Efficacy and Safety of HA35 Gel for Mild Gingival Recession and Periodontal Inflammation (HA35-PERI)
A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Mild Gingival Recession and Chronic Periodontal Inflammation
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for improving mild gingival recession (Miller Class I/II) and chronic periodontal inflammatory symptoms including gingival pain, redness, swelling, and brushing-induced bleeding.
Eligible subjects will perform routine tooth brushing followed by gentle topical application of HA35 gel to the gingival margin, teeth, and affected gingival areas for approximately 3 minutes, twice daily (morning and evening) for 42 consecutive days.
Outcome assessments include measurement of exposed root surface length (gingival recession), chronic gingival/radicular pain (NRS 0-10), gingival itching/discomfort, redness and swelling scores, and incidence of brushing-induced bleeding at baseline, 30 seconds after first application, Day 2, Day 4, and Day 42.
Oral irritation, allergic reactions, and adverse events will be monitored continuously 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
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age 18-60 years, male or female
- Clinically diagnosed with mild gingival recession (Miller Class I or II)
- Chronic gingival pain, redness, swelling, or brushing-induced bleeding
- Ability to complete self-assessments and comply with 42-day intervention
- Signed written informed consent
Exclusion Criteria:
- Severe periodontitis, tooth mobility, or alveolar bone loss
- Uncontrolled diabetes or immune dysfunction
- Use of prescription periodontal medications within 2 weeks
- Known hypersensitivity to hyaluronan or gel components
- Oral infection, ulceration, or severe mucosal injury
- 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 Topical Gingival Gel Group
Participants apply 10% high-concentration 35 kDa HA35 gel topically to the gingival and tooth surfaces twice daily for 42 consecutive days.
Efficacy on gingival recession, periodontal inflammation, pain, bleeding, and safety will be evaluated.
|
Topical oral gel containing 10% high-concentration 35 kDa hyaluronan fragment.
Applied topically to gingival and tooth surfaces to improve mild gingival recession, reduce periodontal inflammation, relieve gingival pain, and decrease brushing-induced bleeding.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Gingival Recession Depth (mm)
Délai: Baseline to Day 42
|
Change in gingival recession depth, measured in millimeters (mm) using a calibrated periodontal probe.
Baseline measurement is the distance from the cementoenamel junction (CEJ) to the gingival margin.
|
Baseline to Day 42
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Chronic Gingival/Radicular Pain Intensity (0-10 NRS)
Délai: Baseline to Day 42
|
Change in chronic gingival or radicular pain intensity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain.
|
Baseline to Day 42
|
|
Change in Gingival Itching/Discomfort Intensity (0-10 NRS)
Délai: Baseline to 30 seconds after first application
|
Change in gingival itching or discomfort intensity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no discomfort and 10 = maximum discomfort.
|
Baseline to 30 seconds after first application
|
|
Change in Gingival Redness and Swelling Severity (0-10 Scale)
Délai: Baseline to Day 4
|
Change in gingival redness and swelling severity, assessed using a 0-10 ordinal scale, where 0 = normal gingiva and 10 = severe redness and swelling.
|
Baseline to Day 4
|
|
Resolution Rate of Brushing-Induced Gingival Bleeding
Délai: Baseline to Day 2
|
Proportion of participants with complete resolution of brushing-induced gingival bleeding, defined as no bleeding observed during gentle tooth brushing.
|
Baseline to Day 2
|
|
Incidence and Severity of Oral Adverse Events
Délai: Throughout the 42-day treatment period
|
Number and severity of treatment-related oral adverse events, including irritation, ulceration, or allergic reactions, assessed by clinical observation and participant report.
Severity graded using the Common Terminology Criteria for Adverse Events (CTCAE).
|
Throughout the 42-day treatment period
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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
- HA35202607
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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