NCT04689126

Brief Summary

this study will determine the effect of CBCT examinations on diagnostic and therapeutic decision making in endodontics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

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

November 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

1.4 years

First QC Date

December 11, 2020

Last Update Submit

December 25, 2020

Conditions

Keywords

resorptionfracturepulp necrosisnonendodontic diagnosis

Outcome Measures

Primary Outcomes (1)

  • Change in diagnosis and treatment planning

    Comparison of diagnostic and therapeutic decision making between gold standard and radiographic findings.

    1 year

Study Arms (1)

intervention

EXPERIMENTAL

diagnosis and treatment plan before and after cone beam computed tomography scan

Procedure: surgical or nonsurgical endodontic treatment

Interventions

Change in diagnosis and treatment plans between the two imaging - periapical radiography and cone beam computed tomography

Also known as: extraction, root amputation
intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in which disease had to be ruled out:
  • patients with symptomatic vital teeth otherwise judged healthy (no exposed dentin; normal sensitivity pulp tests; no tenderness to palpation or percussion; with radiographic apical/marginal periodontal normalcy; and no cracks/fractures)
  • patients with symptomatic root-filled teeth otherwise judged healthy (good quality of root filling that did not need to be revised or completed; no tenderness to palpation or percussion; with radiographic apical/marginal periodontal normalcy; and no cracks/fractures)
  • when conventional radiology failed to demonstrate if a finding was a pathological process or a normal anatomical structure.
  • Patients in which suspected disease had to be confirmed:
  • suspected dental fractures that could not be demonstrated
  • suspected external or internal resorptions.
  • As an aid in performing the therapeutic intervention:
  • in established external or internal resorptions to assist in the approach of complex cases
  • before apical surgery when important anatomical structures interfered with the surgical approach
  • in diagnosing foreign body structures, their location and, when needed, as a guide in the surgical removal
  • in understanding tooth anatomy of abnormal teeth in need of endodontic treatment
  • in assessing the number and location of root canals after at least one unsuccessful attempt to find them under oral microscope.

You may not qualify if:

  • Patients will not be referred for CBCT examination if they:
  • presented themselves with an accessible previous volume tomography in the region of interest. This was, however, not a strict restriction if the examiner judged that new and relevant information could be obtained by a new CBCT examination
  • had a definite diagnosis and treatment plan after a complete clinical and conventional radiographic examination and therefore did not need a CBCT examination. This group represented the vast majority of all patients
  • needed any other special imaging technique for soft tissue assessment such as CT or magnetic resonanace imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Science

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Fractures, BoneDental Pulp Necrosis

Interventions

Surgical Procedures, OperativeApicoectomy

Condition Hierarchy (Ancestors)

Wounds and InjuriesDental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresEndodonticsDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 30, 2020

Study Start

November 1, 2016

Primary Completion

March 30, 2018

Study Completion

April 30, 2018

Last Updated

December 30, 2020

Record last verified: 2020-12

Locations