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The purpose of this randomized controlled clinical trial was to evaluate two dimensionally and 3-dimensionally the effect of resorbable collagen-based bone filling material on periapical healing following endodontic microsurgery (EMS) on endodontic lesions presenting four-wall defect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Surgical sites (osteotomy) assigned to this group received endodontic microsurgery procedure+ Foundation (J. Morita USA). |
|
| Control | No Intervention | Surgical sites (osteotomy) assigned to this group receives endodontic microsurgery procedure only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foundation | Device | Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2D Radiographic Healing at 12 Months Follow up (Overall Cases) | Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing. | 12 months |
| 3D Radiographic Healing at 12 Months Follow up (Overall Cases) | Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing. | 12 months |
| 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing. | 12 months |
| 3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| C Score (Overall Cases) | Cortical plate healing using RAC/B index as evaluated on CBCT scans. Score 0: Cortical plate not re-established (Nonhealed). Score 1: Cortical plate is partially re-established (Partially healed). Score 2: Cortical plate is re-established (Completely healed). | 12 months |
| C Score (Asymptomatic Cases Only) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bekir Karabucak, DMD, MS | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPenn | Philadelphia | Pennsylvania | 19104 | United States |
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Start date of recruitment: 09/03/2019 End date of recruitment: 12/15/2020
Patients were consecutively enrolled until March 10th, 2020, after which all clinical and research activity was suspended due to the COVID-19 pandemic. The study was resumed in August 11th, 2020.
| ID | Title | Description |
|---|---|---|
| FG000 | Endodontic Microsurgery Only | Surgical sites assigned to this group receive Endodontic microsurgery procedure. |
| FG001 | Endodontic Microsurgery + Foundation | Surgical sites assigned to this group receive Endodontic microsurgery procedure+ Foundation (J. Morita USA). Foundation: Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
| ID | Title | Description |
|---|---|---|
| BG000 | Endodontic Microsurgery Only | Surgical sites assigned to this group received Endodontic microsurgery procedure. |
| BG001 | Foundation+ Endodontic Microsurgery | Surgical sites assigned to this group received Endodontic microsurgery procedure+ Foundation (J. Morita USA). Foundation: Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions. |
| 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 | 2D Radiographic Healing at 12 Months Follow up (Overall Cases) | Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing. | Analysis completed per osteotomy site. | Posted | Count of Units | osteotomy site | 12 months | osteotomy site | osteotomy site |
|
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All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
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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 | Endodontic Microsurgery | Surgical sites assigned to this group received endodontic microsurgery procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bekir Karabucak | University of Pennsylvania- Endodontic Department | 2158984927 | bekirk@upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2021 | Oct 26, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
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Cortical plate healing using RAC/B index as evaluated on CBCT scans. Score 0: Cortical plate not re-established (Nonhealed). Score 1: Cortical plate is partially re-established (Partially healed). Score 2: Cortical plate is re-established (Completely healed). |
| 12 months |
| BG002 | Total | Total of all reporting groups |
| Lesions |
|
| Count of Units |
| Lesions |
| Lesions |
|
|
| Sex: Female, Male | Count of Units | Lesions | Lesions |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
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| Arch | Count of Units | Lesions | Lesions |
|
|
| Tooth Type | Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions. | Count of Units | Lesions | Lesions |
|
|
|
|
| Primary | 3D Radiographic Healing at 12 Months Follow up (Overall Cases) | Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing. | Analysis completed per osteotomy site. | Posted | Count of Units | osteotomy sites | 12 months | osteotomy sites | osteotomy sites |
|
|
|
| Primary | 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing. | Analysis per osteotomy. Excluded participants presenting with symptoms. | Posted | Count of Units | osteotomy site | 12 months | osteotomy site | osteotomy site |
|
|
|
| Primary | 3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing | Analysis per osteotomy site. Excluded participants with symptoms. | Posted | Count of Units | osteotomy sites | 12 months | osteotomy sites | osteotomy sites |
|
|
|
| Secondary | C Score (Overall Cases) | Cortical plate healing using RAC/B index as evaluated on CBCT scans. Score 0: Cortical plate not re-established (Nonhealed). Score 1: Cortical plate is partially re-established (Partially healed). Score 2: Cortical plate is re-established (Completely healed). | Analysis per osteotomy site. | Posted | Count of Units | osteotomy sites | 12 months | osteotomy sites | osteotomy sites |
|
|
|
| Secondary | C Score (Asymptomatic Cases Only) | Cortical plate healing using RAC/B index as evaluated on CBCT scans. Score 0: Cortical plate not re-established (Nonhealed). Score 1: Cortical plate is partially re-established (Partially healed). Score 2: Cortical plate is re-established (Completely healed). | Analysis per osteotomy site. Excluded participants with symptoms. | Posted | Count of Units | osteotomy sites | 12 months | osteotomy sites | osteotomy sites |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Endodontic Microsurgery + Foundation | Surgical sites assigned to this group received endodontic microsurgery procedure+ Foundation (J. Morita USA). Foundation: Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |
| Unsatisfactory |
|
| Uncertain |
|
| Unsatisfactory |
|
| Unsatisfactory |
|
| C-score 0 |
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| C-score 0 |
|