NCT06692582 Electrolysed Saline Rinse As an Adjunct for Treatment of Chronic Periodontitis
| NCT ID | NCT06692582 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ljubljana |
| Condition | Periodontitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2025-12-06 |
Trial Parameters
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Brief Summary
The study will be conducted as a prospective, double-blind, parallel, randomized, placebo-controlled study at the Dental Clinic of University Medical Centre Ljubljana. It will involve a one-month test period, during which the test subjects will use either placebo, Electrolysed Oxidising Saline (EOS) or chlorhexidine (CHX) in the form of a mouthwash as an adjunct to the non-surgical treatment of chronic periodontitis (i.e. root planing and scaling). We will include 60 subjects who will be selected from consecutively scheduled patients referred by their personal dentists for periodontal treatment at the Dental Clinic of University Medical Centre Ljubljana.
Eligibility Criteria
Inclusion Criteria: Clinical attachment loss ≥ 5 mm on at least two teeth in two different jaw quadrants; presence of stable occlusion and at least 16 teeth, among which at least 12 teeth are suitable for evaluation (excluding wisdom teeth, teeth with orthodontic wires, bridges, crowns, and implants). Exclusion Criteria: We will exclude individuals who: suffer from chronic systemic diseases (diabetes, cancer, HIV infection, metabolic bone diseases, and diseases that interfere with wound healing processes); are undergoing radiation or chemotherapy; are taking immunosuppressants, antiepileptic drugs, calcium antagonists, nonsteroidal anti-inflammatory drugs; have been treated with antibiotics in the past 12 months; have a known allergy to CHX; have undergone scaling and root planing or surgical periodontal treatment in the past year; are pregnant or breastfeeding.