Status:

RECRUITING

A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material.

Lead Sponsor:

Lumendo AG

Collaborating Sponsors:

Avania

Conditions:

Endodontic Treatment

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

The goal of this study is prospective, single-arm, non-randomized controlled trial to test the effectiveness, safety and performance of a novel dental obturation material. The main question sit answer...

Detailed Description

Study Title: "A prospective, single-arm, non-randomized controlled trial to test the effectiveness, safety and performance of a novel dental obturation material." Protocol Version and Date: Version ...

Eligibility Criteria

Inclusion Criteria:

• Patients aged 18-75 years with ASA (American Society of Anesthesiologists) classification 1 and 2.

ASA 1: A normal healthy patient. Example: Fit, non-obese BMI (Body Mass Index) under 30, a non-smoking patient with good exercise tolerance.

ASA 2: A patient with mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (e.g., treated hypertension, obesity with BMI under 35, frequent social drinker, or cigarette smoker).

  • Patients who agreed to participate and who have signed the informed consent.
  • Patients presenting with symptomatic and/or asymptomatic apical periodontitis and radiographic evidence of apical periodontitis in anterior or posterior teeth larger than 1.5 mm in diameter.
  • Mature tooth with closed apices.
  • Tooth that has never been treated with root canal therapy.

Exclusion Criteria:

  • Patients who have pre-existing health or oral conditions that placed them at risk during the trial.
  • Patients with generalized untreated periodontal disease.
  • Patients with a history of analgesic intake within the past 3 days or antibiotics in the last 1 month.
  • Uncooperative patients.
  • Teeth with immature apices, root resorption, or requiring extensive prosthetic rehabilitation.
  • Teeth that cannot be made functional nor restored or difficult to access teeth with no importance (wisdom teeth).
  • Teeth with insufficient periodontal support.
  • Teeth with poor prognosis for root canal treatment, for example due to deep root caries, large root resorption or open apex cases.
  • Fractured teeth
  • Local anatomical factors such as an inaccessible root end
  • Presence of fractured instrument in the root canal
  • Pregnant women
  • Patients unable to understand the study procedure.

Key Trial Info

Start Date :

June 7 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

63 Patients enrolled

Trial Details

Trial ID

NCT06312085

Start Date

June 7 2024

End Date

December 1 2026

Last Update

July 12 2024

Active Locations (1)

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1

Medipol University

Istanbul, Turkey (Türkiye)