Back to resultsCompare the Effect of Green Tea Mouthwash vs Chlorohexidine Mouthwash in Children With Plaque-induced Gingivitis
Primary Purpose
Plaque Induced Gingivitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Green tea mouthwash
Chlorhexidine mouthwash
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Induced Gingivitis focused on measuring green tea
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Green Tea Mouthwash ( intervention )
Chlorhexidine Mouthwash ( control )
Arm Description
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 .
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05803590
Brief Title
Compare the Effect of Green Tea Mouthwash vs Chlorohexidine Mouthwash in Children With Plaque-induced Gingivitis
Official Title
Comparative Effect of Green Tea Versus Chlorhexidine Mouthwash on Plaque Induced Gingivitis In a Group of Egyptian Children: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Induced Gingivitis
Keywords
green tea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Green Tea Mouthwash ( intervention )
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
Chlorhexidine Mouthwash ( control )
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Green tea mouthwash
Intervention Description
effictive against caries and periodontal diseases
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Intervention Description
the gold standard against which other anti-plaque and gingivitis agents are measured
Primary Outcome Measure Information:
Title
Gingivitis will be recorded by the Gingival index
Description
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 Outcome Measure Information:
Title
Presence of dental plaque will be recorded by the Plaque index
Description
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.
Time Frame
one hour
Other Pre-specified Outcome Measures:
Title
Patient Satisfaction using a questionnaire
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aya A. Yehia, master
Phone
01062810438
Ext
+2
Email
aya.abdelnaser@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa A. Aly, PhD
Phone
0 100 623 1612
Ext
+2
12. IPD Sharing Statement
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Compare the Effect of Green Tea Mouthwash vs Chlorohexidine Mouthwash in Children With Plaque-induced Gingivitis
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