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

NCT06312085 | Recruiting

• 1 other identifier: EF_5301_V1.0_CIP
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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 answers is

1. 1.To test the effectiveness of the Endofill device for root canal obturation up to 12-month follow-up period.
2. 2.To test the performance of the Endofill device evaluated with periapical radiographs immediately on completion of procedure.

Conditions

Endodontic Treatment

Keywords

Root Canal Treatment

Outcome Measures

Primary Outcomes (1)

• Effectiveness of root canal treatment using Endofill

  To measure effectiveness by assessing overall healing, through rate of reduction in apical periodontitis, from baseline up to 12 months post-procedure by measuring periapical radiolucency size.

  12 months

Secondary Outcomes (1)

• Safety of root canal treatment using endofill

  1 month

Study Arms (1)

Endofill arm

EXPERIMENTAL

Endofill arm- This arm will receive the novel obturation material after root canal preparation and success of root canal treatment will be measured after 12 months

Device: Endofill

Interventions

Endofill DEVICE

Endofill is intended for the permanent obturation of root canals following root canal preparation and disinfection.

Also known as: Odnefill

Endofill arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lumendo AG: lead
• Avania: collaborator

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

• Tan Firat Eyuboglu, Prof. Dr.

  Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anupama Tripathi

CONTACT

+4144 589 68 03; anupama.tripathi@odne.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 15, 2024
• Study Start: June 7, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)