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| Name | Class |
|---|---|
| Osteogenics Biomedical | INDUSTRY |
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The purpose of this study is to clinically and radiographically assess whether the use of a ridge preservation technique significantly minimizes alveolar ridge resorption following tooth extraction.
Subjects requiring single-rooted tooth extractions and future tooth replacement therapy with implant-supported restorations will be recruited. Subjects will be randomly assigned to either a control (tooth extraction alone) or an experimental group (tooth extraction and ridge preservation using an allograft to fill the alveolar socket covered with a non-absorbable, dense polytetrafluoroethylene membrane [dPTFE]). Clinical linear measurements of the ridge (horizontal and vertical) will be obtained using a tooth-supported stent. Following extraction, primary closure of the socket will not be attempted. Subjects will be re-evaluated at 1 and 4 weeks. Implant placement surgery will be performed at 16 weeks. Clinical measurements will be repeated upon surgical re-entry. Cone beam computed tomographic (CBCT) scans will be obtained at baseline (after tooth extraction) and at 14 weeks (prior to implant placement) to assess alveolar ridge volumetric changes (primary outcome). Secondary outcome measures include changes in bucco-lingual and apico-coronal clinical measurements of the ridge and changes in modified wound healing index changes overtime. The influence of the thickness of the facial and lingual bone of the alveolar ridge and the width of the keratinized tissue on the remodeling of the ridge will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tooth extraction and grafting | Experimental | Tooth extraction and grafting with allograft |
|
| Tooth extraction | Sham Comparator | Tooth extraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tooth extraction and grafting with allograft | Procedure | Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane |
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar Ridge Volumetric Changes | 3D reconstructions using radiographic data obtained at baseline and at 14 weeks after the intervention was utilized to calculate the reduction of bone volume that took place during the healing period in both groups | Baseline to Week 14 after tooth extraction |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Bucco-lingual Ridge Dimension | Linear ridge width change at the bone crest | Baseline to Week 14 after tooth extraction |
| Changes in Apico-coronal Ridge Dimension | Linear ridge height change at the mid-facial aspect of the ridge |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Occasional, short-term use (7-14 days) of analgesics or common cold medications is permitted. Use of such medications will be reviewed and recorded by the investigator.
- Any other non-specified reason that from the point of views of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).
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| Name | Affiliation | Role |
|---|---|---|
| Gustavo Avila-Ortiz, DDS, MS, PhD | UI College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa College of Dentistry - Craniofacial Clinical Research Center | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32050833 | Derived | Avila-Ortiz G, Gubler M, Romero-Bustillos M, Nicholas CL, Zimmerman MB, Barwacz CA. Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial. J Dent Res. 2020 Apr;99(4):402-409. doi: 10.1177/0022034520905660. Epub 2020 Feb 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tooth Extraction and Grafting | Tooth extraction and grafting with allograft Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane |
| FG001 | Tooth Extraction | Tooth extraction Tooth extraction: Minimally traumatic single-rooted tooth extraction |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tooth Extraction and Grafting | Tooth extraction and grafting with allograft Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane |
| BG001 | Tooth Extraction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Alveolar Ridge Volumetric Changes | 3D reconstructions using radiographic data obtained at baseline and at 14 weeks after the intervention was utilized to calculate the reduction of bone volume that took place during the healing period in both groups | Posted | Mean | Standard Deviation | percentage of volume change | Baseline to Week 14 after tooth extraction |
|
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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 | Tooth Extraction and Grafting | Tooth extraction and grafting with allograft Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Alveolitis | Infections and infestations | Systematic Assessment | Dry Socket |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gustavo Avila-Ortiz | University of Iowa | 3193357241 | gustavo-avila@uiowa.edu |
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| ID | Term |
|---|---|
| D014081 | Tooth Extraction |
| D014180 | Transplantation |
| D014184 | Transplantation, Homologous |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
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|
| Tooth extraction | Procedure | Minimally traumatic single-rooted tooth extraction |
|
| Week 14 after tooth extraction |
Tooth extraction Tooth extraction: Minimally traumatic single-rooted tooth extraction |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Changes in Bucco-lingual Ridge Dimension | Linear ridge width change at the bone crest | Posted | Mean | 95% Confidence Interval | millimeters | Baseline to Week 14 after tooth extraction |
|
|
|
| Secondary | Changes in Apico-coronal Ridge Dimension | Linear ridge height change at the mid-facial aspect of the ridge | Posted | Median | Inter-Quartile Range | millimeters | Week 14 after tooth extraction |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Tooth Extraction | Tooth extraction Tooth extraction: Minimally traumatic single-rooted tooth extraction | 0 | 28 | 0 | 28 | 2 | 28 |
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