Efficacy and Safety of HA35 Gel for Post-Dental Gingival Pain and Swelling (HA35)
A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Post-Dental Gingival Pain and Swelling
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This prospective, single-center, single-arm, open-label pilot clinical study investigates the analgesic and anti-inflammatory efficacy of 10% high-concentration 35 kDa hyaluronan (HA35) gel delivered via gel-soaked cotton balls for managing gingival pain and swelling following dental procedures (including restoration, transplantation, extraction, and scaling).
Eligible subjects will place HA35 gel-soaked sterile cotton balls on the affected gingival area, gently chew and retain the cotton balls in place for 30 minutes to allow sustained local infiltration. Pain intensity will be assessed using a 0-10 Numeric Rating Scale (NRS), and gingival swelling using a 0-10 Visual Analog Scale (VAS) at baseline, 1 minute, 30 minutes, and 60 minutes after application.
Oral irritation, allergic reactions, and adverse events will be monitored for safety assessment.
This is a non-invasive, non-pharmacological oral topical intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age 18-65 years, male or female
- Experienced gingival pain and swelling within 12 hours after dental procedures
- Baseline gingival pain NRS score ≥2
- Able to independently complete pain and swelling assessments
- Signed written informed consent
Exclusion Criteria:
- Severe periodontitis, uncontrolled diabetes, or immune dysfunction
- Long-term use of analgesics or anti-inflammatory drugs
- Known hypersensitivity to hyaluronan or gel components
- Oral infection, ulceration, or severe mucosal injury at the application site
- Pregnant or lactating women
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: HA35 Gel Topical Application Group
Participants receive 10% high-concentration 35 kDa HA35 gel delivered via gel-soaked cotton balls, which are gently chewed and held in the affected gingival area for 30 minutes to allow sustained local infiltration.
Efficacy on gingival pain, swelling, and safety will be evaluated.
|
Topical oral gel containing 10% high-concentration 35 kDa hyaluronan fragment.
Delivered via gel-soaked cotton balls that are gently chewed and retained in the mouth for sustained infiltration into the affected gingival area to relieve post-dental pain and reduce swelling.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Gingival Pain NRS Score (0-10)
Délai: Baseline to 1, 30, and 60 minutes after application
|
Change in post-dental gingival pain intensity measured by 0-10 NRS, 0 = no pain, 10 = worst imaginable pain.
|
Baseline to 1, 30, and 60 minutes after application
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Gingival Swelling Severity (0-10 VAS Score)
Délai: Baseline to 1, 30, and 60 minutes after application
|
Change in gingival swelling severity at the treatment site, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no swelling and 10 = maximum swelling.
|
Baseline to 1, 30, and 60 minutes after application
|
|
Onset Time of Gingival Pain Relief
Délai: Within 60 minutes after application
|
Time from application to the first reported reduction in gingival pain intensity of ≥2 points on a 0-10 Numeric Rating Scale (NRS).
|
Within 60 minutes after application
|
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Incidence and Severity of Oral Adverse Events
Délai: Throughout the 60-minute observation period
|
Number and severity of treatment-related oral adverse events (e.g., irritation, numbness, allergic reaction) reported during the study.
Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
|
Throughout the 60-minute observation period
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HA35202606
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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