Completed

Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects

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What is being collected

Data Collection

Who is being recruted

Ectodermal Dysplasia

+ Jaw, Edentulous
How is the trial designed

Other

Observational
Study Start: January 1986

Summary

Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 1986Actual date on which the first participant was enrolled.

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 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

Official TitleClinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects 
Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
160 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Ectodermal Dysplasia
Jaw, Edentulous
Criteria

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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Institute of Dental And Craniofacial Research (NIDCR)Bethesda, United StatesSee the location

CompletedOne Study Center