Nighttime vs Daytime Clear Aligners

Recruiting at 11 trial locations

Overseen By AnnaKarin Lundgren

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Dentsply Sirona Implants and Consumables

Disqualifiers: Active carries, Periodontal disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8-10 months

7 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

What 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%). ^{6 7 8 9 10}

Is the treatment of Daytime Aligners and Nighttime Aligners a promising treatment?

The information provided does not include any relevant research articles about Daytime Aligners or Nighttime Aligners, so we cannot determine if they are a promising treatment based on this data. ^{11 12 13 14 15}

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

Research Team

Jay Khorsandi, Dr

Principal Investigator

BYTE

Eligibility 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orthodontic aligner therapy with either Daytime or Nighttime Aligners, randomly assigned

8-10 months

Approximately 5 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of satisfaction and adverse events

2-8 months

Treatment Details

Interventions

• Daytime Aligners
• Nighttime Aligners

Trial Overview 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.

Participant Groups

Group I: Nighttime Aligners Experimental Treatment 1 Intervention

Nighttime Aligners worn 10-12 hours per day or night

Group II: Daytime Aligners Active Control 1 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

Who Is Running the Clinical Trial?

Dentsply Sirona Implants and Consumables

Lead Sponsor

Trials

68

Recruited

4,800+

Simon Campion

Dentsply Sirona Implants and Consumables

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. Patrizia Cavazzoni

Dentsply Sirona Implants and Consumables

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

The 'Better Nights/Better Days' intervention significantly reduced sleep problems and improved psychosocial functioning in school-aged children, regardless of ADHD diagnosis, based on a randomized controlled trial with 61 participants.

Actigraphy data showed that while the intervention improved sleep onset, it did not affect sleep duration, indicating a targeted effect on how quickly children fall asleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better Nights/Better Days-Distance Intervention for Insomnia in School-Aged Children With/Without ADHD: A Randomized Controlled Trial. Corkum, P., Lingley-Pottie, P., Davidson, F., et al.[2019]

In a study of 280 adolescents aged 14-16, evening-oriented individuals reported lower health-related quality of life (HRQoL) and more insomnia symptoms compared to morning-oriented peers, highlighting a negative correlation between eveningness and overall well-being.

Insomnia symptoms were found to mediate the relationship between chronotype and HRQoL, with sleep-related dysfunctional cognitions being a strong predictor for evening types, while self-efficacy was a key predictor for morning types, suggesting tailored interventions could improve HRQoL based on circadian preference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life in adolescent chronotypes--a model for the effects of sleep problems, sleep-related cognitions, and self-efficacy. Roeser, K., Brückner, D., Schwerdtle, B., et al.[2015]

A systematic review of 26 studies found that students who prefer mornings tend to achieve better academically, while those who prefer evenings tend to perform worse, with these effects mediated by factors like conscientiousness and motivation.

In a longitudinal study of 764 German high school students, morningness was shown to positively influence academic performance over time, indicating a reciprocal relationship where better grades can also lead to a stronger morning preference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian preference and academic achievement in school-aged students: a systematic review and a longitudinal investigation of reciprocal relations. Scherrer, V., Preckel, F.[2021]

In a study of 70 psychiatric patients (35 inpatients and 35 outpatients), it was found that inpatients slept significantly less than outpatients, indicating that the hospital environment may disrupt normal sleep patterns.

Circadian type (morningness-eveningness) influenced sleep timing for outpatients but not for inpatients, suggesting that the hospital's rest-activity schedule may phase shift the natural sleep-wake rhythms of inpatients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction between personal sleep-wake rhythms and psychiatric hospital rest-activity schedule. Floyd, JA.[2006]

In a study of 224 adolescents in Montevideo, Uruguay, it was found that students who preferred evening activities (eveningness) had lower grades, but only when they attended morning classes.

The results suggest that the timing of school activities plays a crucial role in how eveningness affects academic performance, indicating that aligning school schedules with students' natural circadian preferences could improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School start times matter, eveningness does not. Estevan, I., Silva, A., Tassino, B.[2019]

A review of the FDA's MAUDE database revealed 104 adverse events associated with direct-to-consumer (DTC) sequential aligners, highlighting significant oral health issues such as bite problems (41.3%), orofacial pain (29.8%), and periodontal complications (26.6%).

The majority of patients (69.2%) sought follow-up care from dentists not affiliated with the DTC aligners, indicating that the lack of professional supervision during treatment can lead to serious and potentially irreversible dental problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Direct-To-Consumer Sequential Aligners-A Study of the MAUDE Database. Belgal, P., Mhay, S., Patel, V., et al.[2023]

Clear orthodontic aligners were introduced in the late 1990s as a modern alternative to traditional braces for teeth straightening.

These aligners offer a more aesthetic and comfortable option for patients, allowing for improved oral hygiene and easier removal during eating and cleaning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D Printing of Clear Orthodontic Aligners: Where We Are and Where We Are Going. Maspero, C., Tartaglia, GM.[2020]

Over a 5-year period, 175 adverse events and reactions (AERs) related to sequential aligners were reported in the FDA's MAUDE database, with a significant portion (73.71%) being mandatory reports from manufacturers.

Common AERs included allergic reactions (18.29%), with serious cases such as anaphylaxis (11.43%) and angioedema (2.29%), as well as other issues like gastrointestinal problems and neuromuscular symptoms, highlighting the need for awareness of potential risks associated with sequential aligner use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events with use of orthodontic sequential aligners as reported in the manufacturer and user facility device experience database. Thavarajah, R., Thennukonda, RA.[2017]

Clear aligners are associated with better periodontal health compared to fixed appliances, showing significant improvements in plaque index, gingival index, and probing depth based on a systematic review of 9 studies.

Despite the positive findings, the evidence quality was downgraded due to risks of bias and inconsistencies, indicating that further high-quality research is needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periodontal health during orthodontic treatment with clear aligners and fixed appliances: A meta-analysis. Jiang, Q., Li, J., Mei, L., et al.[2022]

A systematic review of 11 studies involving 887 patients found that orthodontic aligners resulted in worse occlusal outcomes compared to traditional braces, indicating they may not be as effective for comprehensive orthodontic treatment.

The evidence suggests that aligners lead to more patients experiencing unacceptable results, with a relative risk of 1.6, while treatment duration was similar between the two methods, highlighting that aligners may not be a suitable alternative to fixed appliances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment outcome with orthodontic aligners and fixed appliances: a systematic review with meta-analyses. Papageorgiou, SN., Koletsi, D., Iliadi, A., et al.[2022]

In a study of 57 adult patients using Invisalign for arch expansion, the predictability of achieving the planned expansion varied significantly by tooth type, with the highest predictability seen in mandibular first premolars (93.0%) and the lowest in maxillary second molars (41.5%).

Overall, the actual expansion achieved was often different from what was predicted, indicating that both underexpansion and overexpansion can occur, suggesting that clinicians should be cautious when planning treatment and consider potential inaccuracies in expansion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The predictability of expansion with Invisalign: A retrospective cohort study. Tien, R., Patel, V., Chen, T., et al.[2022]

Acute scaffold disruption occurred in only 3.9% of patients, indicating it is a rare complication associated with overexpansion during implantation, with minimal clinical impact as only one patient required revascularization.

Late strut discontinuity was observed in about 40% of patients, which is part of the normal bioresorption process of the scaffold and did not lead to major adverse cardiac events, suggesting it is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Onuma, Y., Serruys, PW., Muramatsu, T., et al.[2020]

The SYNERGY stent, designed with a bioabsorbable polymer coating, showed comparable effectiveness to the PROMUS Element Plus stent in preventing target lesion failure over a 5-year period, with rates of 14.3% for SYNERGY and 14.2% for PROMUS Element Plus.

Both stents had low rates of stent thrombosis (0.7% for SYNERGY and 0.9% for PROMUS Element Plus), indicating a strong safety profile, particularly in patients with diabetes, where SYNERGY maintained favorable outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. Kereiakes, DJ., Windecker, S., Jobe, RL., et al.[2020]

In a study of 24 patients with 61 jailed side-branches (SBs) after DREAMS 2G implantation, the number of compartments created by scaffold struts significantly decreased over 12 months, indicating a favorable absorption process of the scaffold.

After 12 months, the ostium area of jailed SBs increased in 62% of cases, suggesting that DREAMS 2G may effectively improve the condition of these side-branches, making it a potential option for treating complex coronary lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serial 3-Dimensional Optical Coherence Tomography Assessment of Jailed Side-Branch by Second-Generation Drug-Eluting Absorbable Metal Scaffold (from the BIOSOLVE-II Trial). Ozaki, Y., Garcia-Garcia, HM., Hideo-Kajita, A., et al.[2020]

In a study of 40 patients, SYNERGY-EES showed significantly better neointimal coverage (NIC) compared to XIENCE-EES, with 80% of SYNERGY-EES stents fully embedded in neointima after one year, indicating improved arterial healing.

The incidence of thrombi was lower in SYNERGY-EES (10%) compared to XIENCE-EES (40%), suggesting that SYNERGY-EES may have a safer profile regarding thrombus formation post-implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Nojima, Y., Adachi, H., Ihara, M., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Better Nights/Better Days-Distance Intervention for Insomnia in School-Aged Children With/Without ADHD: A Randomized Controlled Trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Health-related quality of life in adolescent chronotypes--a model for the effects of sleep problems, sleep-related cognitions, and self-efficacy. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Circadian preference and academic achievement in school-aged students: a systematic review and a longitudinal investigation of reciprocal relations. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Interaction between personal sleep-wake rhythms and psychiatric hospital rest-activity schedule. [2006]

5. England pubmed.ncbi.nlm.nih.gov

School start times matter, eveningness does not. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Direct-To-Consumer Sequential Aligners-A Study of the MAUDE Database. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

3D Printing of Clear Orthodontic Aligners: Where We Are and Where We Are Going. [2020]

8. India pubmed.ncbi.nlm.nih.gov

Analysis of adverse events with use of orthodontic sequential aligners as reported in the manufacturer and user facility device experience database. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Periodontal health during orthodontic treatment with clear aligners and fixed appliances: A meta-analysis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Treatment outcome with orthodontic aligners and fixed appliances: a systematic review with meta-analyses. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The predictability of expansion with Invisalign: A retrospective cohort study. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

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]

13. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

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]

15. United States pubmed.ncbi.nlm.nih.gov

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]