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Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001211
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: February 2000
  Purpose

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


Condition
Ectodermal Dysplasia
Jaw, Edentulous

Study Type: Observational
Official Title: Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 160
Study Start Date: January 1986
Estimated Study Completion Date: December 2000
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Individuals with a need for replacement maxillary and mandibular complete dentures.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001211

Locations
United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001211     History of Changes
Other Study ID Numbers: 860015, 86-D-0015
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Ectodermal Dysplasia
Edentulous
Endosseous
Implants
Mandibular Atrophy
Oral
Titanium

Additional relevant MeSH terms:
Ectodermal Dysplasia
Jaw, Edentulous
Mouth, Edentulous
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Jaw Diseases
Mouth Diseases
Musculoskeletal Diseases
Skin Abnormalities
Skin Diseases
Skin Diseases, Genetic
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on November 25, 2014