NCT06149234

Brief Summary

Introduction: Panoramic radiography quality can be impaired by some errors such as positioning errors. Palatoglossal air space shadow error is one of the most common positioning errors and it's due to the tongue not sticking to the roof of the palate. Techniques used to deal with this error might help prevent unnecessary radiation to patients and save them time and money. The study aimed to investigate to investigate the effects of using celluloid matrix and edible tapes (fruit leather and chewing gum) on reducing the palatoglossal air space shadow error in panoramic imaging Methods: In our study, 270 patients referred to the Department of Radiology were randomised into three groups: a control group, a celluloid matrix group, and an edible tapes group. Before panoramic imaging, all patients were instructed to adhere their tongues to the roof of their mouths, with the distinction that for the celluloid matrix and edible tapes groups, patients were asked to place celluloid tapes, fruit leathers, or chewing gums on their tongues before doing so. The routine imaging process was then performed, and the results were compared across groups to evaluate the incidence of palatoglossal air space shadow error. Results: \*\*\* Conclusion: \*\*\*

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

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 29, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

November 14, 2023

Last Update Submit

November 28, 2023

Conditions

Keywords

Panoramic Radiography,Radiographic ErrorPatient PositioningDiagnostic ErrorPalatoglossal Airspace Error

Outcome Measures

Primary Outcomes (1)

  • Investigating the panoramic images

    Effect Of Using Different Strips On Reducing Palatoglossal Air Space Shadow: An oral and maxillofacial radiologist assessed the radiographs in single-blinded random selection to identify and record the errors. The radiographs were classified as diagnostically acceptable, unacceptable, and excellent based on the degree of the palatoglossal air space shadow error

    3 months

Study Arms (4)

Control Group

NO INTERVENTION

Normal panoramic positioning

Fruit leather on the tongue

EXPERIMENTAL

The patient holding a stripe of fruit leather on the tongue while acquiring a panoramic image

Behavioral: Fruit leather on the tongue

Chewing gum strip

EXPERIMENTAL

The patient holding a stripe of chewing gum on the tongue while acquiring a panoramic image

Behavioral: Chewing gum strip

Celluloid matrix group

EXPERIMENTAL

The patient holding a stripe of celluloid matrix group on the tongue while acquiring a panoramic image

Behavioral: Celluloid matrix group

Interventions

The patient holds a fruit leather strip on the tongue while being exposed.

Fruit leather on the tongue

The patient holds a banana-tasting gum strip on the tongue while being exposed.

Chewing gum strip

The patient holds a celluloid matrix stirp gum strip on the tongue while being exposed.

Celluloid matrix group

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients over 15 years old attending the oral and maxillofacial department and are already prescribed for panoramic imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tabriz University of Medical Sciences

Tabriz, Iran

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
An oral and maxillofacial radiologist assessed the radiographs in single-blinded random selection to identify and record the errors.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Kasra Rahimipour

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 28, 2023

Study Start

September 29, 2021

Primary Completion

February 20, 2022

Study Completion

March 20, 2022

Last Updated

December 4, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations