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Necrotic PulpNCT03059290

Incidence of Post-Operative Pain After Single Visit Root Canal Treatment in Necrotic Teeth Using Two Different Rotary Systems (Protaper Nex t& Neolix File)

A study testing neolix file in people with Necrotic Pulp, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

this prospective in vivo randomized clinical is to evaluate the post operative pain (incidence ,degree and duration) with multiple full rotation file (protaper next ®) and single full rotation file (Neolix®) in treating maxillary and mandibular anterior and premolar with chronic pulpitis .Together with our aim from… Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Necrotic Pulp
What is being tested?
neolix file
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Mar 2017to 1 Dec 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 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Medically free patients.
  • Patient's age (20-65) years old.
  • Upper \&lower anterior and premolar teeth diagnosed clinically as necrotic teeth.
  • Positive patient's acceptance for participation in the study.
  • Sex includes both male and female.
  • Patients who can understand Numerical Rating Scale.
  • Patients able to sign informed consent.

Who cannot join

  • • Pregnancy or lactation.
  • Medically compromised patients.
  • Patient with multiple teeth that required treatment to eliminate the possibility of pain referral.

Trial locations and contacts

No sites are listed yet.

karim ahmed nahas, master degree candidate contact

+201006300519

karimnahas34@gmail.com

siza yacoub el zakhary, professor contact

+201006621083

siza.yacoub@dentistry.cu.edu.eg

About this study

this prospective in vivo randomized clinical is to evaluate the post operative pain (incidence ,degree and duration) with multiple full rotation file (protaper next ®) and single full rotation file (Neolix®) in treating maxillary and mandibular anterior and premolar with chronic pulpitis .Together with our aim from this trial ; we are trying to provide an evidence for the dentists in order to provide the best quality service with the least expenses and thus gaining the patients' trust and saving time, money and effort.

Read the detailed description

Interventions:

Using neolix file (Ori kam SAS,France)

Control:

Using Protaper next files (Dentsply ,Maillefer , Switzerland)

Treatment in all cases will be completed in one session as follows:

  • Full medical and dental history using a schematic dental chart will be obtained from all patients treated during this study. Each tooth will be evaluated for vitality (sensitivity) of pulp tissues using electric pulp tester (Kerr, Analytic Technology Crop, Redmond, WA).
  • Patient will be anesthetized; teeth will be isolated with rubber dam.
  • Make access and working length will be determined using an electronic apex locator (Root ZX, J.Morita USA, Irvine, CA.) then confirmed with intraoral periapical radiograph, to be 0.5-1 mm, shorter than radiographic apex.
  • Cleaning and shaping will be done using crown down preparation technique with rotary files either
  1. neolix file , first file used is C1 file size 25 taper 12% as orifice opener and for coronal flaring for 2/3 of canal length the A1 file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani ,Japan ) is loose or pass easily in the canal , but in case of K-file size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length to the full working length with (X-Smart, Dentsply Maillefer, USA.), with speed 300-500 rpm and torque 1.5 N.cm or
  2. protaper next in sequences by using Prepare straight line access to canal orifice. The ProTaper SX file may be used. Explore the canal using small-sized hand files, determine working length, verify patency and confirm a smooth, reproducible glide path. Always irrigate and if necessary, expand the glide path using small-sized hand files or dedicated mechanical glide path files. Path Files P1 and P2 are recommended. In the presence of NaOCl, brush and follow the glide path, with the PROTAPER NEXT™ X1 (017/04) file, in one or more passes until the working length is reached. Use PROTAPER NEXT X2 (025/06), exactly as described for PROTAPER NEXT X1 file, until the working length is passively reached. Gauge the foramen with a size 025 hand file and, if this file binds at length, the canal is shaped and ready for disinfection. If the size 025 hand file is loose at length, then continue shaping with the PROTAPER NEXT X3 (30/07) and, when necessary, the PROTAPER NEXT X4 (040/06) or PROTAPER NEXT X5 (050/06), gauging after each instrument with the 030, 040 or 050 hand files, respectively. During canal shaping, irrigate, recapitulate with a small-sized hand file after each sequential PROTAPER NEXT instrument, then re-irrigate. in an endodontic motor according to the manufacturer instructions (X-Smart, Dentsply Maillefer, USA.), with torque 2.0 N.cm and speed 300 rpm.
  • The rotary files will be introduced inside the canal using EDTA gel "MD-Chelcream, META BIOMED CO.,LTD, Korea".
  • The canals will be thoroughly irrigated using 3 ml of 2.5% Sodium hypochlorite between every subsequent instrument. After instrumentation of the canals, paper points will be used for drying.
  • Obturation will be carried out using gutta percha cones (25/0.6 or 40/0.4) Or Protaper next cones according to instrument used and canal size with resin sealer (ADSEAL, META BIOMED CO., LTD,Korea).After obturation a cotton pellet will be placed in the pulp chamber and the access cavity will be closed with a temporary filling to avoid coronal leakage. ((MD-Temp, META BIOMED CO., LTD, Korea).
  • The patient is given a Numerical Rating Scale and asked to rate his pain level at 6, 12, 24 \& 48 hours after obturation.
Conditions
Necrotic Pulp
Being tested
neolix file
Keywords
post operative pain, Post operative flare ups, Post endodontic pain, Post endodontic flare ups, Necrotic teeth, Non vital teeth, Neolix file, Single rotating file, Protaper next file, Multiple rotating file, Single visit
Medical subject headings
Dental Pulp Necrosis, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • neolix fileDevice

    first file used is C1 file size 25 taper 12% as orifice opener and for coronal flaring for 2/3 of canal length the A1 file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani ,Japan ) is loose or pass easily in the canal , but in case of K-file size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length to the full working length with (X-Smart, Dentsply Maillefer, USA.), with speed 300-500 rpm and torque 1.5 N.cm

Study groups in NCT03059290
Study groupRoleWhat they receive
protaper next fileActive comparatorthe PROTAPER NEXT™ X1 (017/04) file, in one or more passes until the working length is reached. Use PROTAPER NEXT X2 (025/06), exactly as described for PROTAPER NEXT X1 file, until the working length is passively reached. Gauge the foramen with a size 025 hand file and, if this file binds at length, the canal is shaped and ready for disinfection. If the size 025 hand file is loose at length, then continue shaping with the PROTAPER NEXT X3 (30/07) and, when necessary, the PROTAPER NEXT X4 (040/06) or PROTAPER NEXT X5 (050/06), gauging after each instrument with the 030, 040 or 050 hand files, respectively. During canal shaping, irrigate, recapitulate with a small-sized hand file after each sequential PROTAPER NEXT instrument, then re-irrigate. in an endodontic motor according to the manufacturer instructions (X-Smart, Dentsply Maillefer, USA.), with torque 2.0 N.cm and speed 300 rpm.
Receives: Device: neolix file

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation

    Measured: 6 hours

  2. the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation

    Measured: 12 hours

  3. the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation

    Measured: 24 hours

  4. the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation

    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 posted23 Feb 2017
  2. Study start1 Mar 2017 (estimated)
  3. Primary completion1 Nov 2017 (estimated)
  4. Study completion1 Dec 2017 (estimated)

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03059290
Sponsor's protocol ID
CEBC-CE-2017-01-15
Status last verified
Feb 2017
First submitted
12 Feb 2017
Last updated
23 Feb 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing neolix file in people with Necrotic Pulp, run by Cairo 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact karim ahmed nahas, master degree candidate (+201006300519, karimnahas34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation (time frame: 6 hours). The study lists 4 primary outcomes in all. 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 23 Feb 2017.

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