Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans

August 17, 2021 updated by: Julieta María Méndez Romero

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Paraguay
    • International
      • Coronel Oviedo, International, Paraguay, 595
        • Facultad de Odontología Universidad Nacional de Caaguazú

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants that signed the informed consent

Exclusion Criteria:

  • allergic to carica papaya
  • ongoing medical or dental treatment that could interfere with the results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carica Papaya extract
Carica Papaya at 3%
Other: CARICA PAPAYA MOUTHWASH
Each application was 10 ml. applied for 1 minute, once a day for 8 days
Active Comparator: Chlorhexidine
0.12% chlorhexidine mouthwash formulation (commercially available)
Other: CHLORHEXIDINE MOUTHWASH
Each application was 10 ml. applied for 1 minute, once a day for 8 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Colony Forming units (Stage 1)
Time Frame: thorough study completion, an average of 24 hours
Before Intervention
thorough study completion, an average of 24 hours
Number of Colony Forming units (Stage 2)
Time Frame: 10 minutes after mouthwash use
After Intervention
10 minutes after mouthwash use
Number of Colony Forming units (Stage 3)
Time Frame: 8 days after mouthwash use
After Intervention
8 days after mouthwash use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julieta María Méndez Romero

Investigators

  • Principal Investigator: Diego Céspedes, Facultad de Odontología, Universidad nacional de Caaguazu
  • Study Director: Ulises A Villasanti Torales, Facultad de Odontología, Universidad nacional de Caaguazu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2017

Primary Completion (Actual)

October 21, 2017

Study Completion (Actual)

October 21, 2017

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

By email

IPD Sharing Time Frame

From the time the protocol is available in clinical trials.gov and with no limit of time

IPD Sharing Access Criteria

Researchers that want to know about the study and use the protocol

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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