in a conical flask for 24 hours. Finally, the solution then filtered and stored in tightly closed bottles in a cool place.9 |
| Chlorhexidine mouthwash group | Other | Drug: Miswak mouthwash group, Device: Chlorhexidine gluconate mouthwash0.12% chlorhexidine gluconate mouthwash for seven days |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults with existence at least 20 natural teeth in the mouth
- Existence of lateral maxillary teeth
- Existence of central teeth
- Existence of mandibular teeth
Key exclusion criteria (5 listed)
- Patients have no history of drug use
- Patients have no any disease relevant occurrence
- Pocket depth<3 mm
- Smokers
- Pregnancy
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 mouthwash groupTwice daily for seven days for two months | Drug | Chlorhexidine mouthwash group, Miswak mouthwash group |
| Chlorhexidine gluconate mouthwashAlso: chlorhexidine gluconate Kin Gingival®Twice daily for seven days for two months | Device | Chlorhexidine mouthwash group, Miswak mouthwash group |
Primary outcome
Inflammation of gingiva
Time frame: 2 months
Change in Gingival index
Bleeding from gingiva
Time frame: 2 months
Change in index
Plaque in the gingiva
Time frame: 2 months
Change in 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 Nov 2020.
- Individual participant dataSharing planned: No. No need
Related trials for Gingivitis
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The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Miswak mouthwash group and Chlorhexidine gluconate mouthwash in people with Gingivitis, run by Al-Iraqia University at 1 site in Iraq.
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 4 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 3 Nov 2020. 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 Iraq. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Inflammation of gingiva (time frame: 2 months). The study lists 3 primary outcomes in all. 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 Nov 2020.