Streptococcus, Other Specified GroupNCT04485520
Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans
A study testing CARICA PAPAYA MOUTHWASH and CHLORHEXIDINE MOUTHWASH in people with Streptococcus, Other Specified Group and Dental Plaque, run by Julieta María Méndez Romero at 1 site in Paraguay.
Trial summary
Papaya has effects on oral pathogenic microorganisms, it also has anticoagulant quality, amebicidal action, antimicrobial, bacteriostatic and antifungal activity on different bacteria, especially on Streptococcus mutans, this can be exploited in the dental area. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Streptococcus, Other Specified Group, Dental Plaque
- What is being tested?
- CARICA PAPAYA MOUTHWASH and CHLORHEXIDINE MOUTHWASH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteParaguay
- Study dates
- 21 Sep 2017to 21 Oct 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants that signed the informed consent
Who cannot join
- allergic to carica papaya
- ongoing medical or dental treatment that could interfere with the results.
Trial locations and contacts
1 site in 1 country.
Paraguay1 site
Facultad de Odontología Universidad Nacional de Caaguazú
Coronel Oviedo, International, 595
About this study
Official title: Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans in Students of the Faculty of Dentistry in the Year 2018
Papaya has effects on oral pathogenic microorganisms, it also has anticoagulant quality, amebicidal action, antimicrobial, bacteriostatic and antifungal activity on different bacteria, especially on Streptococcus mutans, this can be exploited in the dental area. The objective of the study was to determine the efficacy of Carica Papaya peel extract (suckling) as an inhibitor of Streptococcus Mutans in students of the dental faculty of the National University of Caaguazú in 2018.
Read the detailed description
Specific objectives
- To determine the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on Streptococcus Mutans by age and sex grouping.
- To quantify the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on the growth of Streptococcus Mutans before, at 10 minutes and 8 days of use in the experimental group.
- Quantify the inhibition of 0.12% Chlorhexidine Gluconate on the growth of Streptococcus Mutans before, after 10 minutes and 8 days of use in the control group.
- Compare the count of Colony Forming Units (CFU) between both groups.
- Being tested
- CARICA PAPAYA MOUTHWASH, CHLORHEXIDINE MOUTHWASH
- Keywords
- Saliva, dental plaque, streptococcus mutans
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARICA PAPAYA MOUTHWASHOther
Each application was 10 ml. applied for 1 minute, once a day for 8 days
CHLORHEXIDINE MOUTHWASHOther
Each application was 10 ml. applied for 1 minute, once a day for 8 days
| Study group | Role | What they receive |
|---|---|---|
| Carica Papaya extract | Experimental | Carica Papaya at 3% Receives: Other: CARICA PAPAYA MOUTHWASH |
| Chlorhexidine | Active comparator | 0.12% chlorhexidine mouthwash formulation (commercially available) Receives: Other: CHLORHEXIDINE MOUTHWASH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Colony Forming units (Stage 1)
Before Intervention
Measured: thorough study completion, an average of 24 hours
Number of Colony Forming units (Stage 2)
After Intervention
Measured: 10 minutes after mouthwash use
Number of Colony Forming units (Stage 3)
After Intervention
Measured: 8 days after mouthwash use
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 start21 Sep 2017
- Primary completion21 Oct 2017
- Study completion21 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Streptococcus, Other Specified GroupStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julieta María Méndez Romero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julieta María Méndez Romero, Universidad Nacional de Caaguazu
- Investigators
- Diego Céspedes, Principal investigator, Facultad de Odontología, Universidad Nacional de CaaguazuUlises A Villasanti Torales, Study director, Facultad de Odontologia, Universidad Nacional de Caaguazu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485520
- Sponsor's protocol ID
- 00140
- Status last verified
- Aug 2021
- First submitted
- 21 Jul 2020
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By email
Publications
Saliasi I, Llodra JC, Bravo M, Tramini P, Dussart C, Viennot S, Carrouel F. Effect of a Toothpaste/Mouthwash Containing Carica papaya Leaf Extract on Interdental Gingival Bleeding: A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Nov 27;15(12):2660. doi: 10.3390/ijerph15122660.
PubMed 30486374
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans in Students of the Faculty of Dentistry in the Year 2018
- ClinicalTrials.gov ID
- NCT04485520
- Acronym / sponsor ID
- 00140
- Keywords
- Saliva, dental plaque, streptococcus mutans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Julieta María Méndez RomeroUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 21 Oct 2017 (actual)
- Study completion
- 21 Oct 2017 (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.
Papaya has effects on oral pathogenic microorganisms, it also has anticoagulant quality, amebicidal action, antimicrobial, bacteriostatic and antifungal activity on different bacteria, especially on Streptococcus mutans, this can be exploited in the dental area. The objective of the study was to determine the efficacy of Carica Papaya peel extract (suckling) as an inhibitor of Streptococcus Mutans in students of the dental faculty of the National University of Caaguazú in 2018.
Detailed description
Specific objectives
- To determine the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on Streptococcus Mutans by age and sex grouping.
- To quantify the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on the growth of Streptococcus Mutans before, at 10 minutes and 8 days of use in the experimental group.
- Quantify the inhibition of 0.12% Chlorhexidine Gluconate on the growth of Streptococcus Mutans before, after 10 minutes and 8 days of use in the control group.
- Compare the count of Colony Forming Units (CFU) between both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carica Papaya extract | Experimental | Other: CARICA PAPAYA MOUTHWASHCarica Papaya at 3% |
| Chlorhexidine | Active comparator | Other: CHLORHEXIDINE MOUTHWASH0.12% chlorhexidine mouthwash formulation (commercially available) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants that signed the informed consent
Key exclusion criteria (2 listed)
- allergic to carica papaya
- ongoing medical or dental treatment that could interfere with the results.
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 |
|---|---|---|
| CARICA PAPAYA MOUTHWASHEach application was 10 ml. applied for 1 minute, once a day for 8 days | Other | Carica Papaya extract |
| CHLORHEXIDINE MOUTHWASHEach application was 10 ml. applied for 1 minute, once a day for 8 days | Other | Chlorhexidine |
Primary outcome
Number of Colony Forming units (Stage 1)
Time frame: thorough study completion, an average of 24 hours
Before Intervention
Number of Colony Forming units (Stage 2)
Time frame: 10 minutes after mouthwash use
After Intervention
Number of Colony Forming units (Stage 3)
Time frame: 8 days after mouthwash use
After Intervention
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 18 Aug 2021.
- Background: PubMed 30486374Saliasi I, Llodra JC, Bravo M, Tramini P, Dussart C, Viennot S, Carrouel F. Effect of a Toothpaste/Mouthwash Containing Carica papaya Leaf Extract on Interdental Gingival Bleeding: A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Nov 27;15(12):2660. doi: 10.3390/ijerph15122660.
- Individual participant dataSharing planned: Yes. By email
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.
Diego Céspedes principal investigator
Facultad de Odontología, Universidad Nacional de Caaguazu
Ulises A Villasanti Torales study director
Facultad de Odontologia, Universidad Nacional de Caaguazu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARICA PAPAYA MOUTHWASH and CHLORHEXIDINE MOUTHWASH in people with Streptococcus, Other Specified Group and Dental Plaque, run by Julieta María Méndez Romero at 1 site in Paraguay.
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 1 inclusion and 2 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 18 Aug 2021. 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 Paraguay. 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. 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?
Number of Colony Forming units (Stage 1) (time frame: thorough study completion, an average of 24 hours). 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?
On the ClinicalTrials.gov record for NCT04485520, which also lists 1 linked publication.
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 18 Aug 2021.