Plaque Induced GingivitisNCT05803590
Compare the Effect of Green Tea Mouthwash vs Chlorohexidine Mouthwash in Children With Plaque-induced Gingivitis
A study testing Green tea mouthwash and Chlorhexidine mouthwash in people with Plaque Induced Gingivitis, run by Cairo University.
Trial summary
This study aims to assess and compare the effect of green tea mouthwash compared to chlorohexidine mouthwash in reducing gingivitis and plaque scores (in terms of plaque index and gingival index) in children with plaque-induced gingivitis. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Induced Gingivitis
- What is being tested?
- Green tea mouthwash and Chlorhexidine mouthwash
- 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
- 1 May 2023to 1 Aug 2023
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 10-14 years.
- Children with a gingival index score of ≥ 1 and a plaque index score of ≥ 1.
- Children in good medical health and free from major oral hard or soft tissue lesions. [Medically fit children (ASA I, II)].
- Children classified as cooperative or potentially cooperative according to Wright's classification of child behavior.
- Children mentally capable of communication.
Who cannot join
- Parental refusal for participation.
- Children under antibiotics treatment during the last six weeks prior to the study.
- Children wearing fixed or removable orthodontic devices.
- Patients who underwent oral prophylaxis in the last six months.
Trial locations and contacts
No sites are listed yet.
Marwa A. Aly, PhD contact
About this study
Official title: Comparative Effect of Green Tea Versus Chlorhexidine Mouthwash on Plaque Induced Gingivitis In a Group of Egyptian Children: Randomized Clinical Trial
This study aims to assess and compare the effect of green tea mouthwash compared to chlorohexidine mouthwash in reducing gingivitis and plaque scores (in terms of plaque index and gingival index) in children with plaque-induced gingivitis.
Read the detailed description
This study aims to assess and compare the effect of green tea mouthwash compared to chlorohexidine mouthwash in reducing gingivitis and plaque scores (in terms of plaque index and gingival index) in children with plaque-induced gingivitis.
This study will be conducted in the outpatient clinics of the Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University - Egypt.
Patients attending the outpatient clinic in Pediatric Dentistry and Dental Public health Department - Faculty of Dentistry - Cairo University - Egypt will be screened until the target population is achieved.
- Conditions
- Plaque Induced Gingivitis
- Being tested
- Green tea mouthwash, Chlorhexidine mouthwash
- Keywords
- green tea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green tea mouthwashDrug
effictive against caries and periodontal diseases
Chlorhexidine mouthwashDrug
the gold standard against which other anti-plaque and gingivitis agents are measured
| Study group | Role | What they receive |
|---|---|---|
| Green Tea Mouthwash ( intervention ) | Active comparator | Green tea (GT), obtained from the extracts of a small plant, Camelia sinesis, is common worldwide. It is rich in flavonoids such as catechins and various other polyphenols, contributing to its antioxidant and anti-inflammatory properties. Green tea consumption is also associated with lower incidences of diabetes, cardiovascular disease, and obesity. Moreover, its antibacterial property aids in the reduction of bacterial colonization and thereby prevents oral diseases such as gingivitis, periodontal diseases, dental caries, and malodor .
When used as a mouthwash, green tea preparations can obliterate bad breath by suppressing anaerobic bacteria and eradicating the production of volatile sulfur compounds. There is a lack of critically appraised summaries on the efficacy of green tea mouthwash for promoting dental hygiene . Receives: Drug: Green tea mouthwash; Drug: Chlorhexidine mouthwash |
| Chlorhexidine Mouthwash ( control ) | Experimental | Chlorhexidine was developed in 1950 and is the most used anti-plaque agent. However, the long-term usage of chlorhexidine (CHX) is limited by altered taste perception and tooth staining with prolonged usage. Though CHX has been the gold standard mouthwash in controlling plaque formation, its undesirable side effects, such as the enhanced ability of calculus formation, bitter taste, and interference with taste, have inspired a search for alternatives Receives: Drug: Green tea mouthwash; Drug: Chlorhexidine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingivitis will be recorded by the Gingival index
Gingival Index (GI): (Loe and Sillness Index) records qualitative changes in the gingiva. It scores the marginal and interproximal tissues separately based on 0 to 3. The criteria are:
0= Normal gingiva.
1= Mild inflammation - a slight change in color and slight edema but no bleeding on probing. 2= Moderate inflammation - redness, edema, and glazing, bleeding on probing.
3= Severe inflammation - marked redness and edema, ulceration with the tendency to spontaneous bleeding.
The bleeding is assessed by gently probing along the wall of the soft tissue of the gingival sulcus. The scores of the four areas of the tooth can be summed and divided by four to give the GI for the tooth. The GI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The Gingival Index may be scored for all surfaces or selected teeth or for selected areas of all teeth.
Measured: one hour
Secondary outcomes (1)
Presence of dental plaque will be recorded by the Plaque index
Plaque Index (PI): (Sillness and Loe Index) is an index for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin (the gingival one-third of the teeth). It can be used on all teeth or selected teeth. It is used on all four surfaces (M, B, D, L). The criteria are:
0= No plaque.
- A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can not be seen with the naked eye. But only by using disclosing solution or using a probe.
- Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.
- Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abd Elnaser Yehia Fatoh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803590
- Sponsor's protocol ID
- GT Mouthwash In Children
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 7 Apr 2023
- 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 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Green Tea Versus Chlorhexidine Mouthwash on Plaque Induced Gingivitis In a Group of Egyptian Children: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05803590
- Acronym / sponsor ID
- GT Mouthwash In Children
- Conditions
- Plaque Induced Gingivitis
- Keywords
- green tea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 7 Apr 2023 (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 study aims to assess and compare the effect of green tea mouthwash compared to chlorohexidine mouthwash in reducing gingivitis and plaque scores (in terms of plaque index and gingival index) in children with plaque-induced gingivitis.
Detailed description
This study aims to assess and compare the effect of green tea mouthwash compared to chlorohexidine mouthwash in reducing gingivitis and plaque scores (in terms of plaque index and gingival index) in children with plaque-induced gingivitis.
This study will be conducted in the outpatient clinics of the Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University - Egypt.
Patients attending the outpatient clinic in Pediatric Dentistry and Dental Public health Department - Faculty of Dentistry - Cairo University - Egypt will be screened until the target population is achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green Tea Mouthwash ( intervention ) | Active comparator | Drug: Green tea mouthwash, Drug: Chlorhexidine mouthwashGreen tea (GT), obtained from the extracts of a small plant, Camelia sinesis, is common worldwide. It is rich in flavonoids such as catechins and various other polyphenols, contributing to its antioxidant and anti-inflammatory properties. Green tea consumption is also associated with lower incidences of diabetes, cardiovascular disease, and obesity. Moreover, its antibacterial property aids in the reduction of bacterial colonization and thereby prevents oral diseases such as gingivitis, periodontal diseases, dental caries, and malodor . When used as a mouthwash, green tea preparations can obliterate bad breath by suppressing anaerobic bacteria and eradicating the production of volatile sulfur compounds. There is a lack of critically appraised summaries on the efficacy of green tea mouthwash for promoting dental hygiene . |
| Chlorhexidine Mouthwash ( control ) | Experimental | Drug: Green tea mouthwash, Drug: Chlorhexidine mouthwashChlorhexidine was developed in 1950 and is the most used anti-plaque agent. However, the long-term usage of chlorhexidine (CHX) is limited by altered taste perception and tooth staining with prolonged usage. Though CHX has been the gold standard mouthwash in controlling plaque formation, its undesirable side effects, such as the enhanced ability of calculus formation, bitter taste, and interference with taste, have inspired a search for alternatives |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 10-14 years.
- Children with a gingival index score of ≥ 1 and a plaque index score of ≥ 1.
- Children in good medical health and free from major oral hard or soft tissue lesions. [Medically fit children (ASA I, II)].
- Children classified as cooperative or potentially cooperative according to Wright's classification of child behavior.
- Children mentally capable of communication.
Key exclusion criteria (4 listed)
- Parental refusal for participation.
- Children under antibiotics treatment during the last six weeks prior to the study.
- Children wearing fixed or removable orthodontic devices.
- Patients who underwent oral prophylaxis in the last six months.
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 mouthwasheffictive against caries and periodontal diseases | Drug | Chlorhexidine Mouthwash ( control ), Green Tea Mouthwash ( intervention ) |
| Chlorhexidine mouthwashthe gold standard against which other anti-plaque and gingivitis agents are measured | Drug | Chlorhexidine Mouthwash ( control ), Green Tea Mouthwash ( intervention ) |
Primary outcome
Gingivitis will be recorded by the Gingival index
Time frame: one hour
Gingival Index (GI): (Loe and Sillness Index) records qualitative changes in the gingiva. It scores the marginal and interproximal tissues separately based on 0 to 3. The criteria are: 0= Normal gingiva. 1= Mild inflammation - a slight change in color and slight edema but no bleeding on probing. 2= Moderate inflammation - redness, edema, and glazing, bleeding on probing. 3= Severe inflammation - marked redness and edema, ulceration with the tendency to spontaneous bleeding. The bleeding is assessed by gently probing along the wall of the soft tissue of the gingival sulcus. The scores of the four areas of the tooth can be summed and divided by four to give the GI for the tooth. The GI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The Gingival Index may be scored for all surfaces or selected teeth or for selected areas of all teeth.
1 secondary outcome
Presence of dental plaque will be recorded by the Plaque index
Time frame: one hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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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.
Marwa A. Aly, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Green tea mouthwash and Chlorhexidine mouthwash in people with Plaque Induced Gingivitis, run by Cairo 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya A. Yehia, master (01062810438 ext. +2, aya.abdelnaser@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingivitis will be recorded by the Gingival index (time frame: one hour). 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 7 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.