- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07712627
Hypochlorous Acid in Non-Surgical Periodontal Therapy
The Effect of Hypochlorous Acid in the Non-Surgical Treatment of Stage I and Stage II Periodontitis
Periodontitis is a chronic inflammatory disease associated with dental plaque and characterized by the progressive destruction of the tooth-supporting tissues. The principal features of periodontitis include clinical attachment loss (CAL), alveolar bone loss, periodontal pocket formation, gingival bleeding, and the subsequent loss of periodontal tissue support.
The current gold standard for the management of periodontal disease comprises oral hygiene instruction (OHI), non-surgical periodontal therapy (NSPT), periodontal surgery when indicated, and supportive periodontal therapy (SPT). In addition, various antimicrobial agents are used as adjuncts to periodontal treatment. One such agent, hypochlorous acid (HOCl), is a potent antimicrobial with high affinity against Gram-negative bacteria within the subgingival biofilm. Hypochlorous acid is commercially available in mouthwash and spray formulations, which patients may use as adjunctive therapies following periodontal treatment.
In the present project, hypochlorous acid will be applied by the clinician using a dental device during periodontal treatment in a clinical setting. Changes in both clinical and biochemical outcomes, including high-sensitivity C-reactive protein (hs-CRP), C-reactive protein (CRP), antistreptolysin O (ASO), and oncostatin M (OSM), will be recorded and compared with those obtained following conventional periodontal treatment performed using purified water.
The novelty of the proposed study lies in the first-time use of hypochlorous acid as an irrigant in place of purified water during scaling and root planing (SRP), with the aim of evaluating its effects on both clinical and biochemical parameters. This project is expected to attract the attention of researchers investigating the treatment of periodontitis and may facilitate publication in high-impact international peer-reviewed journals as well as presentation at prestigious scientific congresses. Furthermore, it will contribute to the training of qualified researchers in periodontology and support the completion of a doctoral dissertation. The findings may also provide preliminary data for future studies aimed at developing hypochlorous acid-based adjunctive therapeutic approaches for the management of periodontitis.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Periodontitis is a chronic inflammatory disease that may ultimately lead to tooth loss as a consequence of bacterial-induced destruction of the periodontal tissues. It is characterized by an inflammatory response to dental plaque within the periodontal connective tissue and alveolar bone, and the nature and magnitude of this host response largely determine disease progression. Scaling and root planing (SRP) is considered the gold standard for the treatment of periodontitis. The cornerstone of non-surgical periodontal therapy is the mechanical removal of microbial biofilm and calculus through SRP. However, SRP alone may not be sufficient to eliminate pathogenic bacteria, as these microorganisms can persist within the gingival tissues and in anatomical areas that are difficult to access using conventional periodontal instrumentation, including deep periodontal pockets, furcation involvements, interproximal areas, and root concavities. Therefore, local or systemic antimicrobial agents and antiseptics have been recommended as adjunctive therapies to improve periodontal treatment outcomes.
Owing to its antimicrobial, anti-inflammatory, and wound-healing properties, hypochlorous acid is currently used in various dental applications, including biofilm eradication, mouth rinses, wound care, endodontic irrigation, root surface conditioning, and the treatment of peri-implantitis.
This study has been designed as a single-center, randomized, controlled, prospective clinical trial to be conducted at the Department of Periodontology, Faculty of Dentistry, Atatürk University. A total of 44 systemically healthy individuals aged 18-65 years diagnosed with Stage I or Stage II periodontitis will be enrolled in the study.
Participants will be randomly allocated into two groups using a coin-toss randomization method:
Test group: Scaling and root planing (SRP) performed using hypochlorous acid. Control group: Scaling and root planing (SRP) performed using purified water.
All participants will receive standardized oral hygiene instructions at baseline. SRP will be performed using an ultrasonic device, with hypochlorous acid as the irrigating solution in the test group and purified water in the control group.
Clinical periodontal parameters will be recorded at baseline and at the 1-month and 3-month follow-up visits. These parameters will include:
Plaque Index (PI) Probing Pocket Depth (PPD) Bleeding on Probing (BOP) Clinical Attachment Level (CAL)
At the same time points, blood and saliva samples will be collected for the analysis of C-reactive protein (CRP), high-sensitivity C-reactive protein (hs-CRP), oncostatin M (OSM), and antistreptolysin O (ASO) using enzyme-linked immunosorbent assay (ELISA).
The primary objective of this study is to evaluate the clinical efficacy of hypochlorous acid as an adjunct to scaling and root planing. The secondary objective is to investigate its effects on systemic inflammatory biomarkers.
The findings of this study are expected to contribute to the current understanding of adjunctive therapeutic strategies in periodontal treatment and to support the clinical application of hypochlorous acid as a practical and effective adjunctive approach in the management of periodontitis.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Erzurum
-
Erzurum, Erzurum, Turquie (Türkiye)
- Faculty of Dentistry, Atatürk University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Individuals aged 18 to 65 years.
- Systemically healthy individuals.
- Diagnosis of Stage I or Stage II periodontitis according to the 2017 Classification of Periodontal Diseases.
- Probing pocket depth (PPD) ≤5 mm and clinical attachment loss (CAL) ≤4 mm.
- Presence of a sufficient number of teeth for periodontal evaluation.
- Willingness to participate and ability to provide written informed consent.
Exclusion Criteria:
- Patients with contraindications to the use of ultrasonic instrumentation.
- Pregnant or lactating women.
- Patients receiving anti-inflammatory or antibiotic therapy.
- Patients with systemic diseases or medical conditions.
- Patients receiving continuous medication for any medical condition.
- Patients who have undergone periodontal treatment within the previous 6 months.
- Patients presenting with acute dental pain (e.g., pulpitis or apical/periodontal abscess).
- Individuals who smoke or consume alcohol.
- Presence of fewer than 15 teeth.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Scaling and Root Planing (SRP) with Hypochlorous Acid
Participants will undergo scaling and root planing (SRP) using hypochlorous acid.
|
Scaling and root planing (SRP) will be performed using an ultrasonic device with a hypochlorous acid solution.
|
|
Comparateur actif: Scaling and Root Planing (SRP) with Purified Water
Participants will undergo scaling and root planing (SRP) using an ultrasonic device with purified water.
|
Scaling and root planing (SRP) will be performed using an ultrasonic device with purified water.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical Attachment Level (CAL)
Délai: Baseline, 1 month and 3 months
|
Assessment of clinical attachment level (CAL), measured in millimeters, as an indicator of periodontal tissue healing.
|
Baseline, 1 month and 3 months
|
|
Probing Pocket Depth (PPD)
Délai: Baseline, 1 month and 3 months
|
Assessment of probing pocket depth (PPD), measured in millimeters, to evaluate clinical periodontal healing.
|
Baseline, 1 month and 3 months
|
|
Plaque Index (PI)
Délai: Baseline, 1 month and 3 months
|
Assessment of dental plaque accumulation.
|
Baseline, 1 month and 3 months
|
|
Bleeding on Probing (BOP)
Délai: Baseline, 1 month and 3 months
|
Assessment of gingival bleeding following periodontal probing.
|
Baseline, 1 month and 3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
C-Reactive Protein (CRP)
Délai: Baseline, 1 month, and 3 months
|
Assessment of the systemic inflammatory response by measuring serum C-reactive protein (CRP) levels.
|
Baseline, 1 month, and 3 months
|
|
High-Sensitivity C-Reactive Protein (hs-CRP)
Délai: Baseline, 1 month and 3 months
|
Assessment of low-grade systemic inflammation by measuring high-sensitivity C-reactive protein (hs-CRP) levels.
|
Baseline, 1 month and 3 months
|
|
Oncostatin M (OSM)
Délai: Baseline, 1 month and 3 months
|
Assessment of inflammatory cytokine levels associated with periodontal disease.
|
Baseline, 1 month and 3 months
|
|
Antistreptolysin O (ASO)
Délai: Baseline, 1 month and 3 months
|
Assessment of the systemic immune response associated with streptococcal exposure by measuring antistreptolysin O (ASO) levels.
|
Baseline, 1 month and 3 months
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- Maladies parodontales
- Maladies de la bouche
- Maladies stomatognathiques
- Parodontite
- Prise sèche
- Système digestif et phénomènes physiologiques oraux
- Dentisterie
- Phénomènes physiologiques dentaires
- Échelle dentaire
- Prophylaxie dentaire
- Parodontie
- Curetage de sous-gingival
- Dentisterie préventive
- Planage racinaire
- Exfoliation dentaire
Autres numéros d'identification d'étude
- ATAUNI-PERIO-HOCL-2025-001
- BAP-16024 (Autre identifiant: Atatürk University Scientific Research Projects Coordination Office)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .