Effects of Three Different Mouth Rinses on Dental Plaque in Children

Sponsor

Suez Canal University (Other)

Overall Status

Completed

CT.gov ID

NCT06013735

Collaborator

(none)

Enrollment

Location

Arms

16.1

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gingival Diseases	Drug: sodium fluoride solution Drug: guava leaves aqueous extract Drug: pomegranate peel aqueous extrac Other: Distilled water	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Feb 17, 2020

Actual Primary Completion Date :

Jun 15, 2021

Actual Study Completion Date :

Jun 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: sodium fluoride solution children will rinse with sodium fluoride solution mouth rinse (0.2%).	Drug: sodium fluoride solution sodium fluoride solution mouth rinse (0.2%).
Active Comparator: guava leaves children will rinse with guava leaves aqueous extract mouth rinse (0.5%).	Drug: guava leaves aqueous extract guava leaves aqueous extract mouth rinse (0.5%)
Active Comparator: pomegranate peel children will rinse with pomegranate peel aqueous extract mouth rinse (0.5%).	Drug: pomegranate peel aqueous extrac pomegranate peel aqueous extract mouth rinse (0.5%).
Placebo Comparator: Control children will rinse with distilled water	Other: Distilled water placebo distilled water

Outcome Measures

Primary Outcome Measures

Gingival health [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 [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 [baseline , after 7 days and after 15 days]
calculate the counts of streptococcus mutans and lactobacilli

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children are apparently healthy.
Their age's ranges from 6-12 years , 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of dentistry Suez canal university	Ismailia		Egypt

Sponsors and Collaborators

Suez Canal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suez Canal University

ClinicalTrials.gov Identifier:

NCT06013735

Other Study ID Numbers:

241/2019

First Posted:

Aug 28, 2023

Last Update Posted:

Aug 28, 2023

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2023