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CompletedNCT00001211Updated Mar 4, 2008

Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects

An observational study in Ectodermal Dysplasia and Jaw, Edentulous, sponsored by National Institute of Dental and Craniofacial Research (NIDCR). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.

Sponsored by National Institute of Dental and Craniofacial Research (NIDCR) · Observational

Study type
Observational
Enrollment
160
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Ectodermal Dysplasia
  • Jaw, Edentulous

Keywords

  • Ectodermal Dysplasia
  • Edentulous
  • Endosseous
  • Implants
  • Mandibular Atrophy
  • Oral
  • Titanium
03

In context

Ectodermal Dysplasia

10 studies on the registry are indexed under Ectodermal Dysplasia; 6 are open to participants now.

Browse Ectodermal Dysplasia studies →

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR) is the lead sponsor of 94 studies on the registry; 9 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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

05

Study design

Enrollment
160 participants
06

Study locations

1 site
  • National Institute of Dental And Craniofacial Research (NIDCR)
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • 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. PubMed 273089 ↗
  • 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. PubMed 5254404 ↗
  • 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. PubMed 4569753 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00001211
First posted
Dec 10, 2002
Start date
Jan 1986
Completion
Dec 2000
Last update
Mar 4, 2008
View the source record on ClinicalTrials.gov ↗

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