- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04700995
Postoperative Pain After Using NiTi Instruments
Postoperative Pain After Endodontic Retreatment Using Different Rotary or Reciprocating Instruments: A Randomized, Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pain (PP) is not a certain reason for the long term success of root canal treatment. However, PP control is important for patient comfort and satisfaction. Apical extrusion of debris containing dentin, necrotic pulp tissue, microorganisms, and/or irrigation solutions may occur during retreatment procedures which may result in the induction of periapical inflammation, postoperative pain, and delayed periapical healing. All available techniques and instruments are associated with apical extrusion of debris to some degree during the root canal preparation or removal of the obturation materials. The aim of this randomized clinical trial was to compare the incidence, intensity and duration of postoperative pain following the removal of root canal obturation materials canals using rotary or reciprocating file systems.
Patients referred for non-surgical endodontic retreatment were included. Hundred and eighty cases were selected on the basis of the determined inclusion criteria and randomly allocated to four groups (n = 45).
ProTaper Universal group D1, D2 and D3 files were used respectively with a full rotational motion with a endodontic motor until working was reached as recommended by the manufacturer.
Hylex EDM group Hylex EDM files were used with a full rotational motion with a endodontic motor until the working was reached.
Reciproc Blue group R25 files were used with a reciprocating motion using with the "RECIPROC ALL" mode with a slow in-and-out pecking motion, and the amplitude of pecking movements did not exceed 3 mm until the working lenght was reached.
Waveone Gold group Primary files were used with a reciprocating motion using with the "WAVEONE ALL" mode with a slow in-and-out pecking motion, and the amplitude of pecking movements did not exceed 3 mm until the working was reached.
Assessment of postoperative pain Before participation, all patients had read and signed an informed consent form., all patients were given a pain report form on which they would report their preoperative level of pain.
Before beginning of treatment, the clinician filled in an example of pain report with each patient to confirm that they understood the instructions.
The degree of the postoperative pain was measured using an 11-level numeric rating scale (NRS) at 24, 48, and 72 h following the retreatment. The NRS is a segmented numeric version of the visual analog scale (VAS) and consists of successive numbers from 0 to 10 on a horizontal line. The respondent selects a number that best represents the intensity of his pain. Number "0" represents "no pain" whereas number "10" represents "the worst pain imaginable".
Patients were asked to fill out forms at relevant times in accordance with the instructions given.
An analgesic tablet (400 mg Ibuprofen) was prescribed to take an in case of severe pain, at 6-h intervals. Also they were requested to record the number of analgesic pills consumed each day. The forms were collected on the 4th day following the retreatment. Also a phone call was made every day for 3 days to obtain information on the postoperative pain and the frequency of analgesic intake. The patients were asked to call the contact number on the form if they encountered severe pain or if they needed to ask any questions regarding the treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Edirne, Turkey, 22061
- Burhan Çanakçi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Systemically healthy patient who has a failed root canal treatment.
- Asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic apical periodontitis.
- Patients agreed to parcitipate in the study
Exclusion Criteria:
- Overfilled teeth,
- teeth with intraradicular posts,
- existence of a sinus tract,
- consumption of antibiotics or analgesics within one month,
- pregnancy,
- history of trauma,
- traumatic occlusion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ProTaper rotary NiTi instruments
The ProTaper Universal Retreatment rotary system and ProTaper Gold rotary system were used.
|
Root canal filling removal
|
Experimental: Hyflex EDM rotary NiTi instruments
Hyflex EDM rotary system was used.
|
Root canal filling removal
|
Experimental: Reciproc Blue reciprocating NiTi instruments
Reciproc Blue reciprocating system was used.
|
Root canal filling removal
|
Experimental: Waveone Gold reciprocating NiTi instruments
WaveOne Gold reciprocating system was used.
|
Root canal filling removal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Time Frame: 24 hours postoperatively
|
Pain intensity was evaluated at 24 hours after retreatment procedures.
An 11 item numerical rating scale (NSR) was used to assess the pain.
The NSR is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain.
The number 0 represents "no pain" wheres number 10 represents "pain as bad as someone can imagine".
All patients were requested to mark a number corresponding to their average pain.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Time Frame: 24 to 48 hours postoperatively
|
Pain intensity was evaluated at 48 hours after retreatment procedures.
An 11 item numerical rating scale (NSR) was used to assess the pain.
The NSR is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain.
The number 0 represents "no pain" wheres number 10 represents "pain as bad as someone can imagine".
All patients were requested to mark a number corresponding to their average pain.
|
24 to 48 hours postoperatively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Time Frame: 48 to 72 hours postoperatively
|
Pain intensity was evaluated at 72 hours after retreatment procedures.
An 11 item numerical rating scale (NSR) was used to assess the pain.
The NSR is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain.
The number 0 represents "no pain" wheres number 10 represents "pain as bad as someone can imagine".
All patients were requested to mark a number corresponding to their average pain.
|
48 to 72 hours postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Burhan Çanakçi, Trakya University, Faculty of Dentistry
- Study Director: Özgür Er, Trakya University, Faculty of Dentistry
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Pain
- Neurologic Manifestations
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Tooth Diseases
- Jaw Diseases
- Dental Pulp Diseases
- Periapical Diseases
- Pain, Postoperative
- Periodontitis
- Inflammation
- Postoperative Complications
- Pulpitis
- Periapical Periodontitis
- Tooth, Nonvital
Other Study ID Numbers
- TrakyaU 2020/150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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