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

NCT03478241 | Completed

• 1 other identifier: 481
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative; Endodontically Treated Teeth

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• unscheduled appointment for emergency intervention

  1 month

• presence of complications

  1 month

Study Arms (3)

Group 1: single file rotary motion

ACTIVE COMPARATOR

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

Group 2: multiple file rotary motion

ACTIVE COMPARATOR

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

Group 3: single file reciprocal motion

ACTIVE COMPARATOR

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

Interventions

Group 1: single file rotary motion DEVICE

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

Also known as: OneShape

Group 1: single file rotary motion

Group 2: multiple file rotary motion DEVICE

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

Also known as: Revo S

Group 2: multiple file rotary motion

Group 3: single file reciprocal motion DEVICE

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

Also known as: WaveOne

Group 3: single file reciprocal motion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asymptomatic teeth
• Patients with no contradictory medical history
• Patients who were indicated for non-surgical retreatment and
• Patients who were above 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative; Tooth, Nonvital

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• TAN FIRAT EYUBOGLU, DDS, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the patient did not know which shaping system was used on them
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 27, 2018
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share