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Home > "C" Clinical Trials Conditions > Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects  Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
For Condition: Ectodermal Dysplasia,Jaw, Edentulous
Status: Completed
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: 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
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Individuals with a need for replacement maxillary and mandibular complete dentures.
Total Enrollment: 160
Location and Contact Information:
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 860015; 86-D-0015
Study Start Date: January 29, 1986
Record last reviewed: February 9, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001211
Other Ectodermal Dysplasia Studies:
1. Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
Related Studies:
Other Ectodermal Dysplasia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
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