Trial Outcomes & Findings for Conventional Bite Wing Radiography Versus Stationary Intraoral Tomosynthesis, a Comparison Study (NCT NCT02873585)

Results Overview

This prospective study is to compare the diagnostic performance (accuracy) of a stationary intraoral tomosynthesis device using a Carbon Nanotube X-ray source array and a conventional intraoral X-ray device in the diagnosis of interproximal caries. receiver operating characteristic (ROC) analysis will be used to compare the areas under the curve (AUC).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Within 7 months of last participants imaging

Results posted on

2020-09-02

Participant Flow

Unit of analysis: Tooth surface

Participant milestones

Participant milestones
Measure	Stationary Intraoral Tomosynthesis Stationary intraoral tomosynthesis after standard conventional bitewing radiography Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit Standard conventional bitewing radiography: Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography
Overall Study STARTED	32 217
Overall Study COMPLETED	32 217
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Conventional Bite Wing Radiography Versus Stationary Intraoral Tomosynthesis, a Comparison Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stationary Intraoral Tomosynthesis n=217 Tooth Surfaces Stationary intraoral tomosynthesis after standard conventional bitewing radiography Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit Standard conventional bitewing radiography: Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography
Age, Categorical <=18 years	0 Participants n=32 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=32 Participants
Age, Categorical >=65 years	0 Participants n=32 Participants
Sex: Female, Male Female	20 Participants n=32 Participants
Sex: Female, Male Male	12 Participants n=32 Participants
Region of Enrollment United States	32 Participants n=32 Participants

PRIMARY outcome

Timeframe: Within 7 months of last participants imaging

This prospective study is to compare the diagnostic performance (accuracy) of a stationary intraoral tomosynthesis device using a Carbon Nanotube X-ray source array and a conventional intraoral X-ray device in the diagnosis of interproximal caries. receiver operating characteristic (ROC) analysis will be used to compare the areas under the curve (AUC).

Outcome measures

Outcome measures
Measure	Standard Conventional Bitewing Radiography n=217 Tooth Surfaces Bitewing radiographs using a standard two-dimensional bitewing radiography	Stationary Intraoral Tomosynthesis n=217 Tooth Surfaces Stationary intraoral tomosynthesis after standard conventional bitewing radiography. Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit
ROC Using the Area Under the Curve (AUC)	0.5427 probability Standard Deviation 0.0473	0.5173 probability Standard Deviation 0.0200

PRIMARY outcome

Timeframe: Within 7 months of last participants imaging

Specificity reflects the ability of the system to correctly identify healthy tooth surfaces expressed as a proportion.

Outcome measures

Outcome measures
Measure	Standard Conventional Bitewing Radiography n=217 tooth surfaces Bitewing radiographs using a standard two-dimensional bitewing radiography	Stationary Intraoral Tomosynthesis n=217 tooth surfaces Stationary intraoral tomosynthesis after standard conventional bitewing radiography. Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit
Proportion of Healthy Tooth Surfaces	0.7308 proportion of tooth surfaces Standard Deviation 0.099	0.7657 proportion of tooth surfaces Standard Deviation 0.045

PRIMARY outcome

Timeframe: Within 7 months of last participants imaging

Sensitivity reflects the ability of the system to correctly identify carious tooth surfaces expressed as a proportion.

Outcome measures

Outcome measures
Measure	Standard Conventional Bitewing Radiography n=217 tooth surfaces Bitewing radiographs using a standard two-dimensional bitewing radiography	Stationary Intraoral Tomosynthesis n=217 tooth surfaces Stationary intraoral tomosynthesis after standard conventional bitewing radiography. Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit
Proportion of Carious Tooth Surfaces	0.3601 proportion of carious tooth surfaces Standard Deviation 0.1006	0.2768 proportion of carious tooth surfaces Standard Deviation 0.0401

SECONDARY outcome

Timeframe: During a single 2-hour visit

Population: Responses reported for all that were received

Questionnaire used a five point Likert scale for evaluating participants' comfort with the experimental tomosynthesis unit (s-IOT) when compared to the standard intraoral unit used for bitewing radiography. Survey was distributed immediately after the examination using the experimental tomosynthesis unit. A score of 1 reflects "strongly disagree" and a score of 5 reflects "strongly disagree." A "positive experience" was defined as a score greater than 3.

Outcome measures

Outcome measures
Measure	Standard Conventional Bitewing Radiography n=32 Participants Bitewing radiographs using a standard two-dimensional bitewing radiography	Stationary Intraoral Tomosynthesis n=32 Participants Stationary intraoral tomosynthesis after standard conventional bitewing radiography. Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit
Number of Participants With a Positive Experience Equally Comfortable	13 Participants	19 Participants
Number of Participants With a Positive Experience More Comfortable	8 Participants	18 Participants
Number of Participants With a Positive Experience Requires More Time	6 Participants	25 Participants
Number of Participants With a Positive Experience Equally Easy to Perform	16 Participants	16 Participants
Number of Participants With a Positive Experience More Difficult to Perform	14 Participants	18 Participants
Number of Participants With a Positive Experience Noticeably Different	18 Participants	14 Participants
Number of Participants With a Positive Experience Recommended Without Reservation	27 Participants	5 Participants
Number of Participants With a Positive Experience Reported No Issues with Either System	18 Participants	10 Participants

SECONDARY outcome

Timeframe: During a single 2-hour visit

Population: This survey tool was not developed or executed; therefore, these data were not collected.

The investigators were to complete a brief survey regarding the overall confidence in diagnosis, time, and the number of required radiographic re-takes.

Outcome measures

Outcome data not reported

Adverse Events

Standard Conventional Bitewing Radiography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stationary Intraoral Tomosynthesis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Angela Broome, DDS, MS

University of North Carolina at Chapel Hill

Phone: 9195373160

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place