Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects

NCT00001211 | Completed

• 2 other identifiers: 86001586-D-0015
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Ectodermal Dysplasia; Jaw, Edentulous

Keywords

Ectodermal Dysplasia; Edentulous; Endosseous; Implants; Mandibular Atrophy; Oral; Titanium

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 273089 BACKGROUND

• 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.

  PMID: 5254404 BACKGROUND

• 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.

  PMID: 4569753 BACKGROUND

MeSH Terms

Conditions

Ectodermal Dysplasia; Jaw, Edentulous; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: January 1, 1986
• Study Completion: December 1, 2000
• Last Updated: March 4, 2008

Record last verified: 2000-02

Locations

US (1)