Health TrialsbyHealthPanel

Electrolysed Saline Rinse as an Adjunct for Treatment of Chronic Periodontitis

ConditionPeriodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Ljubljana

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Electrolysed saline rinse

    Other intervention

    EOS ph = 7, 200 ppm free available Chlorine

  • Distilled water group

    Device

    Distilled water will be used as a negative placebo mouth-rinse

  • Chlorhexidine 0,12%

    Device

    0.12% pharmaceutical formulation will be used as an active comparator

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: EOSExperimental treatment 1 intervention
Group B: CHXActive comparator 1 intervention
Group C: Placebo - distilled waterPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

No of residual diseased sites

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

Time frame
Baseline, 1 month, 3 months

Secondary outcomes

1

Probing Pocket Depth (PPD)

Time frame
Baseline, 1 month, 3 months
2

Clinical Attachment Level (CAL)

Time frame
Baseline, 1 month, 3 months
3

Full Mouth Plaque Score (FMPS)

Calculation of plaque positive measuring sites ration in % (positive/all sites)

Time frame
Baseline, 1 month, 3 months

Other outcomes

1

Absolute number and share of 14 periodontopathogenic species

Time frame
Baseline, 1 month, 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Ljubljana

Lead sponsor

Source ClinicalTrials.gov
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