Comparative Evaluation of the Effectiveness of Root Canal Preparation After Irrigation Using Endodontic Needle and Inertial Cavitation: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Clinical Postoperative Pain
Study Overview
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.
Detailed Description
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 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 Confidential
- Teeth with root apices extending into the maxillary sinus
All treatment procedures will be performed in a single visit by a single treatment provider. It will be assured that the operation room is quiet and isolated throughout the whole process to avoid any outside interference. Patients will be made comfortable and informed about the steps of the procedure a second time right before commencing the treatment protocol. Patients will be also reminded that they will get the necessary treatment even if they decline from the study and should not feel compelled to participate the study for a proper treatment. All root canal treatments will be performed using a dental loupe with a magnification of 4.50X (EyeMag Pro F; Carl Zeiss).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Clinical Postoperative Pain
Time Frame: 1 week
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.
Secondary Outcomes
No secondary outcomes reported