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Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects

NCT00001211 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2008-03-04

No results posted yet for this study

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

Conditions

  • Ectodermal Dysplasia
  • Jaw, Edentulous

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    lead NIH

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1986-01-31
Completion
2000-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001211 on ClinicalTrials.gov