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Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects - Article


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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.

Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: Warren G Magnuson Clinical Center (CC)

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

Further Study Details: 

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

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

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.

Study ID Numbers:  860015; 86-D-0015
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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August 21, 2008



Page Updated: September 6, 2005
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