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

Sponsor

Julieta María Méndez Romero (Other)

Overall Status

Completed

CT.gov ID

NCT04485520

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

40.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Streptococcus, Other Specified Group Dental Plaque	Other: CARICA PAPAYA MOUTHWASH Other: CHLORHEXIDINE MOUTHWASH	N/A

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

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Sep 21, 2017

Actual Primary Completion Date :

Oct 21, 2017

Actual Study Completion Date :

Oct 21, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of Colony Forming units (Stage 1) [thorough study completion, an average of 24 hours]
Before Intervention
Number of Colony Forming units (Stage 2) [10 minutes after mouthwash use]
After Intervention
Number of Colony Forming units (Stage 3) [8 days after mouthwash use]
After Intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Facultad de Odontología Universidad Nacional de Caaguazú	Coronel Oviedo	International	Paraguay	595

Sponsors and Collaborators

Julieta María Méndez Romero

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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). pii: E2660. doi: 10.3390/ijerph15122660.

Responsible Party:

Julieta María Méndez Romero, Head of Writting and Publication Department, Regional Health Research Institute, Universidad Nacional de Caaguazu

ClinicalTrials.gov Identifier:

NCT04485520

Other Study ID Numbers:

00140

First Posted:

Jul 24, 2020

Last Update Posted:

Aug 18, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Julieta María Méndez Romero, Head of Writting and Publication Department, Regional Health Research Institute, Universidad Nacional de Caaguazu

Saliva

dental plaque

streptococcus mutans

Additional relevant MeSH terms:

Dental Plaque

Chlorhexidine

Study Results

No Results Posted as of Aug 18, 2021