Trial Outcomes & Findings for A Study to Compare Nighttime Aligners to Daytime Aligners (NCT NCT06539676)
NCT ID: NCT06539676
Last Updated: 2025-07-16
Results Overview
Comparison between actual vs planned tooth movements, compared between the investigational treatment and the control device
TERMINATED
NA
7 participants
From day 0 (Treatment start) up to 8 months post treatment start (Final visit)
2025-07-16
Participant Flow
This study was terminated early. At time of study termination seven (7) subjects had been consented (started), out of which only one subject had been randomised and allocated a treatment arm (Treatment Start Visit). To report the six (6) subjects not yet assigned a treatment arm at time of early study termination, an additional Arm "Treatment Not assigned" was included.
Participant milestones
| Measure |
Nighttime Aligners
Nighttime Aligners worn 10-12 hours per day or night
Nighttime Aligners: Nighttime aligners worn 10-12 hours per day or night during 2-8 months
|
Daytime Aligners
Daytime Aligners worn 20-22 hours day and night
Daytime Aligners: Daytime aligners worn 20-22 hours per day or night during 2-8 months
|
Treatment Not Assigned
Subjects consented but where no treatment was assigned prior to early study termination.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
6
|
|
Overall Study
Treatment Start Visit
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
6
|
Reasons for withdrawal
| Measure |
Nighttime Aligners
Nighttime Aligners worn 10-12 hours per day or night
Nighttime Aligners: Nighttime aligners worn 10-12 hours per day or night during 2-8 months
|
Daytime Aligners
Daytime Aligners worn 20-22 hours day and night
Daytime Aligners: Daytime aligners worn 20-22 hours per day or night during 2-8 months
|
Treatment Not Assigned
Subjects consented but where no treatment was assigned prior to early study termination.
|
|---|---|---|---|
|
Overall Study
Early study termination
|
1
|
0
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Aligners
n=7 Participants
Either Nighttime Aligners worn 10-12 hours per day or night, or daytime aligners worn 20-22 hours day and night
|
|---|---|
|
Age, Continuous
|
32.4 Years
n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From day 0 (Treatment start) up to 8 months post treatment start (Final visit)Population: No subject conducted the final visit prior to early study termination. Consequently, no outcome data has been obtained in the study for this outcome and can thus not be presented.
Comparison between actual vs planned tooth movements, compared between the investigational treatment and the control device
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the final visit (2-8 months post day 0)Population: No subject conducted the final visit prior to early study termination. Consequently, no outcome data has been obtained in the study for this outcome and can thus not be presented.
Overall subject satisfaction with the treatment assessed by a questionnaire using a rating scale from 1 to 10 (1 very satisfied - 10 very unsatisfied).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the final visit (2-8 months post day 0)Population: No subject conducted the final visit prior to early study termination. Consequently, no outcome data has been obtained in the study for this outcome and can thus not be presented.
Overall dentist (investigator) satisfaction with the treatment assessed by a questionnaire using a rating scale from 1 to 10 (1 very satisfied - 10 very unsatisfied).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At each follow-up visit (Follow-up visits every 4-6 weeks post Day 0 during a 2-8 months period) and at the final visit (Day 0 + 2-8 months).Population: All subjects allocated a treatment arm (one subject in total).
The subject self-reported values pertaining to pain/discomfort during treatment and comfort in wearing the aligners captured in a questionnaire with Visual Analogue Scale (VAS) with a Wong Baker face scale (score 0-10), where a higher score corresponds to a higher level of pain/discomfort.
Outcome measures
| Measure |
Nighttime Aligners
n=1 Participants
Nighttime Aligners worn 10-12 hours per day or night
Nighttime Aligners: Nighttime aligners worn 10-12 hours per day or night during 2-8 months
|
Daytime Aligners
Daytime aligners worn 20-22 hours day and night
Daytime Aligners: Daytime aligners worn 20-22 hours per day or night during 2-8 months
|
|---|---|---|
|
Subject Self-reported Pain/Discomfort
Visit 1. Between this visit and the previous visit, how comfortable are the aligners to wear
|
9 score on a scale
Interval 9.0 to 9.0
|
—
|
|
Subject Self-reported Pain/Discomfort
Visit 2. Between this visit and the previous visit, how comfortable are the aligners to wear
|
9 score on a scale
Interval 9.0 to 9.0
|
—
|
|
Subject Self-reported Pain/Discomfort
Visit 3. Between this visit and the previous visit, how comfortable are the aligners to wear
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Subject Self-reported Pain/Discomfort
Visit 1. Pain associated with new tooth movement between this visit and the previous visit
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Subject Self-reported Pain/Discomfort
Visit 2. Pain associated with new tooth movement between this visit and the previous visit
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Subject Self-reported Pain/Discomfort
Visit 3. Pain associated with new tooth movement between this visit and the previous visit
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
Adverse Events
Nighttime Aligners
Daytime Aligners
Treatment Not Assigned
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nighttime Aligners
n=1 participants at risk
Nighttime Aligners worn 10-12 hours per day or night
Nighttime Aligners: Nighttime aligners worn 10-12 hours per day or night during 2-8 months
|
Daytime Aligners
Daytime Aligners worn 20-22 hours day and night
Daytime Aligners: Daytime aligners worn 20-22 hours per day or night during 2-8 months
|
Treatment Not Assigned
n=6 participants at risk
Subjects consented but where no treatment was assigned prior to early study termination.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Chipped bonding on a front tooth
|
100.0%
1/1 • Number of events 1 • From informed consent up to study termination (up to 4.5 months).
This study was terminated early. At time of study termination seven (7) subjects had been consented (started), out of which only one subject had been randomised and allocated a treatment arm (Treatment Start Visit). To report the six (6) subjects not yet assigned a treatment arm, an additional Arm "Treatment Not assigned" was included.
|
—
0/0 • From informed consent up to study termination (up to 4.5 months).
This study was terminated early. At time of study termination seven (7) subjects had been consented (started), out of which only one subject had been randomised and allocated a treatment arm (Treatment Start Visit). To report the six (6) subjects not yet assigned a treatment arm, an additional Arm "Treatment Not assigned" was included.
|
0.00%
0/6 • From informed consent up to study termination (up to 4.5 months).
This study was terminated early. At time of study termination seven (7) subjects had been consented (started), out of which only one subject had been randomised and allocated a treatment arm (Treatment Start Visit). To report the six (6) subjects not yet assigned a treatment arm, an additional Arm "Treatment Not assigned" was included.
|
Additional Information
Clinical Research Manager
Dentsply IH AB d.b.a Dentsply Sirona Implants
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60