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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478241
• Other study ID #: 481
• Status: Completed
• Phase: N/A
• First received: March 14, 2018
• Last updated: March 26, 2018
• Start date: September 2016
• Est. completion date: January 2017

Study information

• Verified date: March 2018
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Pain
• Pain, Postoperative
• Tooth, Nonvital

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	unscheduled appointment for emergency intervention	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	1 month
Other	presence of complications	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	1 month
Primary	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