Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
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Purpose
The amendment to Clinical Protocol 86-D-0015, clinical study of Oral Endosseous Titanium Implants in Edentulous subjects, and patients with Ectodermal Dysplasia is to allow the Investigators to determine: (1) If placement of Endosseous Titanium Implants in pre-adolescent patients (age 7 to 10) will influence the growth and development of the craniomandibular complex. (2) The final position of the implant, the ability to fabricate prosthesis. (3) Body image, diet and perceived ease of chewing selected foods.
Selection of patients for participation in the study will be based on the number of congenitally missing teeth associated with Ectodermal Dysplasia. At least 16 permanent teeth must be congenitally missing. A total of 30 patients will be included.
A consent to participate in this study will be obtained from each patient:
18 & older - consent signed by patient
13-17 years - consent signed by parent, assent signed by patient
7-10 years - consent by parent, assent signed by child if capable of understanding or note on chart describing procedure used to obtain the child's assent to the study
| Condition |
|---|
|
Ectodermal Dysplasia Jaw, Edentulous |
| Study Type: | Observational |
| Official Title: | Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects |
| Estimated Enrollment: | 160 |
| Study Start Date: | January 1986 |
| Estimated Study Completion Date: | December 2000 |
The amendment to Clinical Protocol 86-D-0015, clinical study of Oral Endosseous Titanium Implants in Edentulous subjects, and patients with Ectodermal Dysplasia is to allow the Investigators to determine: (1) if placement of Endosseous Titanium Implants in pre-adolescent patients (age 7 to 10) will influence the growth and development of the craniomandibular complex. (2) The final position of the implant, the ability to fabricate prosthesis. (3) Body image, diet and perceived ease of chewing selected foods.
Selection of patients for participation in the study will be based on the number of congenitally missing teeth associated with Ectodermal Dysplasia. At least 16 permanent teeth must be congenitally missing. A total of 30 patients will be included.
A consent to participate in this study will be obtained from each patient:
18 & older - consent signed by patient
13-17 years - consent signed by parent, assent signed by patient
7-10 years - consent by parent, assent signed by child if capable of understanding or note on chart describing procedure used to obtain the child's assent to the study
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Individuals with a need for replacement maxillary and mandibular complete dentures.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00001211 History of Changes |
| Other Study ID Numbers: | 860015, 86-D-0015 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Ectodermal Dysplasia Edentulous Endosseous Implants |
Mandibular Atrophy Oral Titanium |
Additional relevant MeSH terms:
|
Ectodermal Dysplasia Jaw, Edentulous Mouth, Edentulous Abnormalities, Multiple Congenital Abnormalities Skin Abnormalities Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases Jaw Diseases Musculoskeletal Diseases Stomatognathic Diseases Mouth Diseases Tooth Diseases |
ClinicalTrials.gov processed this record on February 21, 2013
