Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
Data Collection
Congenital Abnormalities+13
+ Abnormalities, Multiple
+ Jaw Diseases
Summary
Study start date: January 1, 1986
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.160 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Individuals with a need for replacement maxillary and mandibular complete dentures.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, United StatesOpen National Institute of Dental And Craniofacial Research (NIDCR) in Google Maps