Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
Primary Purpose
Ectodermal Dysplasia, Jaw, Edentulous
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Ectodermal Dysplasia focused on measuring Ectodermal Dysplasia, Edentulous, Endosseous, Implants, Mandibular Atrophy, Oral, Titanium
Eligibility Criteria
Individuals with a need for replacement maxillary and mandibular complete dentures.
Sites / Locations
- National Institute of Dental And Craniofacial Research (NIDCR)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001211
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
1. Study Identification
Unique Protocol Identification Number
NCT00001211
Brief Title
Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
Official Title
Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
Study Type
Observational
2. Study Status
Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
January 1986 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
4. Oversight
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectodermal Dysplasia, Jaw, Edentulous
Keywords
Ectodermal Dysplasia, Edentulous, Endosseous, Implants, Mandibular Atrophy, Oral, Titanium
7. Study Design
Enrollment
160 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Individuals with a need for replacement maxillary and mandibular complete dentures.
Facility Information:
Facility Name
National Institute of Dental And Craniofacial Research (NIDCR)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
273089
Citation
Guckes AD, Smith DE, Swoope CC. Counseling and related factors influencing satisfaction with dentures. J Prosthet Dent. 1978 Mar;39(3):259-67. doi: 10.1016/s0022-3913(78)80092-4. No abstract available.
Results Reference
background
PubMed Identifier
5254404
Citation
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. doi: 10.1016/0022-3913(69)90268-6. No abstract available.
Results Reference
background
PubMed Identifier
4569753
Citation
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. doi: 10.3109/00016357209002493. No abstract available.
Results Reference
background
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Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
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