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NCT Number: NCT06013735

Effects of Three Different Mouth Rinses on Dental Plaque in Children

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry Suez canal university

Ismailia, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sodium fluoride solution

Drug

sodium fluoride solution mouth rinse (0.2%).

guava leaves aqueous extract

Drug

guava leaves aqueous extract mouth rinse (0.5%)

pomegranate peel aqueous extrac

Drug

pomegranate peel aqueous extract mouth rinse (0.5%).

Distilled water

Other

placebo distilled water

Primary outcomes

  1. 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

  2. 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

  3. streptococcus mutans and lactobacilli count

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

    calculate the counts of streptococcus mutans and lactobacilli

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2023
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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