Effects of Three Different Mouth Rinses on Dental Plaque in Children

NCT ID: NCT06013735

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2021-06-22

Brief Summary

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.

Conditions

Gingival Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

sodium fluoride solution

children will rinse with sodium fluoride solution mouth rinse (0.2%).

Group Type: ACTIVE_COMPARATOR

sodium fluoride solution

Intervention Type: DRUG

sodium fluoride solution mouth rinse (0.2%).

guava leaves

children will rinse with guava leaves aqueous extract mouth rinse (0.5%).

Group Type: ACTIVE_COMPARATOR

guava leaves aqueous extract

Intervention Type: DRUG

guava leaves aqueous extract mouth rinse (0.5%)

pomegranate peel

children will rinse with pomegranate peel aqueous extract mouth rinse (0.5%).

Group Type: ACTIVE_COMPARATOR

pomegranate peel aqueous extrac

Intervention Type: DRUG

pomegranate peel aqueous extract mouth rinse (0.5%).

Control

children will rinse with distilled water

Group Type: PLACEBO_COMPARATOR

Distilled water

Intervention Type: OTHER

placebo distilled water

Interventions

sodium fluoride solution

sodium fluoride solution mouth rinse (0.2%).

Intervention Type: DRUG

guava leaves aqueous extract

guava leaves aqueous extract mouth rinse (0.5%)

Intervention Type: DRUG

pomegranate peel aqueous extrac

pomegranate peel aqueous extract mouth rinse (0.5%).

Intervention Type: DRUG

Distilled water

placebo distilled water

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

faculty of dentistry Suez canal university

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

241/2019

Identifier Type: -

Identifier Source: org_study_id