Effects of Three Different Mouth Rinses on Dental Plaque in Children

NCT06013735 | Completed

• 1 other identifier: 241/2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Diseases

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• streptococcus mutans and lactobacilli count

  calculate the counts of streptococcus mutans and lactobacilli

  baseline , after 7 days and after 15 days

Study Arms (4)

sodium fluoride solution

ACTIVE COMPARATOR

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

Drug: sodium fluoride solution

guava leaves

ACTIVE COMPARATOR

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

Drug: guava leaves aqueous extract

pomegranate peel

ACTIVE COMPARATOR

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

Drug: pomegranate peel aqueous extrac

Control

PLACEBO COMPARATOR

children will rinse with distilled water

Other: Distilled water

Interventions

sodium fluoride solution DRUG

sodium fluoride solution mouth rinse (0.2%).

sodium fluoride solution

guava leaves aqueous extract DRUG

guava leaves aqueous extract mouth rinse (0.5%)

guava leaves

pomegranate peel aqueous extrac DRUG

pomegranate peel aqueous extract mouth rinse (0.5%).

pomegranate peel

Distilled water OTHER

placebo distilled water

Control

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

faculty of dentistry Suez canal university

Ismailia, Egypt

Location

MeSH Terms

Conditions

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2023
• First Posted: August 28, 2023
• Study Start: February 17, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 22, 2021
• Last Updated: August 28, 2023

Record last verified: 2021-09

Locations

EG (1)