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3D Instrumentation Versus Rotary Instrumentation

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
XP-endo Shaper
iRace files
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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:

  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

Sites / Locations

  • Faculty of Oral and Dental Medicine - Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

XP-endo Shaper

iRace

Arm Description

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.

rotary files

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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)

Full Information

First Posted
September 13, 2017
Last Updated
September 14, 2017
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03285334
Brief Title
3D Instrumentation Versus Rotary Instrumentation
Official Title
The Effect of 3D Instrumentation Versus Rotary Instrumentation on Postoperative Pain and Bacterial Reduction in Necrotic Oval Canals: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2017 (Anticipated)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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: Anesthetizing the tooth using inferior alveolar nerve block technique Removal of Caries and/or coronal restorations completely with sterile bur and rubber dam will be applied. Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z bur . (R.S) will take the preinstrumentation root canal sample (S1) Confirming the patency of the root canals using stainless steel hand K-files size #10 and #15 . Working length will be determined . 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. 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. EDTA gel will be used as a lubricant. The canals will be thoroughly irrigated using 3ml of 2.5% sodium hypochlorite. 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. Master cones will be fitted to the working length and a radiograph will be taken to ensure proper length. (R.S) will complete obturation using AdSeal resin-based root canal sealer .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The patients will drag an envelope and will not know to which group they will be assigned. The patients who already do not know their treatment group will assess the level of their post-operative pain and will record the number of analgesic tablets used. The laboratory technician at the microbiological department will not know the treatment group of the patients.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XP-endo Shaper
Arm Type
Experimental
Arm Description
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.
Arm Title
iRace
Arm Type
Active Comparator
Arm Description
rotary files
Intervention Type
Device
Intervention Name(s)
XP-endo Shaper
Other Intervention Name(s)
anatomical (3D) shaping file
Intervention Description
mechanical preparation in a 3D manner using Xp-endo Shaper
Intervention Type
Device
Intervention Name(s)
iRace files
Other Intervention Name(s)
rotary files
Intervention Description
rotary mechanical preparation
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Degree of postoperative pain will be measured by the patients using modified VAS
Time Frame
up to 5 days
Secondary Outcome Measure Information:
Title
intracanal bacterial reduction
Description
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
Title
Incidence of analgesic intake
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Adult patients. Age between 20-40 years old. Males & Females. Asymptomatic necrotic mandibular premolars with or without periapical radiolucency. Normal occlusal contact with the opposing teeth. Patients accepting to participate in the study. Exclusion criteria: Medically compromised patients Pregnant women If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively Patients reporting bruxism or clenching Teeth that shows: Association with acute periapical abscess and swelling Greater than grade I mobility or pocket depth greater than 5mm No restorability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
radwa emara
Phone
01272141312
Email
radwa.emara@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radwa Emara
Organizational Affiliation
faculty of oral and dental medicine - cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine - Cairo University
City
Cairo
State/Province
Manial
ZIP/Postal Code
11553
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radwa Emara
Phone
01272141312
Email
radwa.emara@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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3D Instrumentation Versus Rotary Instrumentation

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