Trial Outcomes & Findings for Orthodontic Patient Experience of Intraoral Scans Versus Alginate Impressions (NCT NCT05194956)
NCT ID: NCT05194956
Last Updated: 2025-03-18
Results Overview
A 100mm modified Visual Analogue Scale (VA scale) measuring patient comfort during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience. Minimum value: 0, Maximum value: 100
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
Immediately following intervention
Results posted on
2025-03-18
Participant Flow
Participant milestones
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
|---|---|---|
|
Period 1
STARTED
|
42
|
44
|
|
Period 1
COMPLETED
|
42
|
44
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
42
|
44
|
|
Washout Period
COMPLETED
|
42
|
42
|
|
Washout Period
NOT COMPLETED
|
0
|
2
|
|
Period 2
STARTED
|
42
|
42
|
|
Period 2
COMPLETED
|
42
|
42
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
|---|---|---|
|
Washout Period
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Orthodontic Patient Experience of Intraoral Scans Versus Alginate Impressions
Baseline characteristics by cohort
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
n=42 Participants
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
n=42 Participants
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.3 years
STANDARD_DEVIATION 4.23 • n=5 Participants
|
14.1 years
STANDARD_DEVIATION 3.10 • n=7 Participants
|
14.2 years
STANDARD_DEVIATION 3.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Pakistani
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Mixed heritage
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Indian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black African
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black Caribbean
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not given
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
42 participants
n=5 Participants
|
42 participants
n=7 Participants
|
84 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately following interventionA 100mm modified Visual Analogue Scale (VA scale) measuring patient comfort during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience. Minimum value: 0, Maximum value: 100
Outcome measures
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
n=42 Participants
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
n=42 Participants
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
|---|---|---|
|
Orthodontic Patient Comfort
|
9.2 score on a scale
Interval 2.46 to 15.97
|
7.7 score on a scale
Interval 0.87 to 14.51
|
SECONDARY outcome
Timeframe: Immediately following interventionA 100mm modified Visual Analogue Scale (VA scale) measuring pain during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience. Minimum value: 0, Maximum value: 100
Outcome measures
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
n=42 Participants
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
n=42 Participants
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
|---|---|---|
|
Experience of Pain
|
-3.5 score on a scale
Interval -10.75 to 3.71
|
-3.3 score on a scale
Interval -8.31 to 1.76
|
SECONDARY outcome
Timeframe: Immediately following interventionA 100mm modified Visual Analogue Scale (VA scale) measuring relative speed during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience. Minimum value: 0, Maximum value: 100
Outcome measures
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
n=42 Participants
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
n=42 Participants
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
|---|---|---|
|
Relative Speed of Impression
|
-3.5 score on a scale
Interval -8.01 to 1.11
|
-3.4 score on a scale
Interval -8.29 to 1.58
|
SECONDARY outcome
Timeframe: Immediately following interventionA 100mm modified Visual Analogue Scale (VA scale) measuring nausea and/or coughing during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience. Minimum value: 0, Maximum value: 100
Outcome measures
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
n=42 Participants
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
n=42 Participants
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
|---|---|---|
|
Nausea and/or Coughing
|
12.6 score on a scale
Interval 1.51 to 23.73
|
6.7 score on a scale
Interval -5.66 to 18.99
|
SECONDARY outcome
Timeframe: Immediately following interventionA 100mm modified Visual Analogue Scale (VA scale) measuring likely recommendation and/or coughing during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience. Minimum value: 0, Maximum value: 100
Outcome measures
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
n=42 Participants
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
n=42 Participants
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
|---|---|---|
|
Likely Recommendation
|
6.4 score on a scale
Interval 0.22 to 12.66
|
4.1 score on a scale
Interval -1.74 to 9.96
|
SECONDARY outcome
Timeframe: Immediately following interventionA 100mm Visual Analogue Scale (VA scale) measuring ease of impression for the operator during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience. Minimum value: 0, Maximum value: 100
Outcome measures
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
n=42 Participants
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
n=42 Participants
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
|---|---|---|
|
Ease of Impression for the Operator
|
-1.6 score on a scale
Interval -11.8 to 8.56
|
-8.8 score on a scale
Interval -15.06 to -2.56
|
SECONDARY outcome
Timeframe: Immediately following interventionA 100mm Visual Analogue Scale (VA scale) measuring operator confidence during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience. Minimum value: 0, Maximum value: 100
Outcome measures
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
n=42 Participants
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
n=42 Participants
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
|---|---|---|
|
Confidence Taking the Impression for the Operator
|
-1.9 score on a scale
Interval -6.2 to 2.39
|
-2.6 score on a scale
Interval -6.73 to 1.59
|
SECONDARY outcome
Timeframe: Immediately following interventionA 100mm Visual Analogue Scale (VA scale) measuring relative speed of impression for the operator during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience. Minimum value: 0, Maximum value: 100
Outcome measures
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
n=42 Participants
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
n=42 Participants
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
|---|---|---|
|
Relative Speed of Impression for the Operator
|
-8.1 score on a scale
Interval -21.93 to 5.72
|
-14.2 score on a scale
Interval -27.2 to -1.8
|
SECONDARY outcome
Timeframe: Immediately following interventionA 100mm Visual Analogue Scale (VA scale) measuring operator experience of sickness or coughing during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more positive experience. Minimum value: 0, Maximum value: 100
Outcome measures
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
n=42 Participants
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
n=42 Participants
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
|---|---|---|
|
Operator Experience of Sickness or Coughing
|
-26.9 score on a scale
Interval -38.5 to -15.24
|
-19.6 score on a scale
Interval -29.38 to -9.81
|
SECONDARY outcome
Timeframe: Immediately following interventionA quantitative time measure will be recorded for each impression method
Outcome measures
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
n=42 Participants
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
n=42 Participants
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
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|---|---|---|
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Chairside Time Taken to Complete Impression Method
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-88.8 seconds (within-patient)
Interval -136.62 to -41.04
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-151.1 seconds (within-patient)
Interval -185.38 to -116.81
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SECONDARY outcome
Timeframe: Immediately following completion of participant data collectionPopulation: This involved asking the 4 operators (clinicians) their overall preference for alginate impressions or intraoral scans during the clinical trial.
A simple question to determine operator preference for intraoral scanning versus alginate impressions.
Outcome measures
| Measure |
Arm 1 - Alginate Impressions Followed by Digital Intraoral Scan
n=4 Participants
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
Arm 2 - Digital Intraoral Scan Followed by Alginate Impressions
n=4 Participants
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.
Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.
|
|---|---|---|
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Operator Preference
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3 Participants
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1 Participants
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Adverse Events
Alginate Impression
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intraoral Scan
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
Mrs Trishna Patel
University Hospitals of Derby and Burton NHS Trust
Phone: 01332340131
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place