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Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects

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ClinicalTrials.gov Identifier: NCT00001211
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Description
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Brief 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


Condition or disease
Ectodermal Dysplasia Jaw, Edentulous

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

Study Design
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Study Type : Observational
Enrollment : 160 participants
Official Title: Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
Study Start Date : January 1986
Study Completion Date : December 2000

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Individuals with a need for replacement maxillary and mandibular complete dentures.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001211


Locations
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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
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Publications:

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ClinicalTrials.gov Identifier: NCT00001211    
Other Study ID Numbers: 860015
86-D-0015
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: February 2000
Keywords provided by National Institutes of Health Clinical Center (CC):
Ectodermal Dysplasia
Edentulous
Endosseous
Implants
 Mandibular Atrophy
Oral
Titanium
Additional relevant MeSH terms:
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Jaw, Edentulous
Mouth, Edentulous
Ectodermal Dysplasia
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
 Musculoskeletal Diseases
Abnormalities, Multiple
Congenital Abnormalities
Skin Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases