Plaque Induced Gingival DiseasemouthwashNCT06711263
Role of Herbal Based Mouthwashes in Plaque Control
A study testing Mouthwash Product in people with Plaque Induced Gingival Disease, run by Ajman University.
Trial summary
Herbal medicine has been used for thousands of years. Traditional herbal medicine is used by an estimated 80% of the world's population for primary health care. Herbal treatments have gained popularity as a dietary supplement for illness prevention and as an alternative/complementary therapy in recent years. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plaque Induced Gingival Disease
- What is being tested?
- Mouthwash Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are medically fit
- Patients with gingival inflammation not progressed into periodontitis (AAP classification
- Patients between the age of 18-60 years
Who cannot join
- Patients who are medically compromised
- Patient who have undergone a periodontal therapy for the past 3 months
- Patients who are healthy but have been using herbal mouthwashes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of Herbal Based Mouthwashes in Plaque Control. a Randomized Clinical Control Trial
Herbal medicine has been used for thousands of years. Traditional herbal medicine is used by an estimated 80% of the world's population for primary health care. Herbal treatments have gained popularity as a dietary supplement for illness prevention and as an alternative/complementary therapy in recent years. Herbal remedies come in a wide variety of forms and can be found on the market all over the world.
Read the detailed description
Herbal mouthwashes have been increasingly popular over time. Ethnomedicines are the term used to describe them. Various substances have been tested, with phytopharmacological analyses yielding contradictory results. Many previous studies had tested the antiplaque efficiency of one herbal mouthwash with contradicting results, other studies have tested the Antiplaque efficiency of chlorhexidine, tea tree oil and Miswak, some studies had given positive outcomes and benefits of Miswak on the gingiva and others when comparing between the efficacy of Miswak over chlorhexidine mouth wash in dental practice provided results favouring both these mouthwashes.
In our proposed study we will compare the antiplaque efficiency of three herbal kinds of mouthwash, Miswak, tea tree oil and Resveratrol mouthwash. Plaque and gingival bleeding scores will be taken before the study from 6 different teeth and retaken after 2 weeks and four weeks respectively the use of the mouthwash. This study is single-blinded. Antiplaque and gingival bleeding scores from the three mouthwashes will be recorded over a period of a month and statistical analysis will be performed
- Conditions
- Plaque Induced Gingival Disease
- Being tested
- Mouthwash Product
- Keywords
- plaque, gingival bleeding, resveratrol, miswak, tea tree oil, chlorhexidine
- Medical subject headings
- Plaque, Amyloid, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouthwash ProductOther
Also called chlorhexidine, resverotriol, miswak, tea tree oil
- In the Initial Visit-Baseline, and subsequent visits, participants will be called in the morning. Morning hours will be chosen for examination, as it will reduce the risk of bias and also help in quantifying results. plaque and gingival scores will be recorded and the First herbal mouthwashes will be given, participants will also be provided new tooth-brushes (Oral B-soft).
- They will be asked to follow their routine oral hygiene habits. They will be asked to come back after 2 weeks for plaque and gingival bleeding scores recording for the second visit and again after 2weeks post the second visit for the third and final visit to record their plaque and gingival bleeding scores.
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine | Experimental | Mouthwash will be used for these participants Receives: Other: Mouthwash Product |
| Tea tree oil | Active comparator | Participants will use the mouthwash and plaque and gingival bleeding indice will be recorded at baseline, after 2 weeks and after 4 weeks Receives: Other: Mouthwash Product |
| Reseverotriol | Active comparator | Participants will use the mouthwash and plaque and gingival bleeding indice will be recorded at baseline, after 2 weeks and after 4 weeks Receives: Other: Mouthwash Product |
| Miswak | Active comparator | Participants will use the mouthwash and plaque and gingival bleeding indice will be recorded at baseline, after 2 weeks and after 4 weeks Receives: Other: Mouthwash Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
plaque score
To assess the plaque score
Measured: From Baseline-pre-intervention to the end of treatment at 4 weeks
Secondary outcomes (1)
gingival bleeding score
To assess gingival bledding score
Measured: from pre-intervention to the end of the treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion20 Feb 2025 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Induced Gingival DiseaseStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the Initial Visit-Baseline, and subsequent visits, participants will be called in the morning. Morning hours will be chosen for examination, as it will reduce the risk of bias and also help in quantifying results. plaque and gingival scores will be recorded and the First herbal mouthwashes will be given, participants will also be provided new tooth-brushes (Oral B-soft).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sudhir rama varma, Ajman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711263
- Sponsor's protocol ID
- Ajman Herbal mouthwash 2425
- Acronym
- mouthwash
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Herbal Based Mouthwashes in Plaque Control. a Randomized Clinical Control Trial
- ClinicalTrials.gov ID
- NCT06711263
- Acronym / sponsor ID
- mouthwash / Ajman Herbal mouthwash 2425
- Conditions
- Plaque Induced Gingival Disease
- Keywords
- plaque, gingival bleeding, resveratrol, miswak, tea tree oil, chlorhexidine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ajman UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 2 Dec 2024 (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.
Herbal medicine has been used for thousands of years. Traditional herbal medicine is used by an estimated 80% of the world's population for primary health care. Herbal treatments have gained popularity as a dietary supplement for illness prevention and as an alternative/complementary therapy in recent years. Herbal remedies come in a wide variety of forms and can be found on the market all over the world.
Detailed description
Herbal mouthwashes have been increasingly popular over time. Ethnomedicines are the term used to describe them. Various substances have been tested, with phytopharmacological analyses yielding contradictory results. Many previous studies had tested the antiplaque efficiency of one herbal mouthwash with contradicting results, other studies have tested the Antiplaque efficiency of chlorhexidine, tea tree oil and Miswak, some studies had given positive outcomes and benefits of Miswak on the gingiva and others when comparing between the efficacy of Miswak over chlorhexidine mouth wash in dental practice provided results favouring both these mouthwashes.
In our proposed study we will compare the antiplaque efficiency of three herbal kinds of mouthwash, Miswak, tea tree oil and Resveratrol mouthwash. Plaque and gingival bleeding scores will be taken before the study from 6 different teeth and retaken after 2 weeks and four weeks respectively the use of the mouthwash. This study is single-blinded. Antiplaque and gingival bleeding scores from the three mouthwashes will be recorded over a period of a month and statistical analysis will be performed
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- In the Initial Visit-Baseline, and subsequent visits, participants will be called in the morning. Morning hours will be chosen for examination, as it will reduce the risk of bias and also help in quantifying results. plaque and gingival scores will be recorded and the First herbal mouthwashes will be given, participants will also be provided new tooth-brushes (Oral B-soft).
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine | Experimental | Other: Mouthwash ProductMouthwash will be used for these participants |
| Tea tree oil | Active comparator | Other: Mouthwash ProductParticipants will use the mouthwash and plaque and gingival bleeding indice will be recorded at baseline, after 2 weeks and after 4 weeks |
| Reseverotriol | Active comparator | Other: Mouthwash ProductParticipants will use the mouthwash and plaque and gingival bleeding indice will be recorded at baseline, after 2 weeks and after 4 weeks |
| Miswak | Active comparator | Other: Mouthwash ProductParticipants will use the mouthwash and plaque and gingival bleeding indice will be recorded at baseline, after 2 weeks and after 4 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who are medically fit
- Patients with gingival inflammation not progressed into periodontitis (AAP classification
- Patients between the age of 18-60 years
Key exclusion criteria (3 listed)
- Patients who are medically compromised
- Patient who have undergone a periodontal therapy for the past 3 months
- Patients who are healthy but have been using herbal mouthwashes
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 |
|---|---|---|
| Mouthwash ProductAlso: chlorhexidine, resverotriol, miswak, tea tree oil* In the Initial Visit-Baseline, and subsequent visits, participants will be called in the morning. Morning hours will be chosen for examination, as it will reduce the risk of bias and also help in quantifying results. plaque and gingival scores will be recorded and the First herbal mouthwashes will be given, participants will also be provided new tooth-brushes (Oral B-soft). * They will be asked to follow their routine oral hygiene habits. They will be asked to come back after 2 weeks for plaque and gingival bleeding scores recording for the second visit and again after 2weeks post the second visit for the third and final visit to record their plaque and gingival bleeding scores. | Other | Miswak, Reseverotriol, Tea tree oil, chlorhexidine |
Primary outcome
plaque score
Time frame: From Baseline-pre-intervention to the end of treatment at 4 weeks
To assess the plaque score
1 secondary outcome
gingival bleeding score
Time frame: from pre-intervention to the end of the treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthwash Product in people with Plaque Induced Gingival Disease, run by Ajman University.
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 3 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: opening soon, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact sudhir Rama Varma, MDS (971506595075, sudhir2002@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plaque score (time frame: From Baseline-pre-intervention to the end of treatment at 4 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 2 Dec 2024.