Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07257887

Assessment of the Efficacy and Safety of OROXIDae Oral Solution in Patients With Periodontitis

Led by ENIKAM d.o.o. · Updated on 2025-12-02

90

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Periodontitis is a chronic inflammatory disease that damages the structures supporting the teeth, often caused by bacteria in dental plaque. It usually starts as gingivitis, which is a reversible gum inflammation. Without proper oral hygiene and treatment, gingivitis can progress to periodontitis, leading to loss of tooth support and eventually tooth loss. Early diagnosis and treatment are important to prevent this progression. This study aims to evaluate the safety and effectiveness of two hydrogen peroxide mouth rinses as additional treatments for periodontitis. The study will compare two concentrations of hydrogen peroxide mouth rinses: a 1.5% solution called Oroxidae sensitive and a 3% solution called Oroxidae forte. Participants will use either oral solution two to three times daily for 12 weeks alongside their standard dental care. A control group will receive standard care alone, which includes proper tooth brushing without mouth rinses or other products aimed at reducing oral bacteria. The study is randomized and does not involve blinding. Participants will be assessed at the start and after 12 weeks for gum health using measures such as probing depth and bleeding on probing. Additional evaluations include plaque and gingival indices, infection rates, and monitoring of adverse events throughout the 12-week period. The study involves adults with Stage III, Grade B periodontitis who meet specific dental and health criteria. The goal is to gather more data on how these mouth rinses may support periodontal treatment over three months of use.

CONDITIONS

Brief Title

Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Periodontitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Systemically healthy participants aged 18 years or older
  • Diagnosed with generalized periodontitis, Stage III, Grade B
  • Have three or more periodontal pockets deeper than 5 mm
  • Possess at least 16 natural teeth excluding wisdom teeth
  • Able to follow oral hygiene instructions after treatment
  • Provided signed informed consent after full study information
Not Eligible

You will not qualify if you...

  • Received periodontal treatment within the past six months
  • Had dental procedures like surgery, professional cleaning, scaling and root planing, laser therapy, or piezotome in past six months
  • Diagnosed with periodontitis Stage IV
  • Used mouth rinses or oral gels within the past month
  • Used antibiotic therapy within the past three months
  • Currently on antihypertensives, antilipemics, antiarrhythmics, or other cardiovascular medicines
  • Have systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic kidney disease, tuberculosis, or autoimmune disorders
  • History of cardiovascular diseases like heart attack, angina, heart failure, atrial fibrillation, heart block, peripheral artery disease, or stroke
  • Receiving immunosuppressive therapy
  • Allergic to any ingredients of the study products
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 12 weeks

Participants use OROXID® forte or sensitive oral solution two to three times daily for 12 weeks as an adjunct to standard care, or receive standard care alone with proper tooth brushing without mouthwash or other oral hygiene products.

Baseline visit and 1 follow-up visit at Week 12

Trial Site Locations

Total: 2 locations

1

Klinika Križaj Ljubljana

Ljubljana, Slovenia, 1000

Actively Recruiting

2

Ustna medicina d.o.o.

Ljubljana, Slovenia, 1000

Actively Recruiting

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Research Team

D

Dominika Tompa Majcen, MPharm

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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