Gingival DiseasesNCT06013735
Effects of Three Different Mouth Rinses on Dental Plaque in Children
A study testing sodium fluoride solution, guava leaves aqueous extract and pomegranate peel aqueous extrac in people with Gingival Diseases, run by Suez Canal University at 1 site in Egypt.
Trial summary
Dental plaque is a major problem in the field of oral and dental health and its prevention is more important to avoid dental caries and gingival diseases. Mouth washes are very useful in the reduction of microbial plaque and gingival inflammation. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Gingival Diseases
- What is being tested?
- sodium fluoride solution, guava leaves aqueous extract and pomegranate peel aqueous extrac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Feb 2020to 22 Jun 2021
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children are apparently healthy.
- Their age's ranges from 6-12 years {mixed dentition}, First permanent molars were fully erupted.
- Children are not taking antibiotics, steroids and inflammatory therapy for two weeks before study or during this study.
- Children are caries free at time of the study.
- Children with no regular use of chewing xylitol gum.
- Children without orthodontic appliance.
- Children are not using fluoride tooth paste or any topical fluoride application at time of study.
- Children who have dental plaque.
Who cannot join
- Uncooperative children.
- Children with history of allergy to dental products or their products
- Parents refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Microbiological Effects of Three Different Mouth Rinses Made of Sodium Fluoride, Guava Leaves Extract or Pomegranate Peel Extract on Dental Plaque in Children
Dental plaque is a major problem in the field of oral and dental health and its prevention is more important to avoid dental caries and gingival diseases. Mouth washes are very useful in the reduction of microbial plaque and gingival inflammation. Sodium fluoride mouth wash is one of the ways that prevent dental plaque. Recently, using herbal products are efficient in decreasing dental plaque. Pomegranate peels and Guava leaves extracts are an essential medicinal plant with various pharmacological properties.
Aim of study: To evaluate and compare the efficiency of different mouth rinses (sodium fluoride mouth rinse, guava leaves aqueous extract and pomegranate aqueous extract) on dental plaque in children, clinically by measuring gingival and plaque indices scores and microbiologically by measuring of streptococcus mutans and lactobacillus.
Read more
Materials and methods: forty apparently healthy and cooperative children were selected from the Outpatient Dental Clinic of Pediatric dentistry Department, Faculty of Dentistry, Suez Canal University. Children were randomly divided into three groups as follows:
Group (I):10 children will rinse with sodium fluoride, Group (II): 10 children will rinse with guava leaves aqueous extract and Group (III):10 children will rinse with pomegranate peels aqueous extract. Group (IV):10 children will rinse with water (control group). Instructions for oral hygiene and using mouth wash will be demonstrated for every child. Clinical and microbiological examinations will be done firstly at day one before using any type of examined mouthwashes (0-base line), then clinical and microbiological follow up will be done after 7 and 15 days of using different mouthwash for each group.
- Conditions
- Gingival Diseases
- Being tested
- sodium fluoride solution, guava leaves aqueous extract, pomegranate peel aqueous extrac, Distilled water
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium fluoride solutionDrug
sodium fluoride solution mouth rinse (0.2%).
guava leaves aqueous extractDrug
guava leaves aqueous extract mouth rinse (0.5%)
pomegranate peel aqueous extracDrug
pomegranate peel aqueous extract mouth rinse (0.5%).
Distilled waterOther
placebo distilled water
| Study group | Role | What they receive |
|---|---|---|
| sodium fluoride solution | Active comparator | children will rinse with sodium fluoride solution mouth rinse (0.2%). Receives: Drug: sodium fluoride solution |
| guava leaves | Active comparator | children will rinse with guava leaves aqueous extract mouth rinse (0.5%). Receives: Drug: guava leaves aqueous extract |
| pomegranate peel | Active comparator | children will rinse with pomegranate peel aqueous extract mouth rinse (0.5%). Receives: Drug: pomegranate peel aqueous extrac |
| Control | Placebo comparator | children will rinse with distilled water Receives: Other: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival health
gingival index score from 0 to 3, where 0 normal gingiva and 3 severe inflammation
Measured: baseline , after 7 days and after 15 days
plaque accumulation and pocket depth
plaque index score from 0 to 3, where 0 no plaque and 3 abundance of soft matter within gingival pocket
Measured: baseline , after 7 days and after 15 days
streptococcus mutans and lactobacilli count
calculate the counts of streptococcus mutans and lactobacilli
Measured: baseline , after 7 days and after 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start17 Feb 2020
- Primary completion15 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival DiseasesStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013735
- Sponsor's protocol ID
- 241/2019
- Status last verified
- Sep 2021
- First submitted
- 8 Jul 2023
- Last updated
- 28 Aug 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 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Effects of Three Different Mouth Rinses Made of Sodium Fluoride, Guava Leaves Extract or Pomegranate Peel Extract on Dental Plaque in Children
- ClinicalTrials.gov ID
- NCT06013735
- Acronym / sponsor ID
- 241/2019
- Conditions
- Gingival Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 28 Aug 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.
Dental plaque is a major problem in the field of oral and dental health and its prevention is more important to avoid dental caries and gingival diseases. Mouth washes are very useful in the reduction of microbial plaque and gingival inflammation. Sodium fluoride mouth wash is one of the ways that prevent dental plaque. Recently, using herbal products are efficient in decreasing dental plaque. Pomegranate peels and Guava leaves extracts are an essential medicinal plant with various pharmacological properties.
Aim of study: To evaluate and compare the efficiency of different mouth rinses (sodium fluoride mouth rinse, guava leaves aqueous extract and pomegranate aqueous extract) on dental plaque in children, clinically by measuring gingival and plaque indices scores and microbiologically by measuring of streptococcus mutans and lactobacillus.
Materials and methods: forty apparently healthy and cooperative children were selected from the Outpatient Dental Clinic of Pediatric dentistry Department, Faculty of Dentistry, Suez Canal University. Children were randomly divided into three groups as follows:
Group (I):10 children will rinse with sodium fluoride, Group (II): 10 children will rinse with guava leaves aqueous extract and Group (III):10 children will rinse with pomegranate peels aqueous extract. Group (IV):10 children will rinse with water (control group). Instructions for oral hygiene and using mouth wash will be demonstrated for every child. Clinical and microbiological examinations will be done firstly at day one before using any type of examined mouthwashes (0-base line), then clinical and microbiological follow up will be done after 7 and 15 days of using different mouthwash for each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sodium fluoride solution | Active comparator | Drug: sodium fluoride solutionchildren will rinse with sodium fluoride solution mouth rinse (0.2%). |
| guava leaves | Active comparator | Drug: guava leaves aqueous extractchildren will rinse with guava leaves aqueous extract mouth rinse (0.5%). |
| pomegranate peel | Active comparator | Drug: pomegranate peel aqueous extracchildren will rinse with pomegranate peel aqueous extract mouth rinse (0.5%). |
| Control | Placebo comparator | Other: Distilled waterchildren will rinse with distilled water |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children are apparently healthy.
- Their age's ranges from 6-12 years {mixed dentition}, First permanent molars were fully erupted.
- Children are not taking antibiotics, steroids and inflammatory therapy for two weeks before study or during this study.
- Children are caries free at time of the study.
- Children with no regular use of chewing xylitol gum.
Key exclusion criteria (3 listed)
- Uncooperative children.
- Children with history of allergy to dental products or their products
- Parents refusal.
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 |
|---|---|---|
| sodium fluoride solutionsodium fluoride solution mouth rinse (0.2%). | Drug | sodium fluoride solution |
| guava leaves aqueous extractguava leaves aqueous extract mouth rinse (0.5%) | Drug | guava leaves |
| pomegranate peel aqueous extracpomegranate peel aqueous extract mouth rinse (0.5%). | Drug | pomegranate peel |
| Distilled waterplacebo distilled water | Other | Control |
Primary outcome
Gingival health
Time frame: baseline , after 7 days and after 15 days
gingival index score from 0 to 3, where 0 normal gingiva and 3 severe inflammation
plaque accumulation and pocket depth
Time frame: baseline , after 7 days and after 15 days
plaque index score from 0 to 3, where 0 no plaque and 3 abundance of soft matter within gingival pocket
streptococcus mutans and lactobacilli count
Time frame: baseline , after 7 days and after 15 days
calculate the counts of streptococcus mutans and lactobacilli
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 28 Aug 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.
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 study testing sodium fluoride solution, guava leaves aqueous extract and pomegranate peel aqueous extrac in people with Gingival Diseases, run by Suez Canal University at 1 site in Egypt.
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 8 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: finished, as of the sponsor's last update on 28 Aug 2023. 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 Egypt. 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.
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?
Gingival health (time frame: baseline , after 7 days and after 15 days). 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 28 Aug 2023.