Trial Outcomes & Findings for A Comparison of the Accurate Diagnosis of the Horizontal & Vertical Bitewing Images (NCT NCT04341636)
NCT ID: NCT04341636
Last Updated: 2025-08-12
Results Overview
Count number of teeth with caries
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
baseline and 15 minutes
Results posted on
2025-08-12
Participant Flow
20 patients were screened for eligibility at the dental clinic
20 participants were randomized.
Participant milestones
| Measure |
Vertical Bitewing, Then Horizontal Bitewing
Participants first received vertical bitewing in one day for 15 minutes . After a washout period of 10 minutes, they then received horizontal bitewing in the same day for 15 minutes.
All of the bitewing radiographs will be evaluated by two experienced restorative dentists for caries. All observers will be instructed on the definition of the rating scale before the examination sessions. The observers will be using the following a 5-point confidence scale as follows: 1=caries definitely absent; 2=caries probably absent; 3=equal chance of caries being present or absent; 4=caries probably present; 5=caries definitely present. If caries was detected a second 5-point confidence scale as follows: 1=caries mostly absent (\< 25%); 2=caries slightly presence( 25%-50%) ; 3=about half of the border are presence; 4=caries probably clear ( most boarders are presence); 5=caries definitely clear ( all borders are presence ).
|
Horizontal Bitewing, Then Vertical Bitewing
Participants first received horizontal bitewing in one day for 15 minutes . After a washout period of 10 minutes, they then received vertical bitewing in the same day for 15 minutes.
All of the bitewing radiographs will be evaluated by two experienced periodontist for bone loss measurements. The steel wire will be used to determine the magnification factor as explained by G Li et al. 8 The steel wire and cemento enamel junction (CEJ) - if not obscure by caries - will be used as reference points for bone loss measurements. Each tooth will be measured mesially and distally twice and all these measurements will be adjusted using the steel measurement.9 All the measurements will be conducted using IC measure INK software.
|
|---|---|---|
|
First Intervention (15 Minutes)
STARTED
|
10
|
10
|
|
First Intervention (15 Minutes)
COMPLETED
|
10
|
10
|
|
First Intervention (15 Minutes)
NOT COMPLETED
|
0
|
0
|
|
Washout (10 Minutes)
STARTED
|
10
|
10
|
|
Washout (10 Minutes)
COMPLETED
|
10
|
10
|
|
Washout (10 Minutes)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (15 Minutes)
STARTED
|
10
|
10
|
|
Second Intervention (15 Minutes)
COMPLETED
|
10
|
10
|
|
Second Intervention (15 Minutes)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental: Vertical Bitewing, Then Horizontal Bitewing
n=10 Participants
Participants first received vertical bitewing. After a washout period of 15 min, they then received Horizontal bitewing.
|
Experimental: Horizontal Bitewing, Then Vertical Bitewing
n=10 Participants
Participants first received horizontal bitewing. After a washout period of 15 min, they then received vertical bitewing.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.05 Years
STANDARD_DEVIATION 9.79 • n=10 Participants
|
25.74 Years
STANDARD_DEVIATION 12.83 • n=10 Participants
|
29.9 Years
STANDARD_DEVIATION 11.6 • n=20 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
14 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Number of radiography
|
5.9 x ray
STANDARD_DEVIATION 1.7 • n=10 Participants
|
5.3 x ray
STANDARD_DEVIATION 1.3 • n=10 Participants
|
5.6 x ray
STANDARD_DEVIATION 1.5 • n=20 Participants
|
PRIMARY outcome
Timeframe: baseline and 15 minutesCount number of teeth with caries
Outcome measures
| Measure |
Vertical Bitewing
n=320 Teeth
Participants who received vertical bitewing in either the first or last 15 minutes of the study.
|
Horizontal Bitewing
n=320 Teeth
Participants who received horizontal bitewing in either the first or last 15 minutes of the study.
|
|---|---|---|
|
Caries Detection
|
7.22 teeth
Interval 6.0 to 8.44
|
6.48 teeth
Interval 5.24 to 7.72
|
PRIMARY outcome
Timeframe: baseline and at 15 minutesAll of the bitewing radiographs will be evaluated for bone loss measurements. The steel wire will be used to determine the magnification factor . The steel wire and cemento enamel junction (CEJ) - if not obscure by caries - will be used as reference points for bone loss measurements. Each tooth will be measured from the CEJ to the bone crest.
Outcome measures
| Measure |
Vertical Bitewing
n=320 Teeth
Participants who received vertical bitewing in either the first or last 15 minutes of the study.
|
Horizontal Bitewing
n=320 Teeth
Participants who received horizontal bitewing in either the first or last 15 minutes of the study.
|
|---|---|---|
|
Level of Bone Loss
|
1.15 mm of bone loss
Standard Deviation 0.69
|
1.12 mm of bone loss
Standard Deviation 0.63
|
Adverse Events
Vertical Bitewing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Horizontal Bitewing
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place