Antibacterial Effect of Guava Leaves Extract Mouthwash Compared to Chlorhexidine Mouthwash in High Caries Risk Patients

High Caries Risk Patients Clinical Trial

Official title:

Effect of Guava Leaves Extract Mouth Wash on Antibacterial Activity, Salivary pH and Patient Satisfaction Compared to Chlorhexidine Mouth Wash in High Caries Risk Patients: A Randomized Control Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03773094
• Other study ID #: Guava leaves extract CHX
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Antimicrobial Effect
• High Caries Risk Patients
• Patient Satisfaction to Taste
• Salivary pH

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