NCT06116487

Brief Summary

Aim of this prospective study is to compare magnetic resonance imaging (MRI) and cone beam computed tomography (CBCT) to diagnose furcation involvement (FI) in molars in patients with periodontitis. The focus is on the differentiation of grad II and III according to Hamp et al. 1975. 140 molars (70 upper and 70 lower) will be investigated with CBCT and MRI. Due to the absence of ionic radiation MRI might be a radiation free diagnostic tool to assess FI in the future without harmful radiation for the patient. Patients of the Dental Clinic, Medical University of Vienna, who need a CBCT and have a clinically diagnosed FI can be a participant of this clinical trial and do in addition to their CBCT a MRI. The accuracy of MRI will be compared to the diagnostic gold standard CBCT. If patients need additional periodontal treatment, e.g., periodontal surgery, a subgroup will also be analysed with intraoperative measurements.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

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 25, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 25, 2023

Last Update Submit

October 31, 2023

Conditions

PeriodontitisPeriodontal DiseasesFurcation Defects

Keywords

CBCTMRIFurcation involvement

Outcome Measures

Primary Outcomes (1)

  • horizontal furcation defects according to Hamp 1975

    Grad 0, I, II, III

    day 1

Secondary Outcomes (2)

  • horizontal bone loss

    day 1

  • vertical bone loss

    day 1

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with clinical detected furcation involvement at the first or second molars

You may qualify if:

  • Patients with FI grade II or III, patients who need a CBCT, not pregnant

You may not qualify if:

  • Patients with contraindications to perform a MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Clinic of Dentistry

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

PeriodontitisPeriodontal DiseasesFurcation Defects

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Central Study Contacts

Elias Salzmann

CONTACT

0043 1 40070 4720elias.salzmann@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2023

First Posted

November 3, 2023

Study Start

November 20, 2023

Primary Completion

September 20, 2024

Study Completion

December 20, 2024

Last Updated

November 3, 2023

Record last verified: 2023-10

Locations

AU(1)