NCT04485520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

July 21, 2020

Last Update Submit

August 17, 2021

Conditions

Keywords

Salivadental plaquestreptococcus mutans

Outcome Measures

Primary Outcomes (3)

  • Number of Colony Forming units (Stage 1)

    Before Intervention

    thorough study completion, an average of 24 hours

  • Number of Colony Forming units (Stage 2)

    After Intervention

    10 minutes after mouthwash use

  • Number of Colony Forming units (Stage 3)

    After Intervention

    8 days after mouthwash use

Study Arms (2)

Carica Papaya extract

EXPERIMENTAL

Carica Papaya at 3%

Other: CARICA PAPAYA MOUTHWASH

Chlorhexidine

ACTIVE COMPARATOR

0.12% chlorhexidine mouthwash formulation (commercially available)

Other: CHLORHEXIDINE MOUTHWASH

Interventions

Each application was 10 ml. applied for 1 minute, once a day for 8 days

Carica Papaya extract

Each application was 10 ml. applied for 1 minute, once a day for 8 days

Chlorhexidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants that signed the informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Odontología Universidad Nacional de Caaguazú

Coronel Oviedo, International, 595, Paraguay

Location

Related Publications (1)

  • 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.

    PMID: 30486374BACKGROUND

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Diego Céspedes

    Facultad de Odontología, Universidad Nacional de Caaguazu

    PRINCIPAL INVESTIGATOR
  • Ulises A Villasanti Torales

    Facultad de Odontologia, Universidad Nacional de Caaguazu

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Writting and Publication Department, Regional Health Research Institute

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 24, 2020

Study Start

September 21, 2017

Primary Completion

October 21, 2017

Study Completion

October 21, 2017

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

By email

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
From the time the protocol is available in clinical trials.gov and with no limit of time
Access Criteria
Researchers that want to know about the study and use the protocol

Locations