Clinical trial NCT06013735: Effects of Three Different Mouth Rinses on Dental Plaque in Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Diseases
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Gingival health
timeFrame: baseline , after 7 days and after 15 days
measure: plaque accumulation and pocket depth
timeFrame: baseline , after 7 days and after 15 days
measure: streptococcus mutans and lactobacilli count
timeFrame: baseline , after 7 days and after 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: faculty of dentistry Suez canal university
Study officials:
References: