Taste Acceptance and Effectiveness of Hyaluronic Acid and Chlorhexidine Mouthwashes in Children With Gingivitis
Taste Acceptance and Clinical Effectiveness of Hyaluronic Acid Versus Chlorhexidine Mouthwashes in Children With Plaque-Induced Gingivitis: A Randomized Controlled Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Yasmeen AS Abdelqader, Bachelors
- Numero di telefono: +201018727929
- Email: Yasmeen.saleh@dentistry.cu.edu.eg
Luoghi di studio
-
-
Egypt
-
Cairo, Egypt, Egitto, 11411
- Faculty of Dentistry, Cairo University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Hyaluronic acid mouthwah
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
|
Q-Afta®, CIRA Pharma, Egypt
|
|
Comparatore attivo: Chlorohexidine mouthwash
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.
|
Hexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Taste acceptance
Lasso di tempo: 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
|
After 14 days of mouthwash administeration
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Gingival index
Lasso di tempo: At baseline before the study and after 14 days
|
Gingival health will be measured by Löe & Silness gingival index
|
At baseline before the study and after 14 days
|
|
Plaque index
Lasso di tempo: At baseline before the study and after 14 days
|
Plaque index will be measured by Löe & Silness plaque index
|
At baseline before the study and after 14 days
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Ola M Omar, Professor, Cairo University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Mouthwashes for children-2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .