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

Primary Purpose

Streptococcus, Other Specified Group, Dental Plaque

Status
Completed
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
CARICA PAPAYA MOUTHWASH
CHLORHEXIDINE MOUTHWASH
Sponsored by
Julieta María Méndez Romero
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Streptococcus, Other Specified Group focused on measuring Saliva, dental plaque, streptococcus mutans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Facultad de Odontología Universidad Nacional de Caaguazú

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carica Papaya extract

Chlorhexidine

Arm Description

Carica Papaya at 3%

0.12% chlorhexidine mouthwash formulation (commercially available)

Outcomes

Primary Outcome Measures

Number of Colony Forming units (Stage 1)
Before Intervention
Number of Colony Forming units (Stage 2)
After Intervention
Number of Colony Forming units (Stage 3)
After Intervention

Secondary Outcome Measures

Full Information

First Posted
July 21, 2020
Last Updated
August 17, 2021
Sponsor
Julieta María Méndez Romero
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1. Study Identification

Unique Protocol Identification Number
NCT04485520
Brief Title
Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
October 21, 2017 (Actual)
Study Completion Date
October 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julieta María Méndez Romero

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcus, Other Specified Group, Dental Plaque
Keywords
Saliva, dental plaque, streptococcus mutans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carica Papaya extract
Arm Type
Experimental
Arm Description
Carica Papaya at 3%
Arm Title
Chlorhexidine
Arm Type
Active Comparator
Arm Description
0.12% chlorhexidine mouthwash formulation (commercially available)
Intervention Type
Other
Intervention Name(s)
CARICA PAPAYA MOUTHWASH
Intervention Description
Each application was 10 ml. applied for 1 minute, once a day for 8 days
Intervention Type
Other
Intervention Name(s)
CHLORHEXIDINE MOUTHWASH
Intervention Description
Each application was 10 ml. applied for 1 minute, once a day for 8 days
Primary Outcome Measure Information:
Title
Number of Colony Forming units (Stage 1)
Description
Before Intervention
Time Frame
thorough study completion, an average of 24 hours
Title
Number of Colony Forming units (Stage 2)
Description
After Intervention
Time Frame
10 minutes after mouthwash use
Title
Number of Colony Forming units (Stage 3)
Description
After Intervention
Time Frame
8 days after mouthwash use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Céspedes
Organizational Affiliation
Facultad de Odontología, Universidad Nacional de Caaguazu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulises A Villasanti Torales
Organizational Affiliation
Facultad de Odontologia, Universidad Nacional de Caaguazu
Official's Role
Study Director
Facility Information:
Facility Name
Facultad de Odontología Universidad Nacional de Caaguazú
City
Coronel Oviedo
State/Province
International
ZIP/Postal Code
595
Country
Paraguay

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30486374
Citation
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.
Results Reference
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Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans

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