Electrolysed Saline Rinse as an Adjunct for Treatment of Chronic Periodontitis (EOSPERIO)

Influence of Adjunctive Electrolysed Saline Rinse in Stage III Periodontitis Patients

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). The study will include 60 subjects selected from consecutively scheduled patients referred by their personal dentists for periodontal treatment at the Dental Clinic of University Medical Centre Ljubljana.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Other: Electrolysed saline rinse; Device: Chlorhexidine 0,12%; Device: Distilled water group

Detailed Description

Before enrolment in the study, a thorough clinical examination of each patient will be performed, which will involve assessing several periodontal parameters at six sites around each tooth on all teeth, excluding third molars: plaque index (PlI), probing depth (PD), gingival recession (GR), clinical attachment loss (CAL), bleeding on probing (BOP), furcation involvement, and tooth mobility. All clinical parameters will be measured using a William's periodontal probe (Hu-Friedy, USA, PQW6). Local X-rays of sites affected by periodontitis will be taken. The performed clinical examination will not differ in any way from the examination conducted on all patients, even those not included in our study. The population of included subjects will consist of individuals of both sexes, aged 25-70 years, smokers and non-smokers, with moderate or advanced stage of chronic periodontitis (stage III, IV). They will be selected based on the following 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). Individuals will be excluded that: 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. Patients will be informed about the purpose of the research in writing. Prior to the commencement of the study, all patients will fill out an informed consent form.

Subjects will then be divided into three groups of 20; the first group will use a mouthwash consisting of EOS (active ingredient) for one month after the non-surgical treatment; the second group will use a mouthwash containing CHX (positive control); and the third group will use distilled water (negative control/placebo). Randomization will be performed using a computer program. Only one member of the research group, who will also prepare the mouthwashes, will know the content of the randomization table or the type of mouthwash used by each individual. Identification codes will remain hidden from all other researchers and subjects until the final follow-up examinations. The packaging of the mouthwashes will be identical, and the active ingredients will not be distinguishable by color.

Samples of subgingival fluid will be collected at the beginning of the test period for the purpose of microbiological characterization using sterile paper points from the buccal surface of four teeth (sites with the greatest probing depths in each quadrant) and transported to the laboratory of the Institute of Microbiology and Immunology using a transport medium (RTF). The microbiological analysis will be performed using Quantitative Polymerase Chain Reaction (qPCR).

Subsequently, all patients will undergo a non-surgical periodontal treatment, which will include instruction and motivation for proper oral hygiene, removal of hard and soft plaque deposits using a piezoelectric device and ultrasonic tip, and root planing and scaling under local anesthesia. Each subject will then receive a package with an identification number and the label A, B, or C on it, according to the computer-generated randomization scheme. One-third of the patients will receive EOS in the package, one-third will receive CHX, and one-third will receive distilled water. Subjects will then rinse their oral cavities with 15 ml of their allocated mouthwash twice daily (in the morning and evening) for 30 seconds for four consecutive weeks.

After four weeks, subjects will be invited for their first follow-up examination. They will report any side effects and return the packaging of the for compliance control. They will also be asked about the organoleptic properties of the mouthwash they used. A thorough clinical examination will be performed again and collect samples of subgingival fluid in the same manner as during the initial examination. The second follow-up examination will be conducted three months after the oral hygiene phase and will include a clinical assessment and collection of subgingival fluid samples.

The primary outcome variable will be the number of residual diseased sites (PD > 4mm + BOP). Secondary outcome variables will include plaque index assessment, BOP, PD, and quantity of periodontopathogens. Since teeth are "nested" within patients and probing sites are "nested" within teeth, the collected data is interdependent. A multilevel multiple logistic regression model will therefore be used to examine associations between variables.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rok Gašperšič, PhD; Phone Number: 0038615224889; Email: rok.gaspersic@mf.uni-lj.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • University Medical Centre Ljubljana
    • Contact: Rok Gašperšič, PhD; Phone Number: 0038615224889; Email: rok.gaspersic@mf.uni-lj.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EOS	Other: Electrolysed saline rinse; EOS ph = 7, 200 ppm free available Chlorine
Active Comparator: CHX	Device: Chlorhexidine 0,12%; 0.12% pharmaceutical formulation will be used as an active comparator
Placebo Comparator: Placebo - distilled water	Device: Distilled water group; Distilled water will be used as a negative placebo mouth-rinse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
No of residual diseased sites	Probing Pocket Depth (PPD) > 4 mm + Bleeding On Probing (BOP)	Baseline, 1 month, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Pocket Depth (PPD)		Baseline, 1 month, 3 months
Clinical Attachment Level (CAL)		Baseline, 1 month, 3 months
Full Mouth Plaque Score (FMPS)	Calculation of plaque positive measuring sites ration in % (positive/all sites)	Baseline, 1 month, 3 months

Other Outcome Measures

Outcome Measure	Time Frame
Absolute number and share of 14 periodontopathogenic species	Baseline, 1 month, 3 months

Collaborators and Investigators

• Sponsor: University of Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Estimated): June 6, 2026
• Study Completion (Estimated): December 6, 2026

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: UKCLJEOSPERIO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No