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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05803590
Enrollment
80
Registered
2023-04-07
Start date
2023-05-01
Completion date
2023-08-01
Last updated
2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Induced Gingivitis

Keywords

green tea

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.

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.

Interventions

effictive against caries and periodontal diseases

DRUGChlorhexidine mouthwash

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Gingivitis will be recorded by the Gingival indexone hourGingival 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.

Secondary

MeasureTime frameDescription
Presence of dental plaque will be recorded by the Plaque indexone hourPlaque 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. 1. 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. 2. 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. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

Other

MeasureTime frameDescription
Patient Satisfaction using a questionnaireone hourThe 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.

Contacts

Primary ContactAya A. Yehia, master
aya.abdelnaser@dentistry.cu.edu.eg01062810438
Backup ContactMarwa A. Aly, PhD
0 100 623 1612

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026