Effects of Three Different Mouth Rinses on Dental Plaque in Children

Gingival Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06013735
• Other study ID #: 241/2019
• Status: Completed
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: June 22, 2021

Study information

• Verified date: September 2021
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 22, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque
• Gingival Diseases

Intervention

Drug:
• sodium fluoride solution
sodium fluoride solution mouth rinse (0.2%).
• guava leaves aqueous extract
guava leaves aqueous extract mouth rinse (0.5%)
• pomegranate peel aqueous extrac
pomegranate peel aqueous extract mouth rinse (0.5%).

Other:
• Distilled water
placebo distilled water

Locations

Country	Name	City	State
Egypt	faculty of dentistry Suez canal university	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	streptococcus mutans and lactobacilli count	calculate the counts of streptococcus mutans and lactobacilli	baseline , after 7 days and after 15 days