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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05803590

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Plaque Induced Gingivitis	Drug: Green tea mouthwash Drug: Chlorhexidine mouthwash	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 effictive against caries and periodontal diseases Drug: Chlorhexidine mouthwash the gold standard against which other anti-plaque and gingivitis agents are measured
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 effictive against caries and periodontal diseases Drug: Chlorhexidine mouthwash the gold standard against which other anti-plaque and gingivitis agents are measured

Arm

Intervention/Treatment

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

effictive against caries and periodontal diseases

Drug: Chlorhexidine mouthwash

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

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

effictive against caries and periodontal diseases

Drug: Chlorhexidine mouthwash

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

Outcome Measures

Primary Outcome Measures

Gingivitis will be recorded by the Gingival index [one hour]
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 [one hour]
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.

Other Outcome Measures

Patient Satisfaction using a questionnaire [one hour]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 14 Years

Sexes Eligible for Study:

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:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aya Abd Elnaser Yehia Fatoh, The Principal Investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05803590

Other Study ID Numbers:

GT Mouthwash In Children

First Posted:

Apr 7, 2023

Last Update Posted:

Apr 7, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aya Abd Elnaser Yehia Fatoh, The Principal Investigator, Cairo University

green tea

Additional relevant MeSH terms:

Gingivitis

Chlorhexidine

Study Results

No Results Posted as of Apr 7, 2023