Skip to main content
Clinical Trials/NCT06013735
NCT06013735
Completed
Not Applicable

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

Suez Canal University1 site in 1 country40 target enrollmentFebruary 17, 2020

Overview

Phase
Not Applicable
Intervention
sodium fluoride solution
Conditions
Gingival Diseases
Sponsor
Suez Canal University
Enrollment
40
Locations
1
Primary Endpoint
Gingival health
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 17, 2020
End Date
June 22, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Uncooperative children.
  • Children with history of allergy to dental products or their products
  • Parents refusal.

Arms & Interventions

sodium fluoride solution

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

Intervention: sodium fluoride solution

guava leaves

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

Intervention: guava leaves aqueous extract

pomegranate peel

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

Intervention: pomegranate peel aqueous extrac

Control

children will rinse with distilled water

Intervention: Distilled water

Outcomes

Primary Outcomes

Gingival health

Time Frame: baseline , after 7 days and after 15 days

gingival index score from 0 to 3, where 0 normal gingiva and 3 severe inflammation

plaque accumulation and pocket depth

Time Frame: baseline , after 7 days and after 15 days

plaque index score from 0 to 3, where 0 no plaque and 3 abundance of soft matter within gingival pocket

streptococcus mutans and lactobacilli count

Time Frame: baseline , after 7 days and after 15 days

calculate the counts of streptococcus mutans and lactobacilli

Study Sites (1)

Loading locations...

Similar Trials