Effects of Three Different Mouth Rinses on Dental Plaque in Children

Clinical and Microbiological Effects of Three Different Mouth Rinses Made of Sodium Fluoride, Guava Leaves Extract or Pomegranate Peel Extract on Dental Plaque in Children

Dental plaque is a major problem in the field of oral and dental health and its prevention is more important to avoid dental caries and gingival diseases. Mouth washes are very useful in the reduction of microbial plaque and gingival inflammation. Sodium fluoride mouth wash is one of the ways that prevent dental plaque. Recently, using herbal products are efficient in decreasing dental plaque. Pomegranate peels and Guava leaves extracts are an essential medicinal plant with various pharmacological properties.

Aim of study: To evaluate and compare the efficiency of different mouth rinses (sodium fluoride mouth rinse, guava leaves aqueous extract and pomegranate aqueous extract) on dental plaque in children, clinically by measuring gingival and plaque indices scores and microbiologically by measuring of streptococcus mutans and lactobacillus.

Materials and methods: forty apparently healthy and cooperative children were selected from the Outpatient Dental Clinic of Pediatric dentistry Department, Faculty of Dentistry, Suez Canal University. Children were randomly divided into three groups as follows:

Group (I):10 children will rinse with sodium fluoride, Group (II): 10 children will rinse with guava leaves aqueous extract and Group (III):10 children will rinse with pomegranate peels aqueous extract. Group (IV):10 children will rinse with water (control group). Instructions for oral hygiene and using mouth wash will be demonstrated for every child. Clinical and microbiological examinations will be done firstly at day one before using any type of examined mouthwashes (0-base line), then clinical and microbiological follow up will be done after 7 and 15 days of using different mouthwash for each group.

Study Overview

• Status: Completed
• Conditions: Gingival Diseases
• Intervention / Treatment: Drug: sodium fluoride solution; Drug: guava leaves aqueous extract; Drug: pomegranate peel aqueous extrac; Other: Distilled water

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Faculty of Dentistry Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children are apparently healthy.
2. Their age's ranges from 6-12 years {mixed dentition}, First permanent molars were fully erupted.
3. Children are not taking antibiotics, steroids and inflammatory therapy for two weeks before study or during this study.
4. Children are caries free at time of the study.
5. Children with no regular use of chewing xylitol gum.
6. Children without orthodontic appliance.
7. Children are not using fluoride tooth paste or any topical fluoride application at time of study.
8. Children who have dental plaque.

Exclusion Criteria:

1. Uncooperative children.
2. Children with history of allergy to dental products or their products
3. Parents refusal.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sodium fluoride solution; children will rinse with sodium fluoride solution mouth rinse (0.2%).	Drug: sodium fluoride solution; sodium fluoride solution mouth rinse (0.2%).
Active Comparator: guava leaves; children will rinse with guava leaves aqueous extract mouth rinse (0.5%).	Drug: guava leaves aqueous extract; guava leaves aqueous extract mouth rinse (0.5%)
Active Comparator: pomegranate peel; children will rinse with pomegranate peel aqueous extract mouth rinse (0.5%).	Drug: pomegranate peel aqueous extrac; pomegranate peel aqueous extract mouth rinse (0.5%).
Placebo Comparator: Control; children will rinse with distilled water	Other: Distilled water; placebo distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival health	gingival index score from 0 to 3, where 0 normal gingiva and 3 severe inflammation	baseline , after 7 days and after 15 days
plaque accumulation and pocket depth	plaque index score from 0 to 3, where 0 no plaque and 3 abundance of soft matter within gingival pocket	baseline , after 7 days and after 15 days
streptococcus mutans and lactobacilli count	calculate the counts of streptococcus mutans and lactobacilli	baseline , after 7 days and after 15 days

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 22, 2021

Study Registration Dates

• First Submitted: July 8, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Dental Deposits; Dental Plaque; Gingival Diseases; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: 241/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No