GingivitisPhase 3NCT05951647
The Effect of Pomegranate Peel, German Chamomile or Their Combination on Gingivitis
A Phase 3 study testing Chamomile extract mouthwash, Pomegranate peel extract mouth wash and Combination of 5% chamomile extract and pomegranate peel extract mouthwash in people with Gingivitis, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of this study is to compare clinically and biochemically the effect of herbal mouthwashes containing German chamomile and pomegranate peel extracts individually and as a mixture to chlorohexidine mouthwash in the treatment of gingivitis. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- Chamomile extract mouthwash, Pomegranate peel extract mouth wash and Combination of 5% chamomile extract and pomegranate peel extract mouthwash
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jul 2023to Nov 2023
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 25-50
- Patients with plaque induced gingivitis.
Who cannot join
- Patients with systemic diseases (diabetes, leukemia, anemia)
- Smokers
- Pregnant females
- Patients receiving orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Pharmacy, Alexandria University
Alexandria, 21521
Noha A Hamdy, PhD, 1005182151 ext. +20, noha.alaaeldine@alexu.edu.eg
About this study
Official title: The Effect of Mouthwashes Containing Pomegranate Peel, German Chamomile or Their Combination in the Treatment of Gingivitis
The aim of this study is to compare clinically and biochemically the effect of herbal mouthwashes containing German chamomile and pomegranate peel extracts individually and as a mixture to chlorohexidine mouthwash in the treatment of gingivitis. The response will be assessed clinically and by suitable biochemical parameters.
Read the detailed description
- Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine and Faculty of Dentistry, Alexandria University
- All participants should agree to take part in this clinical study and will provide informed consent.
- Sixty plaque induced gingivitis patients ,will be recruited from Faculty of Dentistry, Alexandria University.
- The 60 participants will be randomly assigned into 5 groups. Group 1: Patients will be managed by scaling. Group 2: Patients will be managed by scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily. Group 3: Patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily. Group 4: Patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily. Group 5: Patients will be managed by scaling and will use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily.
- All patients will be submitted to:
- Full patient history and clinical examination.
- Gingival index will be measured
- Saliva samples will be obtained in order to conduct ELISA for the selected biomarkers.
- Different mouthwashes will be provided to patients.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
- Conditions
- Gingivitis
- Being tested
- Chamomile extract mouthwash, Pomegranate peel extract mouth wash, Combination of 5% chamomile extract and pomegranate peel extract mouthwash, Scaling, Scaling and Chlorohexidine mouthwash
- Keywords
- Pomegranate peel, German chamomile, TNF-α, IL-1β
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chamomile extract mouthwashDrug
5% chamomile extract mouthwash in a dose of 15 ml twice daily.
Pomegranate peel extract mouth washDrug
5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily.
Combination of 5% chamomile extract and pomegranate peel extract mouthwashDrug
Use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily.
ScalingProcedure or surgery
Patients will be managed by scaling
Scaling and Chlorohexidine mouthwashDrug
scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Scaling | Placebo comparator | 12 patients will be managed by scaling only Receives: Procedure: Scaling |
| Scaling and Chlorohexidine mouthwash | Active comparator | Patients will be managed by scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily. Receives: Drug: Scaling and Chlorohexidine mouthwash |
| Scaling and Chamomile extract mouthwash | Experimental | Patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily. Receives: Drug: Chamomile extract mouthwash |
| Scaling and Pomegranate peel extract mouthwash | Experimental | Patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily. Receives: Drug: Pomegranate peel extract mouth wash |
| Scaling and Chamomile extract mixed with Pomegranate peel extract mouthwash | Experimental | Patients will be managed by scaling and will use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily. Receives: Drug: Combination of 5% chamomile extract and pomegranate peel extract mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment for the gingival index (GI)
The gingival index will measured before treatment, 7 days, and 15 days after treatment respectively.
Measured: 15 days
Secondary outcomes (2)
Measurement of TNF-α saliva level
TNF-α saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively.
Measured: 15 days
Measurement of IL1β saliva level
IL1β saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start11 Jul 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
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.
- More trials run by Alexandria 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, parallel, randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eman Sh Anwar, PhD, Principal investigator, Faculty of Pharmacy, Alexandria UniversityMaha R Taalab, PhD, Principal investigator, Alexandria UniversityDoaa A Ghareeb, PhD, Principal investigator, Faculty of Science, Alexandria UniversityNoha A Hamdy, PhD, Principal investigator, Faculty of Pharmacy, Alexandria UniversityMarwa A Alashwah, PharmD, Principal investigator, Faculty of Pharmacy, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951647
- Sponsor's protocol ID
- 0107722
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mouthwashes Containing Pomegranate Peel, German Chamomile or Their Combination in the Treatment of Gingivitis
- ClinicalTrials.gov ID
- NCT05951647
- Acronym / sponsor ID
- 0107722
- Conditions
- Gingivitis
- Keywords
- Pomegranate peel, German chamomile, TNF-α, IL-1β
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 11 Jul 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 19 Jul 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.
The aim of this study is to compare clinically and biochemically the effect of herbal mouthwashes containing German chamomile and pomegranate peel extracts individually and as a mixture to chlorohexidine mouthwash in the treatment of gingivitis. The response will be assessed clinically and by suitable biochemical parameters.
Detailed description
- Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine and Faculty of Dentistry, Alexandria University
- All participants should agree to take part in this clinical study and will provide informed consent.
- Sixty plaque induced gingivitis patients ,will be recruited from Faculty of Dentistry, Alexandria University.
- The 60 participants will be randomly assigned into 5 groups. Group 1: Patients will be managed by scaling. Group 2: Patients will be managed by scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily. Group 3: Patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily. Group 4: Patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily. Group 5: Patients will be managed by scaling and will use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily.
- All patients will be submitted to:
- Full patient history and clinical examination.
- Gingival index will be measured
- Saliva samples will be obtained in order to conduct ELISA for the selected biomarkers.
- Different mouthwashes will be provided to patients.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
- Model description
- Double-blinded, parallel, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Scaling | Placebo comparator | Procedure: Scaling12 patients will be managed by scaling only |
| Scaling and Chlorohexidine mouthwash | Active comparator | Drug: Scaling and Chlorohexidine mouthwashPatients will be managed by scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily. |
| Scaling and Chamomile extract mouthwash | Experimental | Drug: Chamomile extract mouthwashPatients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily. |
| Scaling and Pomegranate peel extract mouthwash | Experimental | Drug: Pomegranate peel extract mouth washPatients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily. |
| Scaling and Chamomile extract mixed with Pomegranate peel extract mouthwash | Experimental | Drug: Combination of 5% chamomile extract and pomegranate peel extract mouthwashPatients will be managed by scaling and will use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 25-50
- Patients with plaque induced gingivitis.
Key exclusion criteria (4 listed)
- Patients with systemic diseases (diabetes, leukemia, anemia)
- Smokers
- Pregnant females
- Patients receiving orthodontic treatment
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 |
|---|---|---|
| Chamomile extract mouthwash5% chamomile extract mouthwash in a dose of 15 ml twice daily. | Drug | Scaling and Chamomile extract mouthwash |
| Pomegranate peel extract mouth wash5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily. | Drug | Scaling and Pomegranate peel extract mouthwash |
| Combination of 5% chamomile extract and pomegranate peel extract mouthwashUse a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily. | Drug | Scaling and Chamomile extract mixed with Pomegranate peel extract mouthwash |
| ScalingPatients will be managed by scaling | Procedure or surgery | Scaling |
| Scaling and Chlorohexidine mouthwashscaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily. | Drug | Scaling and Chlorohexidine mouthwash |
Primary outcome
Clinical assessment for the gingival index (GI)
Time frame: 15 days
The gingival index will measured before treatment, 7 days, and 15 days after treatment respectively.
2 secondary outcomes
Measurement of TNF-α saliva level
Time frame: 15 days
Measurement of IL1β saliva level
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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.
Eman Sh Anwar, PhD principal investigator
Faculty of Pharmacy, Alexandria University
Maha R Taalab, PhD principal investigator
Alexandria University
Doaa A Ghareeb, PhD principal investigator
Faculty of Science, Alexandria University
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 Chamomile extract mouthwash, Pomegranate peel extract mouth wash and Combination of 5% chamomile extract and pomegranate peel extract mouthwash in people with Gingivitis, run by Alexandria 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 2 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 19 Jul 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha A Hamdy, PhD (1005182151 ext. +20, noha.alaaeldine@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment for the gingival index (GI) (time frame: 15 days). 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 19 Jul 2023.