Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects - Tabular View

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	January 1986
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
Official Title ^ICMJE	Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
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 child's 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 child's assent to the study
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Ectodermal Dysplasia Jaw, Edentulous
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *	Guckes AD, Smith DE, Swoope CC. Counseling and related factors influencing satisfaction with dentures. J Prosthet Dent. 1978 Mar;39(3):259-67. No abstract available. Bolender CL, Swoope CC, Smith DE. The Cornell Medical Index as a prognostic aid for complete denture patients. J Prosthet Dent. 1969 Jul;22(1):20-9. No abstract available. Bergman B, Carlsson GE. Review of 54 complete denture wearers. Patients' opinions 1 year after treatment. Acta Odontol Scand. 1972 Oct;30(4):399-414. No abstract available.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	160
Completion Date	December 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	Individuals with a need for replacement maxillary and mandibular complete dentures.
Gender	Both
Ages
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001211
Responsible Party
Study ID Numbers ^ICMJE	860015, 86-D-0015
Study Sponsor ^ICMJE	National Institute of Dental and Craniofacial Research (NIDCR)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	February 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP