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

Plaque Induced Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05803590
• Other study ID #: GT Mouthwash In Children
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: Aya A. Yehia, master
• Phone: 01062810438
• Email: aya.abdelnaser[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis
• Plaque Induced Gingivitis

Intervention

Drug:
• Green tea mouthwash
effictive against caries and periodontal diseases
• Chlorhexidine mouthwash
the gold standard against which other anti-plaque and gingivitis agents are measured

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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