Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems

Study Overview
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Brief Summary
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In this study the effect of different engine-driven nickel titanium (Ni-Ti) instrumentation systems (OneShape, Revo S and WaveOne) on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal retreatment was evaluated.

Detailed Description
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The aim of this clinical study was to evaluate the effect of different engine-driven nickel titanium (Ni-Ti) instrumentation systems (OneShape, Revo S and WaveOne) on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal retreatment. A total of a hundred thirty nine patients with asymptomatic teeth and with no contradictory medical history who were indicated for non-surgical retreatment at the Endodontic Clinic, Faculty of Dentistry, Istanbul Medipol University, between September and December 2016 were included in this study. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Out of a hundred thirty nine patients, a total of ninety-nine patients who met the inclusion criteria and agreed to participate was enrolled for the study and were divided into three groups (n=33). Consent was obtained from all study participants before the treatment. After removing previous root canal filling, instrumentation was performed using One Shape, Revo-S, and WaveOne in groups 1, 2, and 3, respectively. All retreatments were performed in a single appointment by one endodontist before permanent coronal restoration. Postoperative pain intensity was assessed at 6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month after the retreatment. The teeth was examined according to for pain intensity, percussion & palpation sensitivity, swelling, analgesic intake and clinical status.

Official Title
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Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems During Single-Appointment Non-Surgical Endodontic Retreatment: A Randomized Clinical Trial

Conditions
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Pain, Postoperative, Endodontically Treated Teeth

Intervention / Treatment
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* Device: Group 1: single file rotary motion
* Device: Group 2: multiple file rotary motion
* Device: Group 3: single file reciprocal motion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asymptomatic teeth Patients with no contradictory medical history Patients who were indicated for non-surgical retreatment and Patients who were above 18 years old Exclusion Criteria: Patients aged below 18 years; Symptomatic teeth, Teeth with vertical root fractures Teeth with excessive periodontal disease; Patients who received or required surgical endodontic treatment Patients diagnosed with systemic diseases Patients who used analgesics 12 h before or Patients who used antibiotics 1 month before the retreatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: after each group has been treated with their respective Ni-Ti root canal shaping system, post operative pain was assessed at 6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: single file rotary motion<br>after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using OneShape Ni-Ti system. | Device: Group 1: single file rotary motion<br>* after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using OneShape Ni-Ti system. the obturation process was completed prior to coronal restoration either with direct or indirect methods<br>* Other names: OneShape;|
| Active Comparator: Group 2: multiple file rotary motion<br>after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using Revo S Ni-Ti system. | Device: Group 2: multiple file rotary motion<br>* after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using Revo S Ni-Ti system. the obturation process was completed prior to coronal restoration either with direct or indirect methods<br>* Other names: Revo S;|
| Active Comparator: Group 3: single file reciprocal motion<br>after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using WaveOne Ni-Ti system. | Device: Group 3: single file reciprocal motion<br>* after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using WaveOne Ni-Ti system. the obturation process was completed prior to coronal restoration either with direct or indirect methods<br>* Other names: WaveOne;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Postoperative Pain after single appointment retreatment at 1 month | The primary outcome measure of the study was to assess if different nickel titanium root canal shaping systems influence the intensity and duration of postoperative pain in single-visit non-surgical root canal re-treatments. Postoperative pain was recorded using a four-level verbal rating scale, where 0 indicated no pain, 1 indicated slight pain, 2 indicated moderate pain, and 3 indicated sever pain. the patients were asked to return to the clinic for assessing postoperative pain (tenderness to palpation and percussion) at 24, 48, and 72 h; 7 days; and 1 month after the treatment. One clinician performed all the assessments at 24, 48, and 72 h; 7 days; and 1 month. | 6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endodontic retreatment, postoperative pain, OneShape, Revo-S, WaveOne