Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001211
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
Status:
COMPLETED
Status Verified Date:
2000-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 childs assent to the study
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 childs assent to the study
Detailed Description:
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 childs assent to the study
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 childs assent to the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 86-D-0015 | None | None | None |