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Effects of Three Different Mouth Rinses on Dental Plaque in Children

Primary Purpose

Gingival Diseases

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sodium fluoride solution
guava leaves aqueous extract
pomegranate peel aqueous extrac
Distilled water
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingival Diseases

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • faculty of dentistry Suez canal university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

sodium fluoride solution

guava leaves

pomegranate peel

Control

Arm Description

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

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

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

children will rinse with distilled water

Outcomes

Primary Outcome Measures

Gingival health
gingival index score from 0 to 3, where 0 normal gingiva and 3 severe inflammation
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
streptococcus mutans and lactobacilli count
calculate the counts of streptococcus mutans and lactobacilli

Secondary Outcome Measures

Full Information

First Posted
July 8, 2023
Last Updated
August 24, 2023
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT06013735
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suez Canal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sodium fluoride solution
Arm Type
Active Comparator
Arm Description
children will rinse with sodium fluoride solution mouth rinse (0.2%).
Arm Title
guava leaves
Arm Type
Active Comparator
Arm Description
children will rinse with guava leaves aqueous extract mouth rinse (0.5%).
Arm Title
pomegranate peel
Arm Type
Active Comparator
Arm Description
children will rinse with pomegranate peel aqueous extract mouth rinse (0.5%).
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
children will rinse with distilled water
Intervention Type
Drug
Intervention Name(s)
sodium fluoride solution
Intervention Description
sodium fluoride solution mouth rinse (0.2%).
Intervention Type
Drug
Intervention Name(s)
guava leaves aqueous extract
Intervention Description
guava leaves aqueous extract mouth rinse (0.5%)
Intervention Type
Drug
Intervention Name(s)
pomegranate peel aqueous extrac
Intervention Description
pomegranate peel aqueous extract mouth rinse (0.5%).
Intervention Type
Other
Intervention Name(s)
Distilled water
Intervention Description
placebo distilled water
Primary Outcome Measure Information:
Title
Gingival health
Description
gingival index score from 0 to 3, where 0 normal gingiva and 3 severe inflammation
Time Frame
baseline , after 7 days and after 15 days
Title
plaque accumulation and pocket depth
Description
plaque index score from 0 to 3, where 0 no plaque and 3 abundance of soft matter within gingival pocket
Time Frame
baseline , after 7 days and after 15 days
Title
streptococcus mutans and lactobacilli count
Description
calculate the counts of streptococcus mutans and lactobacilli
Time Frame
baseline , after 7 days and after 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
faculty of dentistry Suez canal university
City
Ismailia
Country
Egypt

12. IPD Sharing Statement

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Effects of Three Different Mouth Rinses on Dental Plaque in Children

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