Electrolysed Saline Rinse As an Adjunct for Treatment of Chronic Periodontitis

NCT06692582 | Recruiting

• 1 other identifier: UKCLJEOSPERIO1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• No of residual diseased sites

  Probing Pocket Depth (PPD) \> 4 mm + Bleeding On Probing (BOP)

  Baseline, 1 month, 3 months

Secondary Outcomes (3)

• Probing Pocket Depth (PPD)

  Baseline, 1 month, 3 months

• Clinical Attachment Level (CAL)

  Baseline, 1 month, 3 months

• Full Mouth Plaque Score (FMPS)

  Baseline, 1 month, 3 months

Other Outcomes (1)

• Absolute number and share of 14 periodontopathogenic species

  Baseline, 1 month, 3 months

Study Arms (3)

EOS

EXPERIMENTAL

Other: Electrolysed saline rinse

CHX

ACTIVE COMPARATOR

Other: Electrolysed saline rinse

Placebo - distilled water

PLACEBO COMPARATOR

Other: Electrolysed saline rinse

Interventions

Electrolysed saline rinse OTHER

EOS ph = 7, 200 ppm free available Chlorine

CHX; EOS; Placebo - distilled water

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Rok Gašperšič, PhD

CONTACT

0038615224889; rok.gaspersic@mf.uni-lj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: June 6, 2024
• Primary Completion: December 6, 2025
• Study Completion (Estimated): December 6, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

SL (1)