Plaque Induced Gingival Disease
Conditions
Keywords
gingivitis, Chlorohexidine, Hyaluronic acid, Mouthwashe, Children, Taste acceptance, Palatability
Brief summary
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.
Detailed description
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.
Interventions
Q-Afta®, CIRA Pharma, Egypt
Hexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged from 8-12 years of both sexes. * Children with a history of bleeding on brushing typical signs and symptoms of gingivitis. * Healthy child (ASA I). * Eruption of upper and lower permanent central and lateral incisors. * Parent's agreement to sign the informed consent. * Parent's ability for attending follow up visits.
Exclusion criteria
* Children -allergic to Chlorhexidine or Hyaluronic acid. * Children with special health care needs or having a history of serious systemic disease that may affect the gingival health. * Use of Systemic NSAIDs, steroids, or antibiotics within a month before the study. * Children undergoing orthodontic treatment or having an intra-oral prosthesis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Taste acceptance | After 14 days of mouthwash administeration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival index | At baseline before the study and after 14 days | Gingival health will be measured by Löe \& Silness gingival index |
| Plaque index | At baseline before the study and after 14 days | Plaque index will be measured by Löe \& Silness plaque index |
Countries
Egypt
Contacts
CONTACTYasmeen AS Abdelqader, Bachelors
STUDY_DIRECTOROla M Omar, Professor
Cairo University
Outcome results
None listed