NCT05170477

Brief Summary

The aim of this clinical study is to evaluate the influence of apical patency concept implementation upon postoperative pain following root canal treatment in a single visit approach in molars with pulpal disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable postoperative-pain

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

September 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

November 27, 2021

Last Update Submit

March 14, 2022

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (4)

  • postoperative pain intensity using numerical rating scale

    postoperative pain after root canal treatment

    after 6 hours after root canal treatment

  • postoperative pain intensity using numerical rating scale

    postoperative pain after root canal treatment

    after12 hours after root canal treatment

  • postoperative pain intensity using numerical rating scale

    postoperative pain after root canal treatment

    after 24 hours after root canal treatment

  • postoperative pain intensity using numerical rating scale

    postoperative pain after root canal treatment

    after 48 hours after root canal treatment

Study Arms (2)

Apical aptency

EXPERIMENTAL

In Gp A, apical patency will be maintained till obturation using electronic apex locator confirmed radiographically

Procedure: apical patency

Non-apical patency

ACTIVE COMPARATOR

in Gp B apical patency will not be maintained

Procedure: Non-apical surgery

Interventions

apical patencyPROCEDURE

In Gp A, apical patency will be maintained till obturation using electronic apex locator confirmed radiographically. Finally, Root canals will be obturated using cold lateral compaction technique. The molars will be permanently restored using composite resin restoration and will be scheduled for extra coronal restoration.

Apical aptency
Non-apical surgeryPROCEDURE

in Gp B apical patency will not be maintained. Finally, Root canals will be obturated using cold lateral compaction technique. The molars will be permanently restored using composite resin restoration and will be scheduled for extra coronal restoration

Non-apical patency

Eligibility Criteria

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

You may qualify if:

  • 1. Patient age between 18-60 years old.
  • \. Both males and females will be included.
  • \. All patients are in a good health without systemic condition.
  • \. The offending tooth is a molar.
  • \. The offending molar is indicated for root canal treatment.
  • \. One molar for every patient.
  • \. All patients will sign an informed consent.

You may not qualify if:

  • \. The offending tooth has previous attempt of pulp therapy or root canal treatment.
  • \. The patient showing any clinical or radiographic evidence of periapical pathosis.
  • \. Patients received analgesics or systemic antibiotic prior to treatment.
  • \. Immunocompromised patients.
  • \. Any unknown infectious disease (e.g. HBV, HCV, HIV, or T.B.)
  • \. History of cancer with radio or chemotherapy.
  • \. Offending molar with mobility score ≥2.
  • \. Offending molar with pocket depth ≥6mm.
  • \. Immature molars.
  • \. Nonodontogenic pain.
  • \. Patients with more than one tooth requiring endodontic intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heba ahmed ElAsfouri

Giza, Dokki, 12611, Egypt

Location

Related Publications (1)

  • al-Omari MA, Dummer PM. Canal blockage and debris extrusion with eight preparation techniques. J Endod. 1995 Mar;21(3):154-8. doi: 10.1016/s0099-2399(06)80443-7.

    PMID: 7561660BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Heba A ElAsfouri, AssProfessor

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 27, 2021

First Posted

December 28, 2021

Study Start

September 30, 2021

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)