Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03773094
Other study ID # Guava leaves extract CHX
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date January 2019
Est. completion date January 2020

Study information

Verified date December 2018
Source Cairo University
Contact Engy MM Kassem, Master's degree
Phone 00201000687726
Email engy.mostafa@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study is conducted to evaluate the effect of Guava leaves extract mouth wash on anti-bacterial activity against streptococcus mutans, salivary pH and patient satisfaction to taste compared to Chlorhexidine mouth wash.

P: Population with high caries risk patients I: Intervention by Guava leaves extract mouthwash C: Control is Chlorhexidine mouthwash O1: The primary outcome is antibacterial activity. O2: The secondary outcome is salivary pH O3: The tertiary outcome is patient satisfaction to taste


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 94
Est. completion date January 2020
Est. primary completion date November 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria

1. High caries risk patients

2. 18-50 years

3. Healthy cooperative patients

4. Males or Females

Exclusion Criteria

1. Medically compromised patients

2. Patients with any systemic disease that might affect the salivary flow

3. Allergy to any of the ingredients

4. Patients with physical limitations that might affect normal tooth brushing and mouth rinsing

5. Presence of intraoral infections

6. Currently using any mouth rinse

7. Smokers

8. Use of antibiotics in the previous 30 days

Study Design


Intervention

Drug:
Guava leaves extract
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 •
Chlorhexidine
chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Patient satisfaction to taste: questionnaire The patient will fill a questionnaire to assess patient satisfaction to taste after usage of the mouthwash. Nominal answers 3 months
Primary 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 Salivary pH Saliva samples pH will be measured using digital pH meter to evaluate its efficacy in preventing the action of acidogenic bacteria in high caries risk patients.
It displays numerical value.
3 months
See also
  Status Clinical Trial Phase
Completed NCT04566120 - Streptococcus Mutans Cariogenicity by Real-time PCR in High Caries Risk Patients N/A
Completed NCT05744622 - Clinical Evaluation of Chemically Cured Conventional Glass Ionomer After Light Emitting Diode Radiant Heat Enhancement N/A
Recruiting NCT04254835 - Assessment of Inhibition of Biofilm Formation and Plaque Bacterial Count of Fluoride Varnish Containing Chlorhexidine and Cetylpyridinium Chloride Versus Conventional Fluoride Varnish Phase 4
Completed NCT03684993 - Caries Prevention and Side Effects of Gum Arabic and Licorice Extracts Versus Chlorhexidine in High Caries Risk Patients Phase 2/Phase 3