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Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
This study has been completed.
First Received: November 3, 1999   Last Updated: March 3, 2008   History of Changes
Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001211
  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:

Genetics Home Reference related topics: hypohidrotic ectodermal dysplasia
U.S. FDA Resources

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
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
National Institute of Dental and Craniofacial Research (NIDCR)
  More Information

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.

Study ID Numbers: 860015, 86-D-0015
Study First Received: November 3, 1999
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001211     History of Changes
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

Study placed in the following topic categories:
Mouth Diseases
Tooth Diseases
Skin Diseases
Skin Abnormalities
Mouth, Edentulous
Genetic Diseases, Inborn
Musculoskeletal Diseases
 Abnormalities, Multiple
Atrophy
Jaw, Edentulous
Stomatognathic Diseases
Congenital Abnormalities
Ectodermal Dysplasia
Skin Diseases, Genetic

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

ClinicalTrials.gov processed this record on July 02, 2009



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