Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized controlled clinical trial aims to compare the taste acceptance and clinical effectiveness of hyaluronic mouthwash and chlorhexidine mouthwash in children with plaque-induced gingivitis. Clinical outcomes will be assessed using gingival and plaque indices, while taste acceptance will be evaluated using a validated hedonic scale. The findings may help identify a mouthwash that is both effective and acceptable to children, thereby improving adherence to oral hygiene practices.
This study is a randomized, single-blind, controlled clinical trial designed to compare the taste acceptance and clinical effectiveness of a hyaluronic acid mouthwash and a chlorhexidine mouthwash in children aged 8 to 10 years with plaque-induced gingivitis.
Eligible participants will be recruited from the outpatient clinic and screened according to the study eligibility criteria. After obtaining informed consent from parents or legal guardians and assent from the children, baseline clinical assessments will be performed. Gingival inflammation will be evaluated using the Loe and Silness Gingival Index, and dental plaque accumulation will be assessed using the Silness and Loe Plaque Index.
Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The intervention group will receive a hyaluronic acid mouthwash, while the control group will receive a chlorhexidine mouthwash. Allocation concealment will be maintained using sealed opaque envelopes prepared by an independent investigator. Clinical outcome assessment will be performed by a blinded examiner who will remain unaware of group allocation throughout the study period.
All participants will receive standardized oral hygiene instructions and identical instructions regarding mouthwash use. Participants will be instructed to use the assigned mouthwash twice daily for 14 days in addition to their routine toothbrushing practices.
Taste acceptance will be evaluated as the primary outcome using a validated facial hedonic scale following mouthwash use. Secondary outcomes will include changes in gingival inflammation and plaque accumulation, as measured by the Loe and Silness Gingival Index and the Silness and Loe Plaque Index, respectively.
Follow-up clinical examinations will be conducted after 14 days of intervention. Compliance with mouthwash use and any adverse events will be documented throughout the study period. The study aims to determine whether hyaluronic acid mouthwash provides comparable clinical effectiveness to chlorhexidine while demonstrating greater taste acceptance among children with plaque-induced gingivitis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid mouthwah | Experimental | Participants in the experimental group will use a hyaluronic acid mouthwash (Q-Afta®, CIRA Pharma, Egypt). The principle investigator will instruct each participant to rinse with 10 mL of the mouthwash for 30-60 seconds twice daily after toothbrushing for a period of 14 days. And also not to swallow the mouthwash and to avoid eating or drinking for 30 minutes after rinsing |
|
| Chlorohexidine mouthwash | Active Comparator | Participants in the control group will use a chlorohexidine mouthwash (Hexitol). The principle investigator will instruct each participant to rinse with 10 mL of the mouthwash for 30-60 seconds twice daily after toothbrushing for a period of 14 day and not to swallow the mouthwash and to avoid eating or drinking for 30 minutes after rinsing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid mouthwash | Drug | Q-Afta®, CIRA Pharma, Egypt |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Taste acceptance | Taste acceptance will be assessed using a visual analog scale (VAS) of faces, rated from 1 to 5, where 1 represents very bad taste, and 5 represents very good taste | After 14 days of mouthwash administeration |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival index | Gingival health will be measured by Löe & Silness gingival index | At baseline before the study and after 14 days |
| Plaque index | Plaque index will be measured by Löe & Silness plaque index |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasmeen AS Abdelqader, Bachelors | Contact | +201018727929 | Yasmeen.saleh@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ola M Omar, Professor | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry, Cairo university | Cairo | Egypt | 11411 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009067 | Mouthwashes |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
Not provided
Not provided
Not provided
Not provided
Not provided
Blinding of trial's principal investigator will not be possible due to evident differences between the two mouthwashes.
The statistician responsible for data analysis will remain blinded to group allocation.
| Chlorohexidine 0.12% mouthwash |
| Drug |
Hexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company |
|
| At baseline before the study and after 14 days |
| D009057 |
| Stomatognathic Diseases |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |