Compare the Effect of Green Tea Mouthwash vs Chlorohexidine Mouthwash in Children With Plaque-induced Gingivitis

NCT ID: NCT05803590

Last Updated: 2023-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-08-01

Brief Summary

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This study aims to assess and compare the effect of green tea mouthwash compared to chlorohexidine mouthwash in reducing gingivitis and plaque scores (in terms of plaque index and gingival index) in children with plaque-induced gingivitis.

Detailed Description

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This study aims to assess and compare the effect of green tea mouthwash compared to chlorohexidine mouthwash in reducing gingivitis and plaque scores (in terms of plaque index and gingival index) in children with plaque-induced gingivitis.

This study will be conducted in the outpatient clinics of the Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University - Egypt.

Patients attending the outpatient clinic in Pediatric Dentistry and Dental Public health Department - Faculty of Dentistry - Cairo University - Egypt will be screened until the target population is achieved.

Conditions

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Plaque Induced Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinding of the operator and the patients will not be applicable due to the difference between the used mouthwashes. However, the statistician will be blinded.

Study Groups

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Green Tea Mouthwash ( intervention )

Green tea (GT), obtained from the extracts of a small plant, Camelia sinesis, is common worldwide. It is rich in flavonoids such as catechins and various other polyphenols, contributing to its antioxidant and anti-inflammatory properties. Green tea consumption is also associated with lower incidences of diabetes, cardiovascular disease, and obesity. Moreover, its antibacterial property aids in the reduction of bacterial colonization and thereby prevents oral diseases such as gingivitis, periodontal diseases, dental caries, and malodor .

When used as a mouthwash, green tea preparations can obliterate bad breath by suppressing anaerobic bacteria and eradicating the production of volatile sulfur compounds. There is a lack of critically appraised summaries on the efficacy of green tea mouthwash for promoting dental hygiene .

Group Type ACTIVE_COMPARATOR

Green tea mouthwash

Intervention Type DRUG

effictive against caries and periodontal diseases

Chlorhexidine mouthwash

Intervention Type DRUG

the gold standard against which other anti-plaque and gingivitis agents are measured

Chlorhexidine Mouthwash ( control )

Chlorhexidine was developed in 1950 and is the most used anti-plaque agent. However, the long-term usage of chlorhexidine (CHX) is limited by altered taste perception and tooth staining with prolonged usage. Though CHX has been the gold standard mouthwash in controlling plaque formation, its undesirable side effects, such as the enhanced ability of calculus formation, bitter taste, and interference with taste, have inspired a search for alternatives

Group Type EXPERIMENTAL

Green tea mouthwash

Intervention Type DRUG

effictive against caries and periodontal diseases

Chlorhexidine mouthwash

Intervention Type DRUG

the gold standard against which other anti-plaque and gingivitis agents are measured

Interventions

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Green tea mouthwash

effictive against caries and periodontal diseases

Intervention Type DRUG

Chlorhexidine mouthwash

the gold standard against which other anti-plaque and gingivitis agents are measured

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children aged 10-14 years.
* Children with a gingival index score of ≥ 1 and a plaque index score of ≥ 1.
* Children in good medical health and free from major oral hard or soft tissue lesions. \[Medically fit children (ASA I, II)\].
* Children classified as cooperative or potentially cooperative according to Wright's classification of child behavior.
* Children mentally capable of communication.

Exclusion Criteria

* Parental refusal for participation.
* Children under antibiotics treatment during the last six weeks prior to the study.
* Children wearing fixed or removable orthodontic devices.
* Patients who underwent oral prophylaxis in the last six months.
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Aya Abd Elnaser Yehia Fatoh

The Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Aya A. Yehia, master

Role: CONTACT

01062810438 ext. +2

Marwa A. Aly, PhD

Role: CONTACT

0 100 623 1612 ext. +2

Other Identifiers

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GT Mouthwash In Children

Identifier Type: -

Identifier Source: org_study_id

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