A First in Human Study to Compare Feasibility of Inertial Cavitation Irrigation to SNI in Root Canal Treatment.

NCT05374434 | Completed Results

• 1 other identifier: LUM-EC-001-060522
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study design is a single-center 2-arm randomized controlled clinical trial. 10 subjects (teeth) requiring a root canal treatment will be enrolled in 2 groups (5 in each group). The aim of the study is to compare the postoperative pain intensity levels in patients with asymptomatic teeth diagnosed for non-surgical orthograde root canal treatment that are disinfected during the root canal treatment procedure by manual irrigation with sodium hypochlorite (NaOCl) solution using an endodontic needle or by a inertial cavitation-generating device.

Conditions

Root Canal Treatment; Post Operative Pain

Keywords

Root Canal Irrigation; Root Canal Cleaning; Root Canal Treatment; Post Operative Pain; Root Canal Disinfection; Inertial cavitation; NaOCl Irrigation; Debridement

Outcome Measures

Primary Outcomes (5)

• Clinical Postoperative Pain

  Pain intensity levels were graded using Visual Analog Scale (VAS). This scale is a horizontal 100 mm bar, marked in every 10mm with two ends. One end (0) indicated "no pain" and the other end (100) indicated "worst pain possible". Categorization of pain scores is as follows: 0-4 mm = No Pain, 5-44 mm = Mild Pain, 45-74 mm = Moderate Pain, 75-100 mm = severe pain.

  6 hours

• Clinical Postoperative Pain

  Pain intensity levels were graded using Visual Analog Scale (VAS). This scale is a horizontal 100 mm bar, marked in every 10mm with two ends. One end (0) indicated "no pain" and the other end (100) indicated "worst pain possible". Categorization of pain scores is as follows: 0-4 mm = No Pain, 5-44 mm = Mild Pain, 45-74 mm = Moderate Pain, 75-100 mm = severe pain.

  24 hours

• Clinical Postoperative Pain

  Pain intensity levels were graded using Visual Analog Scale (VAS). This scale is a horizontal 100 mm bar, marked in every 10mm with two ends. One end (0) indicated "no pain" and the other end (100) indicated "worst pain possible". Categorization of pain scores is as follows: 0-4 mm = No Pain, 5-44 mm = Mild Pain, 45-74 mm = Moderate Pain, 75-100 mm = severe pain.

  48 hours

• Clinical Postoperative Pain

  Pain intensity levels were graded using Visual Analog Scale (VAS). This scale is a horizontal 100 mm bar, marked in every 10mm with two ends. One end (0) indicated "no pain" and the other end (100) indicated "worst pain possible". Categorization of pain scores is as follows: 0-4 mm = No Pain, 5-44 mm = Mild Pain, 45-74 mm = Moderate Pain, 75-100 mm = severe pain.

  72 hours

• Clinical Postoperative Pain

  Pain intensity levels were graded using Visual Analog Scale (VAS). This scale is a horizontal 100 mm bar, marked in every 10mm with two ends. One end (0) indicated "no pain" and the other end (100) indicated "worst pain possible". Categorization of pain scores is as follows: 0-4 mm = No Pain, 5-44 mm = Mild Pain, 45-74 mm = Moderate Pain, 75-100 mm = severe pain.

  1 week

Study Arms (2)

Conventional irrigation

ACTIVE COMPARATOR

Root canal cleaning will be performed by manual irrigation with sodium hypochlorite NaOCl solution.

Other: Conventional irrigation

Inertial cavitation

EXPERIMENTAL

Root canal cleaning will be performed by inertial cavitation-generating device.

Device: Inertial cavitation

Interventions

Conventional irrigation OTHER

The participant will be treated by manual irrigation with sodium hypochlorite NaOCl.

Conventional irrigation

Inertial cavitation DEVICE

The participant will be treated by inertial cavitation-generating device, that generates hydraulic cavitation to clean root canals deeper and more effectively than other existing systems.

Inertial cavitation

Eligibility Criteria

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

You may qualify if:

• Physical status classification system described was used for patients' recruitment. Healthy patients, who were classified by the American Society of Anaesthesiologists (ASA) as ASA I and II
• Patients with the age of 18 and over
• Patients who were diagnosed as in need of non-surgical orthograde root canal treatment of an asymptomatic tooth
• Tooth without signs of previously initiated Root Canal Therapy

You may not qualify if:

• Pregnant and lactating females
• Patients with chronic periodontal diseases
• Patients with sensitivity or adverse reactions to any medication or materials that were used throughout the treatment procedure
• Patients with acute periapical periodontitis
• Patients with acute periodontal abscess
• Patients who could not abide by the follow-up time
• Patients who used analgesics 1-week prior or antibiotics 1-month prior to treatment
• Uncooperative patients
• Teeth that cannot be made functional nor restored or difficult to access teeth with no importance (wisdom teeth)
• Teeth with poor prognosis, for example, due to deep root caries or big root resorption
• Teeth with more than/or equal 4 mm periodontal pocket depth
• Teeth with an inaccessible root end
• Teeth with apical resorption or a radiologically not clearly defined apex
• Fractured teeth
• Teeth with immature or open apices

Sponsors & Collaborators

• Lumendo AG: lead

Study Sites (1)

İstanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics

Istanbul, Unkapanı, Fatih, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Mark Bispinghoff
• Organization: Lumendo

mark.bispinghoff@lumendo.ch

+41 44 589 68 02

Study Officials

• Tan Firat EYÜBOĞLU, DDS, MDS

  İstanbul Medipol University, Department of Endodontics, İstanbul/Türkiye

  PRINCIPAL INVESTIGATOR

• Mutlu ÖZCAN, DDS, MDS

  İstanbul Medipol University, Istanbul Turkey

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: May 10, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: July 25, 2024
• Results First Posted: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)