Plaque Induced GingivitisPhase 3NCT04484792
Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis
A Phase 3 study testing green tea mouthwash in people with Plaque Induced Gingivitis, run by Taibah University at 1 site in Saudi Arabia.
Trial summary
This investigation will study the effect of green tea mouthwash as an adjunctive therapy to mechanical treatment on gingival health, and whether it has any side effects. This study also aims at increasing the awareness among health professionals and the community regarding the benefits of natural herbal products such… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Plaque Induced Gingivitis
- What is being tested?
- green tea mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 27 Nov 2018to 20 Apr 2020
- Phase
- Phase 3
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients attending the clinics at the Taibah University Dental College and Hospital (TUDCH)
- Age from 18 - 35 years
- Generalized plaque-induced gingivitis (GBI > 85%)
Who cannot join
- Patients with any systemic diseases
- Patients under regular medication (e.g. Contraceptives, Hormone- Replacement Therapy)
- Pregnant or breast-feeding patients
- Smokers
- Periodontitis patients
- Patients who received any form of periodontal therapy within the last 6 months
- Patients who were under antibiotic therapy the past month
- Patients using regular mouthwash or other chemical plaque control agents (e.g. Miswak) except for regular toothpaste (Note: toothpastes with specific anti-inflammatory properties are excluded)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis: A Randomized Controlled Clinical Trial
This investigation will study the effect of green tea mouthwash as an adjunctive therapy to mechanical treatment on gingival health, and whether it has any side effects. This study also aims at increasing the awareness among health professionals and the community regarding the benefits of natural herbal products such as green tea on oral health, opposed to common chemical products. This may provide an efficient alternative for people who are sensitive to certain chemical products or who have limited sources of income and cannot afford expensive treatment of dental problems.
- Conditions
- Plaque Induced Gingivitis
- Being tested
- green tea mouthwash, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green tea mouthwashOther
green tea bags in 100 ml warm water for 5 min
green tea mouthwashOther
, in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.
placeboOther
Plain water
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Other: green tea mouthwash |
| Group B | Experimental | Not described Receives: Other: green tea mouthwash |
| Group C | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
plaque control record
Measured: over 27 days
gingival bleeding index
Measured: over 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start27 Nov 2018
- Primary completion27 Mar 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Induced 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taibah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alhanouf M. AlRehaili, Taibah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484792
- Sponsor's protocol ID
- TUCDREC/20181112/AlRehaili
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04484792
- Acronym / sponsor ID
- TUCDREC/20181112/AlRehaili
- Conditions
- Plaque Induced Gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Taibah UniversityUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 24 Jul 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.
This investigation will study the effect of green tea mouthwash as an adjunctive therapy to mechanical treatment on gingival health, and whether it has any side effects. This study also aims at increasing the awareness among health professionals and the community regarding the benefits of natural herbal products such as green tea on oral health, opposed to common chemical products. This may provide an efficient alternative for people who are sensitive to certain chemical products or who have limited sources of income and cannot afford expensive treatment of dental problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: green tea mouthwash |
| Group B | Experimental | Other: green tea mouthwash |
| Group C | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients attending the clinics at the Taibah University Dental College and Hospital (TUDCH)
- Age from 18 - 35 years
- Generalized plaque-induced gingivitis (GBI > 85%)
Key exclusion criteria (8 listed)
- Patients with any systemic diseases
- Patients under regular medication (e.g. Contraceptives, Hormone- Replacement Therapy)
- Pregnant or breast-feeding patients
- Smokers
- Periodontitis patients
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 |
|---|---|---|
| green tea mouthwashgreen tea bags in 100 ml warm water for 5 min | Other | Group A |
| green tea mouthwash, in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition. | Other | Group B |
| placeboPlain water | Other | Group C |
Primary outcome
plaque control record
Time frame: over 27 days
gingival bleeding index
Time frame: over 27 days
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 24 Jul 2020.
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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 Phase 3 study testing green tea mouthwash in people with Plaque Induced Gingivitis, run by Taibah 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 8 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 24 Jul 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 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
plaque control record (time frame: over 27 days). The study lists 2 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 24 Jul 2020; AzTrials last refreshed its copy on 31 Oct 2026.