Clinical trial NCT03478241: Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Endodontically Treated Teeth
Keywords: Endodontic retreatment
postoperative pain
OneShape
Revo-S
WaveOne
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.

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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline in Postoperative Pain after single appointment retreatment at 1 month
timeFrame: 6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month
Secondary outcomes:
Other outcomes:
measure: unscheduled appointment for emergency intervention
timeFrame: 1 month
measure: presence of complications
timeFrame: 1 month
Locations:
Study officials:
affiliation: Medipol University
name: TAN FIRAT EYUBOGLU, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: