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Clinical Trial Details
A novel approach to integrate 3D facial and intraoral scans and its potential application in investigating soft tissue response in orthodontic treatment.
Clinical Trial ( IRB ) #: 24-204-2
Title: A novel approach to integrate 3D facial and intraoral scans and its potential application in investigating soft tissue response in orthodontic treatment.
Principal Investigator: Dr. Niloufar Azami
Description: Master Lay Summary: This research is being done to develop a new way to combine digital dental molds with 3D facial photos and therefore to investigate the facial soft tissue changes during orthodontic tooth movement at UConn Health/SODM. The digital dental molds will be obtained by providers using an intraoral scanner without ionizing radiation. At the same visit, the 3D facial photos will be taken by providers using a 3D camera system without radiation. The digital dental mold will be combined with 3D facial photos by two different methods: one method by using anterior dental landmarks as references, which is a published method; the other by using orthodontic arch wires as references, which is the one we proposed. Results from the two methods will be compared to test the reliability of the new method. To better understand how orthodontic tooth movement can affect the facial tissues (e.g., lips), researchers will repeat the same study procedures (both digital dental molds and 3D facial photos) at three consecutive orthodontic routine visits. After obtaining all the data, the researchers will combine all the images to investigate the relationship between tooth movement and soft tissue changes during these three orthodontic time points. Participants have braces fit to their teeth and anticipate some retraction of their front teeth as part of the orthodontic treatment plan. The only difference between the standard of care and this study is that participants will receive intraoral scans and facial scans during three orthodontic routine visits in addition to their regular treatment. The duration of the whole study for each participant can be up to 15-16 weeks. The study will begin from the time when participants receive retraction of their upper anterior teeth (front teeth) as part of their orthodontic treatment. Study visits will be scheduled on dates of routine orthodontic appointments with the addition of 15-20 minutes to each orthodontic appointment depending upon the sample collection procedures. The second study visit will be 4~7 weeks after the first study visit. The third study visit will be 12~15 weeks after the first one. The information to be collected by the researchers may lead to a better understanding of how orthodontic treatment can affect facial esthetics and therefore better esthetic results from orthodontic treatment in future. All those who participate in this study will receive standard care in the UConn Health/School of Dental Medicine Orthodontic clinic, which they may benefit from. Because of the research activities, there is a slight risk to you (your child) from participating in this research study (slightly more than braces treatment). Recording of the dental molds obtained with an intraoral digital scanner or recording of facial soft tissues with a hairband are slightly uncomfortable for some patients; you (your child) can take as much time as needed to complete these tasks on research visits. Research procedures will be conducted on the same day and place as your regular care for orthodontic treatment. Hypotheses, Aims, and Objectives: Hypothesis: Null Hypothesis Primary Outcome: develop a new method of combining digital dental molds with 3D facial photos. We hypothesize that there is no significant difference between the new method and the published method of combining digital dental molds with 3D facial photos. Secondary Outcome: investigate the correlation between orthodontic tooth movement and facial soft tissue changes during orthodontic treatment. We hypothesize that there is no correlation between orthodontic tooth movement and facial soft tissue changes during the study visits. Alternative Hypothesis There is a significant difference between the two methods of combining digital dental molds and 3D facial photos. There is a relationship between orthodontic tooth movement and facial soft tissue changes during the study visits. Aims/objectives: To compare the two methods of combining dental molds with 3D facial photos. To investigate the relationship between orthodontic tooth movement and facial soft tissue changes during the treatment.
Classification:
  Dental, Including Mouth
Eligibility Criteria: Check with study contact
How to Contact: Thais M.F. Fernandes Poleti. Telephone: 860-679-1876. Email: fernandespoleti@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.