PulpitisNCT02566486
Postoperative Pain Intensity After Using Different Instrumentation Techniques: a Randomized Clinical Study
A study testing Reciprocating system and Rotational system in people with Pulpitis, run by Bulent Ecevit University.
Trial summary
Aim The aim of this clinical study was to evaluate the influence of the instrumentation techniques on the incidence and intensity of postoperative pain in single-visit root canal treatment. Methodology Ninety patients with single root/canal and non-vital pulps were included. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Pulpitis
- What is being tested?
- Reciprocating system and Rotational system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Oct 2014
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- asymptomatic and non-vital teeth associated with periapical lesions
Who cannot join
- vital tooth
About this study
Aim The aim of this clinical study was to evaluate the influence of the instrumentation techniques on the incidence and intensity of postoperative pain in single-visit root canal treatment.
Methodology Ninety patients with single root/canal and non-vital pulps were included. The patients were assigned into 3 groups according to root canal instrumentation technique used; the modified step-back (stainless-steel hand files, HF), reciprocal (WaveOne, WO), and rotational (ProTaper Next, PTN). Root canal treatment was carried out in a single visit and the severity of postoperative pain was assessed by 4-point pain intensity scale. All the participants were called through phone at 12, 24 and 48 h to obtain the pain scores. Data were analyzed by the Kruskal-Wallis test.
Read the detailed description
Overall, 90 patients who had asymptomatic and non-vital teeth associated with periapical lesions, were included to the study. All diagnosis and treatment procedures were performed by a single operator to eliminate or minimize individual variability in the treatment between clinicians. The patients were randomly stratified into 3 groups of 30 by coin toss. Allocation was done by a person other than the operator performing the root canal procedure. The patients were assigned into three equal groups according to instrumentation techniques used (n=30);
- The modified step-back technique (n=30): The canals were instrumented with a modified step-back technique using stainless-steel hand files (HF, Dentsply Maillefer, Ballaigues, Switzerland). The canals were prepared to a master apical size 02/40 with K files by using the balance force technique. Step back technique was performed by using K-files #45-55 to a master apical size 02/40 with K files. The step back technique was performed using K-files #45-55.
- Reciprocal technique (n=30): The canals were instrumented with a driven reciprocation motion, using WaveOne (WO, Dentsply Maillefer, Ballaigues, Switzerland) file having a size 40 and a taper of 0.06 slow in-and-out pecking motion according to the manufacturer's instructions. The flutes of the instrument were cleaned after 3 pecks.
- Rotational technique (n=30): The canals were instrumented using ProTaper Next (PTN, Dentsply Maillefer, Ballaigues, Switzerland) 06/40 file in the sequence X1, X2, X3, X4 at a rotational speed of 300 rpm and 200 g/cm torque according to the manufacturer's instructions. The instruments were used up to the working length.
After isolation and access cavity preparation, the initial working length was then determined with an electronic root canal measurement device (Root ZX mini; J. Morita, Tokyo, Japan). It was confirmed using periapical radiographs. During the instrumentation, a total of 10 ml of 5% NaOCl were used for irrigation. The irrigation needle (NaviTip 31ga needle; Ultradent, South Jordan, UT, USA) was placed as deep as possible into the canal without resistance until it was 1 mm short of the predetermined WL.The final irrigation was performed with 5% NaOCl, 17% EDTA, and 2% chlorhexidine.
The root canals were obturated with gutta-percha and a resin based sealer (AH26, De Trey Dentsply, Konstanz, Germany) using cold lateral compaction technique. A standardized master cone size #40.02 gutta-percha was fitted with tug back at the working length. The gutta-percha cone was lightly coated with sealer and slowly inserted into the canal. Cold lateral compaction with accessory gutta-percha cones size 15 was performed until these could not be introduced more than 5 mm into the root canal. All canals were shaped, cleaned, and obturated in a single-visit.
Although no systemic medication was prescribed, the patients were instructed to take mild analgesics (400 mg of ibuprofen), if they experienced pain. The assessment of postoperative pain was carried out at 12, 24, and 48 hours after initial appointment by one independent clinician blinded to the groups. All the participants were called by blinded operator through phone at 12, 24 and 48 h to obtain the pain scores using a 4-point pain intensity scale (Dalton Orstavik et al. 1998). The presence or absence of pain, or the appropriate degree of pain was recorded by using a 4-point pain intensity scale. The pain categories were as follows:
- no pain;
- slight pain (mild discomfort, need no treatment);
- moderate pain (pain relieved by analgesics);
- severe pain (pain and/or swelling not relieved by simple analgesics and required unscheduled visit).
- Conditions
- Pulpitis
- Being tested
- Reciprocating system, Rotational system
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reciprocating systemDevice
Also called WaveOne
Different root canal instrumentation systems
Rotational systemDevice
Also called ProTaper Next
Different root canal instrumentation systems
| Study group | Role | What they receive |
|---|---|---|
| Reciprocating system | Other | Waveone root canal instrumentation file Receives: Device: Reciprocating system |
| Rotational system | Other | ProTaper Next root canal instrumentation file Receives: Device: Rotational system |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-point pain intensity scale
Change from intensity of postoperative pain at 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersan Çiçek, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566486
- Sponsor's protocol ID
- 2013-27194235-03
- Status last verified
- Oct 2015
- First submitted
- 30 Sep 2015
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Intensity After Using Different Instrumentation Techniques: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT02566486
- Acronym / sponsor ID
- 2013-27194235-03
- Conditions
- Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 2 Oct 2015 (estimated)
- 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.
Aim The aim of this clinical study was to evaluate the influence of the instrumentation techniques on the incidence and intensity of postoperative pain in single-visit root canal treatment.
Methodology Ninety patients with single root/canal and non-vital pulps were included. The patients were assigned into 3 groups according to root canal instrumentation technique used; the modified step-back (stainless-steel hand files, HF), reciprocal (WaveOne, WO), and rotational (ProTaper Next, PTN). Root canal treatment was carried out in a single visit and the severity of postoperative pain was assessed by 4-point pain intensity scale. All the participants were called through phone at 12, 24 and 48 h to obtain the pain scores. Data were analyzed by the Kruskal-Wallis test.
Detailed description
Overall, 90 patients who had asymptomatic and non-vital teeth associated with periapical lesions, were included to the study. All diagnosis and treatment procedures were performed by a single operator to eliminate or minimize individual variability in the treatment between clinicians. The patients were randomly stratified into 3 groups of 30 by coin toss. Allocation was done by a person other than the operator performing the root canal procedure. The patients were assigned into three equal groups according to instrumentation techniques used (n=30);
- The modified step-back technique (n=30): The canals were instrumented with a modified step-back technique using stainless-steel hand files (HF, Dentsply Maillefer, Ballaigues, Switzerland). The canals were prepared to a master apical size 02/40 with K files by using the balance force technique. Step back technique was performed by using K-files #45-55 to a master apical size 02/40 with K files. The step back technique was performed using K-files #45-55.
- Reciprocal technique (n=30): The canals were instrumented with a driven reciprocation motion, using WaveOne (WO, Dentsply Maillefer, Ballaigues, Switzerland) file having a size 40 and a taper of 0.06 slow in-and-out pecking motion according to the manufacturer's instructions. The flutes of the instrument were cleaned after 3 pecks.
- Rotational technique (n=30): The canals were instrumented using ProTaper Next (PTN, Dentsply Maillefer, Ballaigues, Switzerland) 06/40 file in the sequence X1, X2, X3, X4 at a rotational speed of 300 rpm and 200 g/cm torque according to the manufacturer's instructions. The instruments were used up to the working length.
After isolation and access cavity preparation, the initial working length was then determined with an electronic root canal measurement device (Root ZX mini; J. Morita, Tokyo, Japan). It was confirmed using periapical radiographs. During the instrumentation, a total of 10 ml of 5% NaOCl were used for irrigation. The irrigation needle (NaviTip 31ga needle; Ultradent, South Jordan, UT, USA) was placed as deep as possible into the canal without resistance until it was 1 mm short of the predetermined WL.The final irrigation was performed with 5% NaOCl, 17% EDTA, and 2% chlorhexidine.
The root canals were obturated with gutta-percha and a resin based sealer (AH26, De Trey Dentsply, Konstanz, Germany) using cold lateral compaction technique. A standardized master cone size #40.02 gutta-percha was fitted with tug back at the working length. The gutta-percha cone was lightly coated with sealer and slowly inserted into the canal. Cold lateral compaction with accessory gutta-percha cones size 15 was performed until these could not be introduced more than 5 mm into the root canal. All canals were shaped, cleaned, and obturated in a single-visit.
Although no systemic medication was prescribed, the patients were instructed to take mild analgesics (400 mg of ibuprofen), if they experienced pain. The assessment of postoperative pain was carried out at 12, 24, and 48 hours after initial appointment by one independent clinician blinded to the groups. All the participants were called by blinded operator through phone at 12, 24 and 48 h to obtain the pain scores using a 4-point pain intensity scale (Dalton Orstavik et al. 1998). The presence or absence of pain, or the appropriate degree of pain was recorded by using a 4-point pain intensity scale. The pain categories were as follows:
- no pain;
- slight pain (mild discomfort, need no treatment);
- moderate pain (pain relieved by analgesics);
- severe pain (pain and/or swelling not relieved by simple analgesics and required unscheduled visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reciprocating system | Other | Device: Reciprocating systemWaveone root canal instrumentation file |
| Rotational system | Other | Device: Rotational systemProTaper Next root canal instrumentation file |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- asymptomatic and non-vital teeth associated with periapical lesions
Key exclusion criteria (1 listed)
- vital tooth
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 |
|---|---|---|
| Reciprocating systemAlso: WaveOneDifferent root canal instrumentation systems | Device | Reciprocating system |
| Rotational systemAlso: ProTaper NextDifferent root canal instrumentation systems | Device | Rotational system |
Primary outcome
4-point pain intensity scale
Time frame: 48 hours
Change from intensity of postoperative pain at 48 hours
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 2 Oct 2015.
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Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reciprocating system and Rotational system in people with Pulpitis, run by Bulent Ecevit University.
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 1 inclusion and 1 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 2 Oct 2015. 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?
4-point pain intensity scale (time frame: 48 hours). 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 2 Oct 2015.