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| Name | Class |
|---|---|
| Osteogenics Biomedical | INDUSTRY |
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Following tooth extraction ridge preservation procedure have been suggested to limit bone resorptive dimensional changes to facilitate prospective implant placement. While this is particularly true for anterior teeth, no evidence is available to establish clinical guidelines in posterior sites, i.e. following molar extraction.
This research project will answer the following question:
What are the dimensional changes of the hard and soft tissues encountered following molar extractions with and without ridge preservation?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ridge preservation | Other | The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not "dissolve" by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called "Ridge preservation" |
|
| No ridge preservation | Other | The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. "Spontaneous Healing" (No ridge preservation is performed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ridge preservation | Procedure | Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Bone Changes | The width and the height of the alveolar ridge will be measured (in mm) on the initial (i.e. following tooth extraction) Cone Beam CT and on the CBCT taken prior to implant placement (i.e. 3 months after tooth extraction) | 3 months after tooth extraction |
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Inclusion Criteria:
Patients will be included in this study if they qualify the following inclusion criteria:
Exclusion Criteria:
Obvious exclusions are patients who do not meet all the inclusion criteria or who will not cooperate with the follow-up schedule.
Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
Pregnant women or women intending to become pregnant during the study period. As standard practice prior to dental surgery, females of child-bearing age are asked verbally if there is any possibility that they are pregnant. If not, we proceed with surgery and no pregnancy test is done. If the woman states that there is a possibility that she is pregnant, we do a urine pregnancy test to rule pregnancy in or out. So use of the urine pregnancy test is only done if she says she may be pregnant. [If needed: An over-the-counter urine pregnancy test will be provided to female subjects in the graduate periodontics clinic of UTHSCSA. Patients will be allowed access to a private restroom and the results of the tests will be read by one of the named investigators. Only those with a negative pre-operative pregnancy test will be eligible for the study.] Female patients who have undergone a hysterectomy, tubal ligation or menopause will be excluded from pregnancy testing.
Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
Clinical and/or radiographic determinations which will preclude inclusion in this study are:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27788625 | Derived | Walker CJ, Prihoda TJ, Mealey BL, Lasho DJ, Noujeim M, Huynh-Ba G. Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):241-249. doi: 10.1902/jop.2016.160445. Epub 2016 Oct 27. |
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Location: Graduate Periodontics clinic at the University of Texas Health Science Center at San Antonio (UTHSCSA), San Antonio, Texas Date: January 2014 to May 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | Ridge Preservation | The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not "dissolve" by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called "Ridge preservation" Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site. |
| FG001 | No Ridge Preservation | The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. "Spontaneous Healing" (No ridge preservation is performed) Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ridge Preservation | The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not "dissolve" by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called "Ridge preservation" Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radiographic Bone Changes | The width and the height of the alveolar ridge will be measured (in mm) on the initial (i.e. following tooth extraction) Cone Beam CT and on the CBCT taken prior to implant placement (i.e. 3 months after tooth extraction) | Posted | Mean | Standard Error | millimeter | 3 months after tooth extraction |
|
Data were collected until study completion that is when the patient received their dental implant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ridge Preservation | The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not "dissolve" by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called "Ridge preservation" Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guy Huynh-Ba | UTHSCSA Periodontics | 2105673569 | huynhba@uthscsa.edu |
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| BG001 | No Ridge Preservation | The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. "Spontaneous Healing" (No ridge preservation is performed) Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | No Ridge Preservation | The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. "Spontaneous Healing" (No ridge preservation is performed) Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site. |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | No Ridge Preservation | The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. "Spontaneous Healing" (No ridge preservation is performed) Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site. | 0 | 20 | 0 | 20 | 0 | 20 |
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