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Protocol Details

Use of Clear Aligners for The Treatment of Dental Malocclusion in Individuals with Osteogenesis Imperfecta

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000350-D

Sponsoring Institute

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 12 Years
Max Age: 40 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Invisalign;
Oi;
Dentinogenesis;
Bone Disorder;
Dental Misalignment

Recruitment Keyword(s)

None

Condition(s)

Osteogenesis Imperfecta;
Dental Malocculsion

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Invisalign (clear aligner) system

Supporting Site

National Institute of Dental and Craniofacial Research

Background:

Osteogenesis imperfecta (OI) is a disorder of connective tissue that can cause brittle bones, resulting in frequent fractures and bone deformities. Severe OI can cause the teeth to misalign. It can also affect gum health, speech, and the ability to open the jaw, chew, and breathe. People with severe OI cannot be treated with dental braces because their teeth can crack or chip. Other solutions are needed.

Objective:

To test the use of clear dental aligners to fix misaligned teeth in people with severe OI.

Eligibility:

People aged 12 to 40 years with OI type III or IV who have misaligned teeth and no prior orthodontic treatment.

Design:

Participants will visit a clinic up to 15 times over 28 months.

Participants will undergo screening. They will have a dental exam. A camera wand and a special type of CT scan will be used to get images of their teeth and jaws.

Participants will return for a second exam in 2 months. They will chew a special piece of gum for 3 minutes.

After 4 months of observation, participants will begin treatment. They will receive clear aligners and be instructed in how to use them. They will wear the aligners day and night. They will remove the aligners only to eat, drink, and brush their teeth.

Participants will have follow-up visits every 2 months for up to 24 months. The dental exams will be repeated throughout the study.

People with OI who are not eligible for treatment with aligners may participate in a natural history group. They will return for dental exams after 6, 12, and 24 months.

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Eligibility

INCLUSION CRITERIA:

1. Clinical diagnosis of OI type III or IV.

2. Malocclusion of intermediate severity defined as a PAR score between 15 and 40.

3. Age range 12 to 40 years at the screening visit.

4. Presence of minimum number of intact teeth to proceed with orthodontic treatment.

EXCLUSION CRITERIA:

1. Prior orthodontic treatment defined as - any history of braces, palatal expansion or Invisalign treatment.

2. Candidates who meet the PAR score but would require surgical intervention for correction of malocclusion

3. Presence of impacted or retained teeth.

4. Use of medication, other than bisphosphonates, known to affect bone metabolism and contraindicated on orthodontic treatment, examples are, growth hormone,corticosteroids (chronic use) and thyroid hormones.

5. Presence of other dental, oral or systemic conditions that may interfere with orthodontic treatment. Examples are severe gingivitis, active periodontal disease, cancer.

6. Pregnancy - positive during screening visit.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Janice S. Lee, DDS, MD
National Institute of Dental And Craniofacial Research (NIDCR)
NIHBC 10 - CRC BG RM 5-2531
10 CENTER DR
BETHESDA MD 20892
(301) 827-1647
leejs2@mail.nih.gov

Danielle Elangue
National Institute of Dental And Craniofacial Research (NIDCR)
National Institutes of Health
Building 10
Room 1N103
10 Center Drive
Bethesda, Maryland 20892
(301) 451-9733
danielle.elangue@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04815564

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