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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-01-31

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.

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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.

Conditions

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Pain, Postoperative Endodontically Treated Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

the patient did not know which shaping system was used on them

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Group 1: single file rotary motion

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Group 2: multiple file rotary motion

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Group 3: single file reciprocal motion

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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OneShape Revo S WaveOne

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes