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

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03773094
• Collaborator: (none)
• Enrollment: 94
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
High Caries Risk Patients; Antimicrobial Effect; Salivary pH; Patient Satisfaction to Taste	Drug: Guava leaves extract; Drug: Chlorhexidine	Phase 2/Phase 3

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Anticipated Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Nov 1, 2019
• Anticipated Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guava leaves extract A natural product that is prepared as a mouthwash	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 •; Other Names: Psidium guajava
Active Comparator: Chlorhexidine chemical agent Chlorhexidine as a mouthwash	Drug: Chlorhexidine; chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard; Other Names: Chlorhexidine glucnate

Outcome Measures

Primary Outcome Measures

1. Anti-bacterial effect against streptococcus mutans [3 months]

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

Secondary Outcome Measures

1. Salivary pH [3 months]

   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.

Other Outcome Measures

1. Patient satisfaction to taste: questionnaire [3 months]

   The patient will fill a questionnaire to assess patient satisfaction to taste after usage of the mouthwash. Nominal answers

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Engy Mostafa Magdy Abdou Ahmed Kassem, Assistant Lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT03773094
• Other Study ID Numbers: Guava leaves extract CHX
• First Posted: Dec 12, 2018
• Last Update Posted: Dec 12, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chlorhexidine; Chlorhexidine gluconate

Study Results

No Results Posted as of Dec 12, 2018