Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients
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| First Received Date ICMJE | September 28, 2010 | ||||||||
| Last Updated Date | February 15, 2012 | ||||||||
| Start Date ICMJE | May 2010 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] To study the short term and long term osseous integration of implant supported restorations on immunocompromised (HIV positive) patients. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01211288 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients | ||||||||
| Official Title ICMJE | Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients | ||||||||
| Brief Summary | The purpose is to place implant in HIV positive and HIV negative patients, follow patients over 3 years period of time, to evaluate how well dental implants perform in HIV-positive patients versus HIV-negative patients. |
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| Detailed Description | The purpose is to place implant in HIV positive and HIV negative patients, follow patients over 3 years period of time, to evaluate how well dental implants perform in HIV-positive patients versus HIV-negative patients. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | In good general health with the following requirements: 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 (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 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 |
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| Condition ICMJE | HIV Positive Patient Receive Implant Supported Restoration | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | July 2015 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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:
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| Gender | Both | ||||||||
| Ages | 19 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01211288 | ||||||||
| Other Study ID Numbers ICMJE | F090730003 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Toni Neumeier, University of Alabama at Birmingham | ||||||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||||||
| Collaborators ICMJE | Dentsply Implants | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Alabama at Birmingham | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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