Back to resultsComparative Evaluation of the Effectiveness of Root Canal Preparation After Irrigation Using Endodontic Needle and Inertial Cavitation
Primary Purpose
Root Canal Treatment, Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional irrigation
Inertial cavitation
Sponsored by
About this trial
This is an interventional device feasibility trial for Root Canal Treatment focused on measuring Root Canal Irrigation, Root Canal Cleaning, Root Canal Treatment, Post Operative Pain, Root Canal Disinfection, Inertial cavitation, NaOCl Irrigation, Sodium hypochlorite (NaOCl) irrigation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Teeth with root apices extending into the maxillary sinus
- Teeth with external resorption communicating with the pulp
Sites / Locations
- İstanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional irrigation
Inertial cavitation
Arm Description
Root canal cleaning will be performed by manual irrigation with sodium hypochlorite NaOCl solution.
Root canal cleaning will be performed by inertial cavitation-generating device.
Outcomes
Primary Outcome Measures
Clinical postoperative pain
VAS score of patient's level of pain, from no pain to extreme pain
Clinical postoperative pain
VAS score of patient's level of pain, from no pain to extreme pain
Clinical postoperative pain
VAS score of patient's level of pain, from no pain to extreme pain
Clinical postoperative pain
VAS score of patient's level of pain, from no pain to extreme pain
Clinical postoperative pain
VAS score of patient's level of pain, from no pain to extreme pain
Secondary Outcome Measures
Full Information
NCT ID
NCT05374434
First Posted
May 10, 2022
Last Updated
August 24, 2022
Sponsor
Lumendo AG
Collaborators
Soteria Danışmanlık
1. Study Identification
Unique Protocol Identification Number
NCT05374434
Brief Title
Comparative Evaluation of the Effectiveness of Root Canal Preparation After Irrigation Using Endodontic Needle and Inertial Cavitation
Official Title
Comparative Evaluation of the Effectiveness of Root Canal Preparation After Irrigation Using Endodontic Needle and Inertial Cavitation: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumendo AG
Collaborators
Soteria Danışmanlık
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Sodium hypochlorite (NaOCl) irrigation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional irrigation
Arm Type
Active Comparator
Arm Description
Root canal cleaning will be performed by manual irrigation with sodium hypochlorite NaOCl solution.
Arm Title
Inertial cavitation
Arm Type
Experimental
Arm Description
Root canal cleaning will be performed by inertial cavitation-generating device.
Intervention Type
Other
Intervention Name(s)
Conventional irrigation
Intervention Description
The participant will be treated by manual irrigation with sodium hypochlorite NaOCl.
Intervention Type
Device
Intervention Name(s)
Inertial cavitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical postoperative pain
Description
VAS score of patient's level of pain, from no pain to extreme pain
Time Frame
6 hours
Title
Clinical postoperative pain
Description
VAS score of patient's level of pain, from no pain to extreme pain
Time Frame
24 hours
Title
Clinical postoperative pain
Description
VAS score of patient's level of pain, from no pain to extreme pain
Time Frame
48 hours
Title
Clinical postoperative pain
Description
VAS score of patient's level of pain, from no pain to extreme pain
Time Frame
72 hours
Title
Clinical postoperative pain
Description
VAS score of patient's level of pain, from no pain to extreme pain
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Teeth with root apices extending into the maxillary sinus
Teeth with external resorption communicating with the pulp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tan Firat EYÜBOĞLU, DDS, PhD
Organizational Affiliation
İstanbul Medipol University, Faculty of Dentistry, Department of Endodontics, Atatürk Bul. No:27, 34083 Unkapanı, Fatih İstanbul/Türkiye
Official's Role
Principal Investigator
Facility Information:
Facility Name
İstanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics
City
Istanbul
State/Province
Unkapanı, Fatih
ZIP/Postal Code
34083
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparative Evaluation of the Effectiveness of Root Canal Preparation After Irrigation Using Endodontic Needle and Inertial Cavitation
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