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Status unknownNCT05803590Updated Apr 7, 2023

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

An interventional study of Green tea mouthwash and Chlorhexidine mouthwash in Plaque Induced Gingivitis, sponsored by Cairo University. Status unknown. Open to participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-07.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
10 Years to 14 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Plaque Induced Gingivitis

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Keywords

  • green tea
03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's planned enrollment of 80 is above the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 14 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • 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 · Drug: Chlorhexidine mouthwash

  • 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 · Drug: Chlorhexidine mouthwash

Interventions

  • DrugGreen tea mouthwash

    effictive against caries and periodontal diseases

  • DrugChlorhexidine mouthwash

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

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What researchers measure

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.

    Time frame: one hour

Secondary outcomes

  1. 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. 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.

    Time frame: one hour

Other outcomes

  1. 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.

    Time frame: one hour

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05803590
Lead sponsor
Cairo University
Responsible party
Aya Abd Elnaser Yehia Fatoh (The Principal Investigator, Cairo University) — Principal investigator
First posted
Apr 7, 2023
Start date
May 1, 2023 (estimated)
Primary completion
Jul 1, 2023 (estimated)
Completion
Aug 1, 2023 (estimated)
Last update
Apr 7, 2023

Study contacts

Aya A. Yehia, master
Contact
aya.abdelnaser@dentistry.cu.edu.eg
01062810438 ext. +2
Marwa A. Aly, PhD
Contact
0 100 623 1612 ext. +2

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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