Skip to main content
Clinical Trials/NCT06013735
NCT06013735CompletedNot 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 enrollmentStarted: February 17, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Gingival health

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Active Comparator

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

Intervention: sodium fluoride solution (Drug)

guava leaves

Active Comparator

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

Intervention: guava leaves aqueous extract (Drug)

pomegranate peel

Active Comparator

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

Intervention: pomegranate peel aqueous extrac (Drug)

Control

Placebo Comparator

children will rinse with distilled water

Intervention: Distilled water (Other)

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials