Ectodermal DysplasiaNCT00001211
Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
An observational study of Ectodermal Dysplasia and Jaw, Edentulous, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ectodermal Dysplasia, Jaw, Edentulous
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1986to Dec 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Individuals with a need for replacement maxillary and mandibular complete dentures.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
About this 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.
Read more
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
- Conditions
- Ectodermal Dysplasia, Jaw, Edentulous
- Keywords
- Ectodermal Dysplasia, Edentulous, Endosseous, Implants, Mandibular Atrophy, Oral, Titanium
- Medical subject headings
- Ectodermal Dysplasia, Jaw, Edentulous, Mouth, Edentulous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJan 1986
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ectodermal DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001211
- Sponsor's protocol ID
- 860015
- Other IDs
- 86-D-0015
- Status last verified
- Feb 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
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 273089Bolender 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 5254404Bergman 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects
- ClinicalTrials.gov ID
- NCT00001211
- Acronym / sponsor ID
- 860015
- Conditions
- Ectodermal Dysplasia, Jaw, Edentulous
- Keywords
- Ectodermal Dysplasia, Edentulous, Endosseous, Implants, Mandibular Atrophy, Oral, Titanium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Jan 1986
- Study completion
- Dec 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 273089Guckes 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.
- Background: PubMed 5254404Bolender 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.
- Background: PubMed 4569753Bergman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ectodermal Dysplasia and Jaw, Edentulous, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001211, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.