NCT04277520

Brief Summary

The aim of this study is to evaluate postoperative pain after endodontic instrumentation using rotation, reciprocation and adaptive motion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

February 18, 2020

Last Update Submit

July 24, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • monitoring the change in postoperative pain following root canal treatment

    At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain

    72 hours

Secondary Outcomes (3)

  • 6-hour post operative pain assessment

    6 hours

  • 12-hour post operative pain assessment

    12 hours

  • 24-hour post operative pain assessment

    24 hours

Study Arms (3)

Continous rotation

ACTIVE COMPARATOR

instrumentation was done in continuous rotation motion

Procedure: Root canal therapy

Reciprocation

ACTIVE COMPARATOR

instrumentation was done in reciprocation motion

Procedure: Root canal therapy

Adaptive motion

ACTIVE COMPARATOR

instrumentation was done in adaptive motion

Procedure: Root canal therapy

Interventions

Different types of instrumentation motions during root canal therapy

Adaptive motionContinous rotationReciprocation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Medically free patients with good health.
  • Patient's age between 18\_50
  • Mandibular first molars teeth diagnosed clinically and radiographically as acute irreversible pulpitis with no evidence of apical pathosis
  • Positive patient's acceptance for participation in the study

You may not qualify if:

  • Root resorption
  • Non restorable teeth.
  • Pregnancy.
  • Systematic disease as hypertension ,diabetes .
  • Psychologically disturbance.
  • Need for prophylactic antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Ainshams University

Cairo, Egypt

Location

Related Publications (1)

  • Gambarini G, Testarelli L, De Luca M, Milana V, Plotino G, Grande NM, Rubini AG, Al Sudani D, Sannino G. The influence of three different instrumentation techniques on the incidence of postoperative pain after endodontic treatment. Ann Stomatol (Roma). 2013 Mar 20;4(1):152-5. doi: 10.11138/ads.0152. Print 2013 Jan.

    PMID: 23741536BACKGROUND

MeSH Terms

Interventions

Root Canal Therapy

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Officials

  • Ahmed Hashem, PhD

    Faculty of Dentistry, Ain Shams university

    STUDY DIRECTOR

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
Associate professor

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

February 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations