Pain, PostoperativeNCT03478241
Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems
A study testing Group 1: single file rotary motion, Group 2: multiple file rotary motion and Group 3: single file reciprocal motion in people with Pain, Postoperative and Endodontically Treated Teeth, run by Istanbul Medipol University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Endodontically Treated Teeth
- What is being tested?
- Group 1: single file rotary motion, Group 2: multiple file rotary motion and Group 3: single file reciprocal motion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic teeth
- Patients with no contradictory medical history
- Patients who were indicated for non-surgical retreatment and
- Patients who were above 18 years old
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Pain, Postoperative, Endodontically Treated Teeth
- Being tested
- Group 1: single file rotary motion, Group 2: multiple file rotary motion, Group 3: single file reciprocal motion
- Keywords
- Endodontic retreatment, postoperative pain, OneShape, Revo-S, WaveOne
- Medical subject headings
- Pain, Postoperative, Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: single file rotary motionDevice
Also called OneShape
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 motionDevice
Also called Revo S
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 motionDevice
Also called WaveOne
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Group 3: single file reciprocal motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study startSep 2016
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Firat Eyuboglu, Istanbul Medipol University Hospital
- Investigators
- TAN FIRAT EYUBOGLU, DDS, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478241
- Sponsor's protocol ID
- 481
- Status last verified
- Mar 2018
- First submitted
- 14 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03478241
- Acronym / sponsor ID
- 481
- Conditions
- Pain, Postoperative, Endodontically Treated Teeth
- Keywords
- Endodontic retreatment, postoperative pain, OneShape, Revo-S, WaveOne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: single file rotary motion | Active comparator | Device: Group 1: single file rotary motionafter the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using OneShape Ni-Ti system. |
| Group 2: multiple file rotary motion | Active comparator | Device: Group 2: multiple file rotary motionafter 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 3: single file reciprocal motion | Active comparator | Device: Group 3: single file reciprocal motionafter the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using WaveOne Ni-Ti system. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Asymptomatic teeth
- Patients with no contradictory medical history
- Patients who were indicated for non-surgical retreatment and
- Patients who were above 18 years old
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1: single file rotary motionAlso: OneShapeafter 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 | Device | Group 1: single file rotary motion |
| Group 2: multiple file rotary motionAlso: Revo Safter 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 | Device | Group 2: multiple file rotary motion |
| Group 3: single file reciprocal motionAlso: WaveOneafter 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 | Device | Group 3: single file reciprocal motion |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TAN FIRAT EYUBOGLU, DDS, PhD principal investigator
Medipol University
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: single file rotary motion, Group 2: multiple file rotary motion and Group 3: single file reciprocal motion in people with Pain, Postoperative and Endodontically Treated Teeth, run by Istanbul Medipol University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.