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Status unknownNCT03285334Updated Sep 18, 2017

3D Instrumentation Versus Rotary Instrumentation

An interventional study of XP-endo Shaper and iRace files in Postoperative Pain, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study summary

enrollment of the patient after diagnosis, radiographic evaluation, and signing the informed consent.

allocation of the patient to either intervention or control group. After anaesthesia and access cavity, the first root canal sample will be taken. Endodontic treatment will be completed in one visit. The second root canal sample will be taken. Patients will be asked to evaluate their postoperative pain level using VAS scale at 6, 12, 24 hours, and daily up to 5 days. Patients will record the number of analgesics if any taken.

Read the detailed description

After diagnosing the case as asymptomatic pulp necrosis and confirming that the patient conforms to all eligibility criteria, (R.S) will enroll the patient in the study.

the operator will complete treatment of all cases in single visit as following:

  1. Anesthetizing the tooth using inferior alveolar nerve block technique
  2. Removal of Caries and/or coronal restorations completely with sterile bur and rubber dam will be applied.
  3. Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z bur .
  4. (R.S) will take the preinstrumentation root canal sample (S1)
  5. Confirming the patency of the root canals using stainless steel hand K-files size #10 and #15 . Working length will be determined .
  6. In the intervention group, (R.S) will perform mechanical preparation in a 3D manner using Xp-endo Shaper single file in an endodontic motor at a speed of 800 rpm and a torque of 1 Ncm.
  7. In the control group, mechanical preparation will be done using rotary iRace files (#25/0.04, #30/0.04, and #40/0.04) at a speed of 600 rpm and a torque of 1.5 Ncm. The canal will be irrigated and recapitulated after the use of each instrument.
  8. EDTA gel will be used as a lubricant. The canals will be thoroughly irrigated using 3ml of 2.5% sodium hypochlorite.
  9. The canal will then be dried by using sterile paper points and then flushed with 5 ml of 5% sodium thiosulfate to inactivate the NaOCl. The postinstrumentation sample (S2) will be taken from the canals.
  10. Master cones will be fitted to the working length and a radiograph will be taken to ensure proper length.
  11. (R.S) will complete obturation using AdSeal resin-based root canal sealer .
02

Conditions studied

  • Postoperative Pain

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03

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy Adult patients.
  2. Age between 20-40 years old.
  3. Males \& Females.
  4. Asymptomatic necrotic mandibular premolars with or without periapical radiolucency.
  5. Normal occlusal contact with the opposing teeth.
  6. Patients accepting to participate in the study.

Exclusion criteria

Exclusion criteria:

  1. Medically compromised patients
  2. Pregnant women
  3. If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively
  4. Patients reporting bruxism or clenching
  5. Teeth that shows:

    • Association with acute periapical abscess and swelling
    • Greater than grade I mobility or pocket depth greater than 5mm
    • No restorability
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    XP-endo Shaper

    The XP-endo Shaper is an innovative single instrument manufactured from Max wire. Its special ability to shift crystalline structure at body temperature in order to adapt to the root canal wall, has provided a unique instrument with the promise of anatomical shaping.

    Device: XP-endo Shaper

  • Active comparator
    iRace

    rotary files

    Device: iRace files

Interventions

  • DeviceXP-endo Shaper

    mechanical preparation in a 3D manner using Xp-endo Shaper

    Also known as: anatomical (3D) shaping file

  • DeviceiRace files

    rotary mechanical preparation

    Also known as: rotary files

05

What researchers measure

Primary outcomes

  1. Postoperative Pain

    Degree of postoperative pain will be measured by the patients using modified VAS

    Time frame: up to 5 days

Secondary outcomes

  1. intracanal bacterial reduction

    The intra-canal bacterial count will be determined using culture technique in the microbiological department, Cairo University. Samples in RTF vials will be dispersed with vortex for 30 seconds by the laboratory technician. The RTF solution will be serially diluted one-tenth dilution and spiral plated onto the agar medium. The plates will be incubated at 37ₒc aerobically and anaerobically. The resultant anaerobic growth will be quantified by evaluating the colony forming units (CFU) on the agar medium under the microscope and the number of CFU per milliliter of each dilution will be calculated for each sample.

    Time frame: 6 hours

  2. Incidence of analgesic intake

    In case of presence of moderate or severe postoperative pain, (R.S) will instruct the patients to take only one capsule of placebo given to him/her at the end of the visit (Powdered milk packed in opaque capsules)

    Time frame: up to 5 days

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03285334
Lead sponsor
Cairo University
Responsible party
Radwa Sameeh Emara (assisstant lecturer, Cairo University) — Principal investigator
First posted
Sep 18, 2017
Start date
Nov 2017 (estimated)
Primary completion
Feb 2018 (estimated)
Completion
Nov 2018 (estimated)
Last update
Sep 18, 2017

Study contacts

radwa emara
Contact
radwa.emara@dentistry.cu.edu.eg
01272141312
Radwa Emara
principal investigator · faculty of oral and dental medicine - cairo university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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