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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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:

  1. no pain;
  2. slight pain (mild discomfort, need no treatment);
  3. moderate pain (pain relieved by analgesics);
  4. 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 groups in NCT02566486
Study groupRoleWhat they receive
Reciprocating systemOtherWaveone root canal instrumentation file
Receives: Device: Reciprocating system
Rotational systemOtherProTaper 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.

  1. 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.

  1. First posted2 Oct 2015 (estimated)
  2. Study startNov 2013
  3. Primary completionDec 2013
  4. Study completionOct 2014

Resources

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)
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

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.

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