NCT02940782

Brief Summary

A randomized clinical trial to assess postoperative pain in patients with symptomatic irreversible pulpitis after using Reciproc versus One Shape rotary NiTi Systems.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

October 19, 2016

Last Update Submit

October 19, 2016

Conditions

Pulpitis

Outcome Measures

Primary Outcomes (1)

  • Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10)

    Pain intensity after root canal treatment will be measured using Numerical Rating Scale (0-10)

    Immediately after treatment, then 6 hours, 12 hours, 24 hours and 72 hours after treatment.

Secondary Outcomes (1)

  • Number of analgesics taken by the patient

    72 hours from the end of the endodontic treatment

Study Arms (2)

Reciproc single file system

EXPERIMENTAL

It is a reciprocating NiTi file used for instrumentation of root canals in endodontic treatment

Procedure: Reciproc single file systemDevice: X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland

One Shape single file system

ACTIVE COMPARATOR

It is a rotary NiTi file used for instrumentation of root canals in endodontic treatment

Procedure: One Shape single file systemDevice: X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland

Interventions

Reciproc single file systemPROCEDURE

A reciprocating Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment.

Reciproc single file system
One Shape single file systemPROCEDURE

A rotary Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment.

One Shape single file system
X-smart Plus, Dentsply Maillefer, Ballaigues, SwitzerlandDEVICE

It is a micro-motor designed for performing root canal treatments with the reciprocating, single file technique or traditional continuous rotation file system.

One Shape single file systemReciproc single file system

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mandibular premolar teeth with:
  • Single canal
  • Preoperative sharp pain.
  • Vital response of pulp tissue.
  • Normal periapical radiographic appearance or slight widening in lamina dura.
  • Final diagnosis for an eligible patient will take place by radiograph and pulp testing.

You may not qualify if:

  • Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.
  • Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.
  • Pregnant females.
  • Patients having significant systemic disorder.
  • If antibiotics have been administrated during the past two weeks preoperatively.
  • Patients having bruxism or clenching.
  • Teeth that have:
  • Non-vital pulp tissues.
  • Association with swelling or fistulous tract.
  • A pocket depth greater than 5 mm.
  • Previous endodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Neelakantan P, Sharma S. Pain after single-visit root canal treatment with two single-file systems based on different kinematics--a prospective randomized multicenter clinical study. Clin Oral Investig. 2015 Dec;19(9):2211-7. doi: 10.1007/s00784-015-1448-x. Epub 2015 Mar 15.

    PMID: 25773449BACKGROUND

  • Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.

    PMID: 26614017BACKGROUND

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Ahmed A Soliman, B.D.S

    Faculty of Oral and Dental Medicine, Cairo University

    PRINCIPAL INVESTIGATOR

  • Angie G Ghoneim

    Faculty of Oral and Dental Medicine, Cairo University

    STUDY DIRECTOR

  • Shaimaa I Gawdat

    Faculty of Oral and Dental Medicine, Cairo University

    STUDY CHAIR

Central Study Contacts

Ahmed A Soliman, B.D.S

CONTACT

+20-01003564036aasoliman89@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Masters Candidate

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 21, 2016

Study Start

January 1, 2017

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

October 21, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share