Jaw, Edentulous Clinical Trial
Official title:
Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
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
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
;
N/A
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