High Caries Risk PatientsPhase 2/3NCT03773094
Antibacterial Effect of Guava Leaves Extract Mouthwash Compared to Chlorhexidine Mouthwash in High Caries Risk Patients
A Phase 2/3 study testing Guava leaves extract and Chlorhexidine in people with High Caries Risk Patients and Antimicrobial Effect, run by Cairo University.
Trial summary
This trial is to test the antibacterial effect of Guava leaves extract mouth wash compared to Chlorhexidine mouth wash in high caries risk patients. Also salivary pH and patient satisfaction to taste will also be tested. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- High Caries Risk Patients, Antimicrobial Effect, Salivary pH
- What is being tested?
- Guava leaves extract and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Jan 2020
- Phase
- Phase 2/3
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- High caries risk patients
- 18-50 years
- Healthy cooperative patients
- Males or Females
Who cannot join
- Medically compromised patients
- Patients with any systemic disease that might affect the salivary flow
- Allergy to any of the ingredients
- Patients with physical limitations that might affect normal tooth brushing and mouth rinsing
- Presence of intraoral infections
- Currently using any mouth rinse
- Smokers
- Use of antibiotics in the previous 30 days
Trial locations and contacts
No sites are listed yet.
Mohamed A Khairy, PhD contact
About this study
Official title: Effect of Guava Leaves Extract Mouth Wash on Antibacterial Activity, Salivary pH and Patient Satisfaction Compared to Chlorhexidine Mouth Wash in High Caries Risk Patients: A Randomized Control Clinical Trial
This trial is to test the antibacterial effect of Guava leaves extract mouth wash compared to Chlorhexidine mouth wash in high caries risk patients.
Also salivary pH and patient satisfaction to taste will also be tested.
Read the detailed description
This study is conducted to evaluate the effect of Guava leaves extract mouth wash on anti-bacterial activity against streptococcus mutans, salivary pH and patient satisfaction to taste compared to Chlorhexidine mouth wash.
P: Population with high caries risk patients I: Intervention by Guava leaves extract mouthwash C: Control is Chlorhexidine mouthwash O1: The primary outcome is antibacterial activity. O2: The secondary outcome is salivary pH O3: The tertiary outcome is patient satisfaction to taste
- Conditions
- High Caries Risk Patients, Antimicrobial Effect, Salivary pH, Patient Satisfaction to Taste
- Being tested
- Guava leaves extract, Chlorhexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guava leaves extractDrug
Also called Psidium guajava
Natural product : The leaves of the guava tree are full of antioxidants, anti-inflammatory agents, antibacterials, and even tannins that can have significant health benefits, from treating stomach troubles to chronic diseases like cancer
•
ChlorhexidineDrug
Also called Chlorhexidine glucnate
chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard
| Study group | Role | What they receive |
|---|---|---|
| Guava leaves extract | Experimental | A natural product that is prepared as a mouthwash Receives: Drug: Guava leaves extract |
| Chlorhexidine | Active comparator | chemical agent Chlorhexidine as a mouthwash Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-bacterial effect against streptococcus mutans
Antimicrobial effect against streptococcus mutans: saliva samples collected and total bacterial count measured after agar plates incubating, expressed in colony forming units
Measured: 3 months
Secondary outcomes (1)
Salivary pH
Saliva samples pH will be measured using digital pH meter to evaluate its efficacy in preventing the action of acidogenic bacteria in high caries risk patients.
It displays numerical value.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study startJan 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for High Caries Risk PatientsStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy Mostafa Magdy Abdou Ahmed Kassem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773094
- Sponsor's protocol ID
- Guava leaves extract CHX
- Status last verified
- Dec 2018
- First submitted
- 8 Dec 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta D, Nayan S, Tippanawar HK, Patil GI, Jain A, Momin RK, Gupta RK. Are herbal mouthwash efficacious over chlorhexidine on the dental plaque? Pharmacognosy Res. 2015 Jul-Sep;7(3):277-81. doi: 10.4103/0974-8490.155874.
PubMed 26130940Ravi K, Divyashree P. Psidium guajava: A review on its potential as an adjunct in treating periodontal disease. Pharmacogn Rev. 2014 Jul;8(16):96-100. doi: 10.4103/0973-7847.134233.
PubMed 25125881Singla S, Malhotra R, Nd S, Saxena S. Antibacterial Efficacy of Mouthwash Prepared from Pomegranate, Grape Seed and Guava Extracts against Oral Streptococci: An in Vivo Study. J Clin Pediatr Dent. 2018;42(2):109-113. doi: 10.17796/1053-4628-42.2.5. Epub 2017 Oct 31.
PubMed 29087796Shah S, Bargale S, Dave BH, Deshpande A, Kariya PB, Karri A. Comparison of Antimicrobial Efficacy of (between) 0.2% Chlorhexidine and Herbal Mouthwash on Salivary Streptococcus mutans: A Randomized Controlled Pilot Study. Contemp Clin Dent. 2018 Jul-Sep;9(3):440-445. doi: 10.4103/ccd.ccd_264_18.
PubMed 30166841Jain I, Jain P. Comparative evaluation of antimicrobial efficacy of three different formulations of mouth rinses with multi-herbal mouth rinse. J Indian Soc Pedod Prev Dent. 2016 Oct-Dec;34(4):315-23. doi: 10.4103/0970-4388.191409.
PubMed 27681394
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Guava Leaves Extract Mouth Wash on Antibacterial Activity, Salivary pH and Patient Satisfaction Compared to Chlorhexidine Mouth Wash in High Caries Risk Patients: A Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT03773094
- Acronym / sponsor ID
- Guava leaves extract CHX
- Conditions
- High Caries Risk Patients, Antimicrobial Effect, Salivary pH, Patient Satisfaction to Taste
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 12 Dec 2018 (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 trial is to test the antibacterial effect of Guava leaves extract mouth wash compared to Chlorhexidine mouth wash in high caries risk patients.
Also salivary pH and patient satisfaction to taste will also be tested.
Detailed description
This study is conducted to evaluate the effect of Guava leaves extract mouth wash on anti-bacterial activity against streptococcus mutans, salivary pH and patient satisfaction to taste compared to Chlorhexidine mouth wash.
P: Population with high caries risk patients I: Intervention by Guava leaves extract mouthwash C: Control is Chlorhexidine mouthwash O1: The primary outcome is antibacterial activity. O2: The secondary outcome is salivary pH O3: The tertiary outcome is patient satisfaction to taste
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guava leaves extract | Experimental | Drug: Guava leaves extractA natural product that is prepared as a mouthwash |
| Chlorhexidine | Active comparator | Drug: Chlorhexidinechemical agent Chlorhexidine as a mouthwash |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- High caries risk patients
- 18-50 years
- Healthy cooperative patients
- Males or Females
Key exclusion criteria (8 listed)
- Medically compromised patients
- Patients with any systemic disease that might affect the salivary flow
- Allergy to any of the ingredients
- Patients with physical limitations that might affect normal tooth brushing and mouth rinsing
- Presence of intraoral infections
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 |
|---|---|---|
| Guava leaves extractAlso: Psidium guajavaNatural product : The leaves of the guava tree are full of antioxidants, anti-inflammatory agents, antibacterials, and even tannins that can have significant health benefits, from treating stomach troubles to chronic diseases like cancer • | Drug | Guava leaves extract |
| ChlorhexidineAlso: Chlorhexidine glucnatechemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard | Drug | Chlorhexidine |
Primary outcome
Anti-bacterial effect against streptococcus mutans
Time frame: 3 months
Antimicrobial effect against streptococcus mutans: saliva samples collected and total bacterial count measured after agar plates incubating, expressed in colony forming units
1 secondary outcome
Salivary pH
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Background: PubMed 26130940Gupta D, Nayan S, Tippanawar HK, Patil GI, Jain A, Momin RK, Gupta RK. Are herbal mouthwash efficacious over chlorhexidine on the dental plaque? Pharmacognosy Res. 2015 Jul-Sep;7(3):277-81. doi: 10.4103/0974-8490.155874.
- Background: PubMed 25125881Ravi K, Divyashree P. Psidium guajava: A review on its potential as an adjunct in treating periodontal disease. Pharmacogn Rev. 2014 Jul;8(16):96-100. doi: 10.4103/0973-7847.134233.
- Background: PubMed 29087796Singla S, Malhotra R, Nd S, Saxena S. Antibacterial Efficacy of Mouthwash Prepared from Pomegranate, Grape Seed and Guava Extracts against Oral Streptococci: An in Vivo Study. J Clin Pediatr Dent. 2018;42(2):109-113. doi: 10.17796/1053-4628-42.2.5. Epub 2017 Oct 31.
- Background: PubMed 30166841Shah S, Bargale S, Dave BH, Deshpande A, Kariya PB, Karri A. Comparison of Antimicrobial Efficacy of (between) 0.2% Chlorhexidine and Herbal Mouthwash on Salivary Streptococcus mutans: A Randomized Controlled Pilot Study. Contemp Clin Dent. 2018 Jul-Sep;9(3):440-445. doi: 10.4103/ccd.ccd_264_18.
- Background: PubMed 27681394Jain I, Jain P. Comparative evaluation of antimicrobial efficacy of three different formulations of mouth rinses with multi-herbal mouth rinse. J Indian Soc Pedod Prev Dent. 2016 Oct-Dec;34(4):315-23. doi: 10.4103/0970-4388.191409.
- 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. This study is not recruiting at the moment.
Mohamed A Khairy, PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Guava leaves extract and Chlorhexidine in people with High Caries Risk Patients and Antimicrobial Effect, 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 4 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: status not confirmed, as of the sponsor's last update on 12 Dec 2018. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Engy MM Kassem, Master's degree (00201000687726, engy.mostafa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-bacterial effect against streptococcus mutans (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03773094, which also lists 5 linked publications.
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 12 Dec 2018.