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

• ClinicalTrials.gov Identifier: NCT03478241
• Recruitment Status: Completed
• First Posted: March 27, 2018
• Last Update Posted: March 27, 2018
• Sponsor: Istanbul Medipol University Hospital
• Information provided by (Responsible Party): Tan Firat Eyuboglu, Istanbul Medipol University Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative; Endodontically Treated Teeth	Device: Group 1: single file rotary motion; Device: Group 2: multiple file rotary motion; Device: Group 3: single file reciprocal motion	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Participant)
• Masking Description: the patient did not know which shaping system was used on them
• Primary Purpose: Screening
• Official Title: Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems During Single-Appointment Non-Surgical Endodontic Retreatment: A Randomized Clinical Trial
• Actual Study Start Date: September 2016
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: January 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group 1: single file rotary motion; 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; 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; Other Name: OneShape
Active Comparator: Group 2: multiple file rotary motion; 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; 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; Other Name: Revo S
Active Comparator: Group 3: single file reciprocal motion; 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; 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; Other Name: WaveOne

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline in Postoperative Pain after single appointment retreatment at 1 month [ Time Frame: 6, 12, 18, 24, 48, and 72 h; 7 days; and 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.

Other Outcome Measures:

1. unscheduled appointment for emergency intervention [ Time Frame: 1 month ]
   the presence or absence of unscheduled appointment for emergency dental intervention was recorded on the chart of the patient as "present" or "absent" during the observation time
2. presence of complications [ Time Frame: 1 month ]
   the absence or presence of complications (such as swelling or parasthesia) after the intervention was recorded on the chart of the patient as "present" or "absent" during the observation time

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Istanbul Medipol University Hospital

Investigators

• Principal Investigator: TAN FIRAT EYUBOGLU, DDS, PhD; Medipol University

More Information

• Responsible Party: Tan Firat Eyuboglu, Assistant Professor, Istanbul Medipol University Hospital
• ClinicalTrials.gov Identifier: NCT03478241
• Other Study ID Numbers: 481
• First Posted: March 27, 2018
• Last Update Posted: March 27, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tan Firat Eyuboglu, Istanbul Medipol University Hospital:

Endodontic retreatment; postoperative pain; OneShape; Revo-S; WaveOne

Additional relevant MeSH terms:

Tooth, Nonvital; Pain, Postoperative; Pain; Postoperative Complications; Pathologic Processes; Neurologic Manifestations; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases