NCT03773094

Brief Summary

This trial is to test the antibacterial effect of Guava leaves extract mouth wash compared to Chlorhexidine mouth wash in high caries risk patients. Also salivary pH and patient satisfaction to taste will also be tested.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_2

Status
unknown

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

First Submitted

Initial submission to the registry

December 8, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

December 8, 2018

Last Update Submit

December 11, 2018

Conditions

High Caries Risk PatientsAntimicrobial EffectSalivary pHPatient Satisfaction to Taste

Outcome Measures

Primary Outcomes (1)

  • Anti-bacterial effect against streptococcus mutans

    Antimicrobial effect against streptococcus mutans: saliva samples collected and total bacterial count measured after agar plates incubating, expressed in colony forming units

    3 months

Secondary Outcomes (1)

  • Salivary pH

    3 months

Other Outcomes (1)

  • Patient satisfaction to taste: questionnaire

    3 months

Study Arms (2)

Guava leaves extract

EXPERIMENTAL

A natural product that is prepared as a mouthwash

Drug: Guava leaves extract

Chlorhexidine

ACTIVE COMPARATOR

chemical agent Chlorhexidine as a mouthwash

Drug: Chlorhexidine

Interventions

Guava leaves extractDRUG

Natural product : The leaves of the guava tree are full of antioxidants, anti-inflammatory agents, antibacterials, and even tannins that can have significant health benefits, from treating stomach troubles to chronic diseases like cancer •

Also known as: Psidium guajava
Guava leaves extract
ChlorhexidineDRUG

chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard

Also known as: Chlorhexidine glucnate
Chlorhexidine

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • High caries risk patients
  • years
  • Healthy cooperative patients
  • Males or Females

You may not qualify if:

  • Medically compromised patients
  • Patients with any systemic disease that might affect the salivary flow
  • Allergy to any of the ingredients
  • Patients with physical limitations that might affect normal tooth brushing and mouth rinsing
  • Presence of intraoral infections
  • Currently using any mouth rinse
  • Smokers
  • Use of antibiotics in the previous 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Gupta D, Nayan S, Tippanawar HK, Patil GI, Jain A, Momin RK, Gupta RK. Are herbal mouthwash efficacious over chlorhexidine on the dental plaque? Pharmacognosy Res. 2015 Jul-Sep;7(3):277-81. doi: 10.4103/0974-8490.155874.

    PMID: 26130940BACKGROUND

  • Ravi K, Divyashree P. Psidium guajava: A review on its potential as an adjunct in treating periodontal disease. Pharmacogn Rev. 2014 Jul;8(16):96-100. doi: 10.4103/0973-7847.134233.

    PMID: 25125881BACKGROUND

  • Singla S, Malhotra R, Nd S, Saxena S. Antibacterial Efficacy of Mouthwash Prepared from Pomegranate, Grape Seed and Guava Extracts against Oral Streptococci: An in Vivo Study. J Clin Pediatr Dent. 2018;42(2):109-113. doi: 10.17796/1053-4628-42.2.5. Epub 2017 Oct 31.

    PMID: 29087796BACKGROUND

  • Shah S, Bargale S, Dave BH, Deshpande A, Kariya PB, Karri A. Comparison of Antimicrobial Efficacy of (between) 0.2% Chlorhexidine and Herbal Mouthwash on Salivary Streptococcus mutans: A Randomized Controlled Pilot Study. Contemp Clin Dent. 2018 Jul-Sep;9(3):440-445. doi: 10.4103/ccd.ccd_264_18.

    PMID: 30166841BACKGROUND

  • Jain I, Jain P. Comparative evaluation of antimicrobial efficacy of three different formulations of mouth rinses with multi-herbal mouth rinse. J Indian Soc Pedod Prev Dent. 2016 Oct-Dec;34(4):315-23. doi: 10.4103/0970-4388.191409.

    PMID: 27681394BACKGROUND

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Engy MM Kassem, Master's degree

CONTACT

00201000687726engy.mostafa@dentistry.cu.edu.eg

Mohamed A Khairy, PhD

CONTACT

madelkhairy@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

December 8, 2018

First Posted

December 12, 2018

Study Start

January 1, 2019

Primary Completion

November 1, 2019

Study Completion

January 1, 2020

Last Updated

December 12, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share