NCT03338322

Brief Summary

assess the effect of using reciprocating motion with reciproc files versus adaptive motion using twisted file adaptive on postoperative pain after instrumentation of necrotic mandibular molars.

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
56

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2018

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

November 3, 2017

Last Update Submit

November 7, 2017

Conditions

Keywords

postoperative painreciproctwisted file adaptive

Outcome Measures

Primary Outcomes (1)

  • Post instrumentation pain

    post instrumentation pain will be recorded by the patient using numerical rating scale (0-10) will be used to record pain intensity

    up to 7 days

Secondary Outcomes (2)

  • analgesic intake

    up to 7 days

  • Colony forming units

    6 hours

Study Arms (2)

Twisted file adaptive

EXPERIMENTAL

Files that are used in root canal preparation in adaptive motion

Device: Twisted file adaptive

Reciproc

ACTIVE COMPARATOR

Reciproc files are used in root canal preparation with reciprocation motion

Device: Reciproc

Interventions

Endodontic files that are used in preparation of root canals with adaptive motion

Twisted file adaptive
ReciprocDEVICE

Endodontic files that are used in root canal preparation with reciprocation motion

Reciproc

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who are medically free from any systemic disease that may contraindicate our interventions.
  • Patient's age between 18-60 years old.
  • Mandibular molars having necrotic pulps with symptomatic or asymptomatic apical periodontitis because this group of patients may have more postoperative pain than vital teeth22.
  • Positive patient's acceptance for participation in the study.

You may not qualify if:

  • Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain after instrumentation.
  • Teeth with vital pulps or Symptomatic irreversible pulpitis.
  • Pregnant patients or lactating because of radiographic hazards and use of analgesics27.
  • Any known sensitivity or adverse reactions to ibuprofen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

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
Principal Investigator

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 9, 2017

Study Start

January 1, 2018

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

November 9, 2017

Record last verified: 2017-11