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

NCT ID: NCT03773094

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Guava leaves extract

A natural product that is prepared as a mouthwash

Group Type EXPERIMENTAL

Guava leaves extract

Intervention Type DRUG

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 Chlorhexidine as a mouthwash

Group Type ACTIVE_COMPARATOR

Chlorhexidine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Chlorhexidine

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

Intervention Type DRUG

Other Intervention Names

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Psidium guajava Chlorhexidine glucnate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Engy Mostafa Magdy Abdou Ahmed Kassem

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Engy MM Kassem, Master's degree

Role: CONTACT

Phone: 00201000687726

Email: [email protected]

Mohamed A Khairy, PhD

Role: CONTACT

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 26130940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25125881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29087796 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30166841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27681394 (View on PubMed)

Other Identifiers

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Guava leaves extract CHX

Identifier Type: -

Identifier Source: org_study_id