3D Instrumentation Versus Rotary Instrumentation | NCT03285334

Studies
3D Instrumentation Versus Rotary Instrumentation

NCT03285334

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Sep 18, 2017Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

XP-endo Shaper
iRace files

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2017Estimated

Primary Completion Date

Feb 2018Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

Sep 13, 2017

First Submission Date that Met QC Criteria

Sep 14, 2017

First Posted Date

Sep 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2017

Last Update Posted Date

Sep 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
XP-endo Shaper	Experimental	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
iRace	Active Comparator	rotary files	Device: iRace files

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XP-endo Shaper	Device	mechanical preparation in a 3D manner using Xp-endo Shaper	XP-endo Shaper

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative Pain	Degree of postoperative pain will be measured by the patients using modified VAS	up to 5 days

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
radwa emara	Contact	01272141312		radwa.emara@dentistry.cu.edu.eg

Overall Officials

Name	Affiliation	Role
Radwa Emara	faculty of oral and dental medicine - cairo university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Oral and Dental Medicine - Cairo University		Cairo	Manial	11553	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

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.

Who Masked

ParticipantOutcomes Assessor