Nighttime vs Daytime Clear Aligners
Recruiting in Palo Alto (17 mi)
+11 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Dentsply Sirona Implants and Consumables
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this research study is to see if Nighttime Aligners (worn 10-12 hours per day or night) are effective and safe for tooth movement and if so, how they compare with the standard Daytime aligners (worn 20-22 hours per day), in adults and children from 12 years of age and older.
It will investigate the efficacy and performance of the treatments, as well as the safety of the investigational device and comparator.
The main objectives are:
* Comparison between the two groups concerning actual vs planned tooth movements (measured by changes in tooth position)
* Comparison between the two groups concerning the incidence of device or dental related AEs.
* Overall dentist and participant satisfaction with the treatment.
Participants will:
* Be given orthodontic aligner therapy with the Daytime (20-22h/day) or Nighttime (10-12h/day) Aligners (randomly assigned)
* Attend approximately 5 study during approximately 8-10 months
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the study focuses on orthodontic aligners, it's unlikely that most medications would interfere. It's best to discuss your specific medications with the study team.
What data supports the idea that Nighttime vs Daytime Clear Aligners is an effective treatment?
The available research does not provide any data on the effectiveness of Nighttime vs Daytime Clear Aligners. The studies focus on topics like school performance, sleep patterns, and circadian preferences, but do not mention clear aligners or their effectiveness as a treatment.
12345What safety data exists for clear aligners?
Safety data for clear aligners, including direct-to-consumer (DTC) options, is available from the FDA's MAUDE database. Reports indicate adverse events such as bite problems, orofacial pain, and periodontal issues, especially when used without dental supervision. A study found 104 reports related to DTC aligners, with common issues being bite problems (41.3%), pain (29.8%), and periodontal sequelae (26.6%).
678910Eligibility Criteria
This trial is for adults and children aged 12 or older with permanent teeth, needing mild dental corrections without prior orthodontic treatment in the last 18 months. Participants should not have severe crowding/spacing (>5mm), need molar position corrections, or have plastic allergies. They must understand the study and consent to participate.Inclusion Criteria
I haven't had braces or any orthodontic treatment in the last 18 months.
I am 12 years old or older.
I am willing and able to participate in the study.
+7 more
Participant Groups
The study compares two types of aligners: Nighttime Aligners worn for 10-12 hours a night versus standard Daytime Aligners worn for 20-22 hours a day. It will assess how well each aligner moves teeth compared to planned movements, any device-related side effects, and satisfaction levels.
2Treatment groups
Experimental Treatment
Active Control
Group I: Nighttime AlignersExperimental Treatment1 Intervention
Nighttime Aligners worn 10-12 hours per day or night
Group II: Daytime AlignersActive Control1 Intervention
Daytime aligners worn 20-22 hours day and night
Daytime Aligners is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Invisalign for:
- Mild to severe tooth misalignment
- Overcrowding
- Gaps between teeth
- Overbites
- Underbites
🇺🇸 Approved in United States as Invisalign for:
- Mild to severe tooth misalignment
- Overcrowding
- Gaps between teeth
- Overbites
- Underbites
🇨🇦 Approved in Canada as Invisalign for:
- Mild to severe tooth misalignment
- Overcrowding
- Gaps between teeth
- Overbites
- Underbites
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fulbright DentalRedondo Beach, CA
3D DentalMiami Beach, FL
Cedars Family DentalPlainville, MA
R. Lobato & AssociatesLas Vegas, NV
More Trial Locations
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Who Is Running the Clinical Trial?
Dentsply Sirona Implants and ConsumablesLead Sponsor
References
Better Nights/Better Days-Distance Intervention for Insomnia in School-Aged Children With/Without ADHD: A Randomized Controlled Trial. [2019]Better Nights/Better Days, a distance intervention for insomnia in school-aged children (with and without attention-deficit/hyperactivity disorder [ADHD]), was evaluated to determine its effectiveness on children's sleep and psychosocial functioning.
Health-related quality of life in adolescent chronotypes--a model for the effects of sleep problems, sleep-related cognitions, and self-efficacy. [2015]In adolescence, the circadian preference shifts toward eveningness orientation. Eveningness seems to be negatively correlated with quality of life. The present study investigates influencing factors of this association and proposes a model for the mediating effects of sleep, sleep-related cognitions, and self-efficacy according to chronotype. The sample comprised N = 280 adolescents (172 girls) aged 14-16 yrs (mean = 15.19, SD = .76). Circadian preference, health-related quality of life (HRQoL), sleep disturbances, sleep-related dysfunctional cognitions, and general perceived self-efficacy were assessed online. Morning-orientated adolescents reported significantly higher HRQoL and less insomnia symptoms compared with evening-oriented chronotypes. In the total sample, insomnia symptoms mediated the relationship of chronotype and HRQoL. The strongest predictor of HRQoL in evening types was the degree of sleep-related dysfunctional cognitions. HRQoL in morning types was most strongly predicted by general self-efficacy, i.e., the global confidence in coping abilities. The findings support a negative relationship of eveningness and HRQoL in adolescents. Insomnia symptoms were identified to be mediating factors in this relationship. The influence of the mediating factors on HRQoL differed between morning and evening types. The model provides implications of how to enhance HRQoL in adolescents according to their circadian preference.
Circadian preference and academic achievement in school-aged students: a systematic review and a longitudinal investigation of reciprocal relations. [2021]We provide a systematic review of findings on the relation between circadian preference and school achievement published after the last comprehensive review in 2015. We further test this relation in a longitudinal study. Our review of 26 studies revealed a positive relation between morningness and students' school achievement, and a negative relation between eveningness and school achievement. In most studies, these relations were not affected by students' age, sex, or intelligence, but were significantly mediated by students' conscientiousness, motivation, and sleep behavior. Furthermore, circadian preference and school achievement showed no significant relation when school started in the afternoon. All studies were cross-sectional. Therefore, the direction of the relations between circadian preference, school achievement, and potential mediating variables like conscientiousness and motivation could not be investigated. In our longitudinal study, we tested the direction of the relations between circadian preference, academic achievement, conscientiousness, self-efficacy, and attitude toward school over time in a sample of 764 German high school students who were tested in the first (T1) and third (T2) year of high school. Findings from confirmatory cross-lagged models indicated reciprocal relations between circadian preference and school achievement: T1 morningness positively predicted change in grade point average over time while T1 grade point average positively predicted change in morningness and negatively predicted change in eveningness. Furthermore, T1 conscientiousness and T1 attitude toward school both positively predicted change in morningness, whereas T1 morningness and T1 eveningness did not significantly predict change in these variables.
Interaction between personal sleep-wake rhythms and psychiatric hospital rest-activity schedule. [2006]A sample of 35 psychiatric inpatients were matched on gender and psychiatric diagnosis with 35 psychiatric outpatients. Both groups were given the Self-Assessment Questionnaire to Determine Morningness-Eveningness (Horne & Ostberg, 1976), and asked to record their sleep-wake patterns on a modified form of the Lewis and Masterton Sleep Chart (1957). The purpose was to explore the interactions between individual circadian rhythms of sleep and wakefulness and the hospital's rest-activity schedule. As hypothesized, inpatients slept less than outpatients (p = less than .05), but the mean total sleep time of evening types was not different from morning types. Circadian type was a good predictor of times of falling asleep and awakening for outpatients but not for inpatients, whose schedules appeared to be phase shifted by the hospital's rest-activity schedule. It was concluded that the theory of interacting rhythms guiding the study requires reformulation and that further research regarding the positive or negative effects of phase shifting is needed.
School start times matter, eveningness does not. [2019]Morningness-Eveningness (M-E) has been associated with school performance when school activities are arranged early in the morning. This study aims to evaluate this association in 224 adolescents of a secondary school in Montevideo, Uruguay, attending either morning or afternoon shifts. Students' socio-demographic characteristics and performance indicators were similar across shifts, while afternoon-shift students exhibited later circadian preferences. After controlling for socio-demographic and other educational variables, eveningness was associated with lower grades only in morning-shift students. Our study suggests that eveningness influence on school performance is contingent on the temporal arrangement of scholar activities.
Adverse Events Related to Direct-To-Consumer Sequential Aligners-A Study of the MAUDE Database. [2023]Background-Direct-to-consumer (DTC) sequential aligners promote "teeth straightening" at a low cost and with added patient convenience. DTC sequential aligners have risen in popularity among the general public and sparked debate among dental professionals. Dental professionals argue that using these aligners without an in-person diagnosis and treatment planning protocol set by a licensed dentist or orthodontist may lead to adverse effects on teeth and surrounding structures. The objective of this study is to describe adverse clinical events associated with the use of DTC sequential aligners as reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (FDA MAUDE) database. Methods-We searched the MAUDE database from 1 January 2010 to 31 December 2020 for the product code of 'NXC' (sequential aligners). The year, type of adverse event, reporter occupation, and event description were noted. Results-651 reports associated with sequential aligners were found, of which 104 were related to DTC sequential aligners. Fifty-four adverse events were reported in 2019. From the event description, 41.3% comprised bite problems, 29.8% comprised orofacial pain, and 26.6% of patients had some form of periodontal sequelae. Furthermore, 69.2% of the patients followed up after an adverse event with a dentist not associated with DTC aligners. Conclusions-The use of DTC sequential aligners without dental supervision has led to oral health problems, as documented in the MAUDE database. Commonly reported adverse events include bite problems, pain, sensitivity, and periodontal disease, and some adverse events are irreversible.
3D Printing of Clear Orthodontic Aligners: Where We Are and Where We Are Going. [2020]Clear orthodontic aligners were developed at the end of the 1990s [...].
Analysis of adverse events with use of orthodontic sequential aligners as reported in the manufacturer and user facility device experience database. [2017]Sequential aligners (SAs) introduced about a decade ago, changed the practice of orthodontics as we knew it but the adverse events and reactions (AER) associated with SA is not known. The Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is a reliable database that has AERs reported. The manuscript attempts to review the AER associated with SA using the MAUDE database.
Periodontal health during orthodontic treatment with clear aligners and fixed appliances: A meta-analysis. [2022]Clear aligners have become increasingly popular because of their esthetics and comfort. The authors' aim in this systematic review was to compare periodontal health in patients undergoing orthodontic treatment with clear aligners with that of those undergoing orthodontic treatment with fixed appliances.
Treatment outcome with orthodontic aligners and fixed appliances: a systematic review with meta-analyses. [2022]The use of orthodontic aligners to treat a variety of malocclusions has seen considerable increase in the last years, yet evidence about their efficacy and adverse effects relative to conventional fixed orthodontic appliances remains unclear.
The predictability of expansion with Invisalign: A retrospective cohort study. [2022]Few studies have evaluated the predictability of expansion with Invisalign for the current SmartTrack material.
Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb Everolimus-Eluting fully bioresorbable vascular scaffold: optical coherence tomography assessment in the ABSORB cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). [2020]This study sought to describe the frequency and clinical impact of acute scaffold disruption and late strut discontinuity of the second-generation Absorb bioresorbable polymeric vascular scaffolds (Absorb BVS, Abbott Vascular, Santa Clara, California) in the ABSORB (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) cohort B study by optical coherence tomography (OCT) post-procedure and at 6, 12, 24, and 36 months.
Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. [2020]The thin-strut SYNERGY stent has an abluminal everolimus-eluting bioabsorbable polymer coating designed to facilitate vascular healing and reduce risk of stent thrombosis. In the multicenter, randomized EVOLVE II trial (The EVOLVE II Clinical Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion[s]), SYNERGY was noninferior to the durable polymer PROMUS Element Plus everolimus-eluting stent for the primary end point of 1-year target lesion failure. Longer-term clinical follow-up will support the relative efficacy and safety of SYNERGY.
Serial 3-Dimensional Optical Coherence Tomography Assessment of Jailed Side-Branch by Second-Generation Drug-Eluting Absorbable Metal Scaffold (from the BIOSOLVE-II Trial). [2020]Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is used for treating coronary lesions. However, the natural history of the jailed side-branch (SB) after DREAMS 2G implantation remains to be elucidated. The aim of this study is to investigate the effect of scaffold struts on jailed SBs as assessed by 3-dimensional (3D) optical coherence tomography (OCT) after implantation of DREAMS 2G. We enrolled the patients who received a DREAMS 2G implantation and where OCT was performed at postprocedure and 12-month follow-up in the BIOSOLVE-II trial. The area of the ostium of jailed SBs and number of compartments divided by scaffold struts were assessed by cut-plane analysis using 3D OCT. A total of 24 patients with 61 jailed SBs were analyzed in this study. The number of compartments was significantly decreased (postprocedure; 1.98 ± 0.84 vs 12 months; 1.10 ± 0.30, p <0.001) during the 12 months. Since most of the struts disappeared, the ostium area was increased in 62% of jailed SBs at 12 months, however, not significantly different from postprocedure (postprocedure; 0.74 [0.34 to 1.46] mm2 vs 12 months; 0.78 [0.41 to 1.68] mm2, p = 0.055). The number of compartments created by scaffold struts and branching angle at postprocedure had no effect on the changes of SB ostium area. DREAMS 2G has a favorable absorption process in the jailed SBs up to 12 months and may be considered as an optional therapy for treating lesions that involve SBs.
Comparison of neointimal coverage between durable-polymer everolimus-eluting stents and bioresorbable-polymer everolimus-eluting stents 1 year after implantation using high-resolution coronary angioscopy. [2020]We aimed to compare the coronary angioscopic appearance of neointimal coverage (NIC) over durable-polymer everolimus-eluting stents (XIENCE-EES) and bioresorbable-polymer everolimus-eluting stents (SYNERGY-EES) 1 year after implantation.