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Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients
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Purpose
| Condition |
|---|
| Peri-Implantitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Control Time Perspective: Prospective |
| Official Title: | Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients |
- To study the short term and long term osseous integration of implant supported restorations on immunocompromised (HIV positive) patients. [ Time Frame: Every 6 months after implant restoration complete ]To study the short term and long term osseous integration of implant supported restorations on immunocompromised (HIV positive) patients.
- Radiographic examination of implant osseous integration using Cone Beam CT and traditional vertical bitewing radiographs. [ Time Frame: one year after implant restoration ]Radiographic examination of implant osseous integration using Cone Beam CT and traditional vertical bitewing radiographs.
- Histologic examination of bone biopsies from each implant surgical site, at the time of initial placement, and from failing implant sites, including histologic examination of the implant-bone interface. [ Time Frame: at the initial implant placement surgical site ]Histologic examination of bone biopsies from each implant surgical site, at the time of initial placement, and from failing implant sites, including histologic examination of the implant-bone interface.
| Estimated Enrollment: | 40 |
| Actual Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | June 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
control group
Age 19 and older, Non- smoker (quite smoking at least 6 months) Controlled Type II diabetes Controlled hypertension Non bisphosphate user Non- bruxer
|
|
HIV positive
HIV (+) patients with the following requirements: Age 19 and older, Hemoglobin >8g/dl , Absolute neutrophil count >750/mm3, Platelet count>75,000cells/mm3, AST< 5 times the upper limit of normal (ULN), Bilirubin< 2.5 times ULN, Alkaline phosphate < 5 times ULN, Creatinine< 2.5 mg/ml Non- smoker (quite smoking at least 6 months) Controlled Type II diabetes Controlled hypertension Non bisphosphate user Non- bruxer |
Detailed Description:
Eligibility| Ages Eligible for Study: | 19 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
In good general health with the following requirements:
Absolute neutrophil count >750/mm3 Platelet count>75,000cells/mm3 AST< 5 times the upper limit of normal (ULN) Non- smoker (quit smoking at least 6 months) Controlled - If type II diabetes Controlled - if hypertension Non bisphosphate user Non- bruxer Misch Available Bone classification divisions A, B, C Misch Bone Density classification D1, D2, D3 Minimal available bone width 5mm Minimal available bone height 10mm Extraction site has to be healed up for minimum 6 months before implant placement
Implant supported restorations are limited to the following edentulous areas:
Mandibular arches, excluding 3rd molar areas Maxillary anterior and premolar areas
Inclusion Criteria:
- The existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction
- Healthy enough to undergo the proposed therapy without compromise to existing health status
- At least 19 years old
- Able to read and understand written English without the aid of ad hoc interpretation
- Able to cognitively understand the proposed study and therapy and possible prognoses
- Able to consent for their own inclusion in the study.
Hemoglobin >8g/dl Absolute neutrophil count >750/mm3 Platelet count>75,000cells/mm3 AST< 5 times the upper limit of normal (ULN) Bilirubin< 2.5 times ULN Alkaline phosphate < 5 times ULN Creatinine< 2.5 mg/ml Non- smoker (quite smoking at least 6 months) Controlled Type II diabetes Controlled hypertension Non bisphosphate user Non- bruxer Misch Available Bone classification divisions A, B, C Misch Bone Density classification D1, D2, D3 Minimal available bone width 5mm Minimal available bone height 10mm Minimum bone graft with freeze dried demineralised bone upon implant placement Extraction site has to be healed up for minimum 6 months before implant placement
Implant supported restorations are limited to the following edentulous areas:
Mandibular arches, excluding 3rd molar areas Maxillary anterior and premolar areas
Exclusion Criteria:
- Women who are pregnant or lactating at the time of enrollment
- Previous malignant neoplasm
- A known hypersensitivity to Titanium metal
- Any medication/condition that in the opinion of the clinical investigators may adversely affect bone healing
- Any indication of an inability to autonomous decisions
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01211288
| United States, Alabama | |
| UAB Dental School | |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: | Toni T Neumeier, DMD | UAB Dental School |
More Information
| Responsible Party: | Toni Neumeier, Associate professor, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01211288 History of Changes |
| Other Study ID Numbers: |
F090730003 |
| Study First Received: | September 28, 2010 |
| Last Updated: | July 19, 2017 |
Keywords provided by Toni Neumeier, University of Alabama at Birmingham:
|
HIV Implant Crown |
Additional relevant MeSH terms:
|
Peri-Implantitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on September 21, 2017