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Orthodontic Treatment

Invisalign Wear Protocols for Orthodontic Treatment

N/A

Recruiting

Led By Sarah Abu Arqub, DDS

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 months

Awards & highlights

Study Summary

This trial aims to reduce the time for Invisalign aligners and increase predictability, accuracy and rate of tooth movement.

Who is the study for?

This trial is for healthy individuals aged 18-30 with moderate crowding of lower front teeth, needing Invisalign aligners. They must have good oral hygiene and no periodontal disease. People with previous orthognathic surgery, extraction treatment plans, poor oral hygiene, or craniofacial anomalies cannot participate.Check my eligibility

What is being tested?

The study tests if a new 3-day wear protocol for Invisalign aligners can move teeth more predictably and quickly than the standard 7-day protocol by applying less movement per aligner to maintain constant force on the teeth.See study design

What are the potential side effects?

Potential side effects may include discomfort or pain from tooth movement, irritation inside the mouth from the aligners, and possible temporary changes in bite alignment during treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

predictability of the different orthodontic tooth achieved in each of the studies groups movements achieved at the end of treatment in each of the studied groups (3-day wear vs 7-day wear).

rate of tooth movement for the lower anterior teeth as detected by the consecutive scans captured by the scan box (Dental Monitoring®) in the first 8 weeks of treatment

Secondary outcome measures

Occlusal outcomes

duration of treatment

number of refinements and visits needed for each wear protocol.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 2 (Experimental)Experimental Treatment1 Intervention

Group II: Group 1 (Control)Active Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,606 Total Patients Enrolled

Align Technology, Inc.Industry Sponsor

7 Previous Clinical Trials

1,022 Total Patients Enrolled

Sarah Abu Arqub, DDSPrincipal InvestigatorUniversity of Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation recruiting senior citizens?

"In order to be eligible for participation, individuals must fall within the age range of 18-30."

Answered by AI

Are there any open enrollment opportunities for this scientific trial?

"Based on the information hosted on clinicaltrials.gov, this medical study is not presently looking for participants as it was last updated in September 14th 2023. However, 3 other trials are currently recruiting patients for their research efforts."

Answered by AI

Are there certain eligibility criteria for partaking in this research endeavor?

"This trial seeks to recruit 40 individuals aged 18-30 with orthodontic treatments. To be eligible, participants must present as physically sound without any allergies or medical issues; have full permanent teeth except for third molars; display moderate crowding of lower anterior teeth (4-6mm according Little's Irregularity Index); possess excellent oral hygiene and lack periodontal disease; require Invisalign aligners (SmartTrack) for malocclusion correction; and belong to any ethnic group."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol on the Predictability of Orthodontic Tooth Movement

2023. "Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol on the Predictability of Orthodontic Tooth Movement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05905224.