Otospondylomegaepiphyseal dysplasia |
Chondrodystrophy with sensorineural deafness; Insley-Astley syndrome; Mega-epiphyseal dwarfism; Nance-Insley syndrome; Nance-Sweeney chondrodysplasia; OSMED; Oto-spondylo-megaepiphyseal dysplasia |
Clinical Trial: Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
This study has been completed.
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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 |
MedlinePlus related topics: Birth Defects; Genetic Disorders; Mouth Disorders; Skin Diseases
Study Type: Observational
Study Design: Natural History
Expected Total Enrollment: 160
Study start: January 29, 1986; Study completion: December 14, 2000
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
Criteria
Location Information
Maryland
National Institute of Dental And Craniofacial Research (NIDCR), 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
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.
Record last reviewed: February 9, 2000
Last Updated: December 11, 2002
Record first received: November 3, 1999
ClinicalTrials.gov Identifier: NCT00001211
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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