This study is currently recruiting participants.
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)
Condition(s)
Osteogenesis Imperfecta; Dental Malocculsion
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Other: Invisalign (clear aligner) system
Supporting Site
National Institute of Dental and Craniofacial Research
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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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.
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.
Principal Investigator
Referral Contact
For more information: