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

NCT05803590 | Unknown

• 1 other identifier: GT Mouthwash In Children
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Plaque Induced Gingivitis

Keywords

green tea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Presence of dental plaque will be recorded by the Plaque index

  one hour

Other Outcomes (1)

• Patient Satisfaction using a questionnaire

  one hour

Study Arms (2)

Green Tea Mouthwash ( intervention )

ACTIVE COMPARATOR

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; Drug: Chlorhexidine mouthwash

Chlorhexidine Mouthwash ( control )

EXPERIMENTAL

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; Drug: Chlorhexidine mouthwash

Interventions

Green tea mouthwash DRUG

effictive against caries and periodontal diseases

Chlorhexidine Mouthwash ( control ); Green Tea Mouthwash ( intervention )

Chlorhexidine mouthwash DRUG

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

Chlorhexidine Mouthwash ( control ); Green Tea Mouthwash ( intervention )

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Aya A. Yehia, master

CONTACT

01062810438; aya.abdelnaser@dentistry.cu.edu.eg

Marwa A. Aly, PhD

CONTACT

0 100 623 1612

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Principal Investigator

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 7, 2023
• Study Start: May 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-03