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

Comparative Effect of Green Tea Versus Chlorhexidine Mouthwash on Plaque Induced Gingivitis In a Group of Egyptian Children: Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Plaque Induced Gingivitis
• Intervention / Treatment: Drug: Green tea mouthwash; Drug: Chlorhexidine mouthwash

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aya A. Yehia, master; Phone Number: +2 01062810438; Email: aya.abdelnaser@dentistry.cu.edu.eg
• Study Contact Backup: Name: Marwa A. Aly, PhD; Phone Number: +2 0 100 623 1612

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 .	Drug: Green tea mouthwash; effictive against caries and periodontal diseases; Drug: Chlorhexidine mouthwash; the gold standard against which other anti-plaque and gingivitis agents are measured
Experimental: 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	Drug: Green tea mouthwash; effictive against caries and periodontal diseases; Drug: Chlorhexidine mouthwash; the gold standard against which other anti-plaque and gingivitis agents are measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingivitis will be recorded by the Gingival index	Gingival Index (GI): (Loe and Sillness Index) records qualitative changes in the gingiva. It scores the marginal and interproximal tissues separately based on 0 to 3. The criteria are: 0= Normal gingiva. 1= Mild inflammation - a slight change in color and slight edema but no bleeding on probing. 2= Moderate inflammation - redness, edema, and glazing, bleeding on probing. 3= Severe inflammation - marked redness and edema, ulceration with the tendency to spontaneous bleeding. The bleeding is assessed by gently probing along the wall of the soft tissue of the gingival sulcus. The scores of the four areas of the tooth can be summed and divided by four to give the GI for the tooth. The GI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The Gingival Index may be scored for all surfaces or selected teeth or for selected areas of all teeth.	one hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of dental plaque will be recorded by the Plaque index	Plaque Index (PI): (Sillness and Loe Index) is an index for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin (the gingival one-third of the teeth). It can be used on all teeth or selected teeth. It is used on all four surfaces (M, B, D, L). The criteria are: 0= No plaque.; A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can not be seen with the naked eye. But only by using disclosing solution or using a probe.; Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.; Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.	one hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction using a questionnaire	The participants will be asked to fill in at the end of the observation period a questionnaire to indicate on a 0 to 3 scale (0, disagree; 1 slightly disagree; 2, slightly agree; 3, agree) his/her level of agreement to nine statements concerning the mouthwashes under investigation regarding safety, tolerability, pleasantness, and performance.	one hour

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: green tea
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: GT Mouthwash In Children

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No