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| Name | Class |
|---|---|
| Geistlich Pharma AG | INDUSTRY |
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The goal of this clinical trial is to histologically, clinically, and radiographically evaluate the healing sequelae of periodontally compromised extraction sockets grafted with Bio-Oss Collagen® at 3 and 6 months following tooth extraction in molar sites. The main question it aims to answer is:
Does healing time influence the histologic, clinical, and radiographic outcomes following socket grafting (alveolar ridge preservation) in periodontally compromised extraction sockets.
Researchers will compare a healing time of 3 months to a healing time of 6 months (conventional healing duration) to see if a shorter duration is viable for implant placement.
Participants will:
Take a cone-beam computed tomography (CBCT) scan to prepare for the surgical procedure.
Undergo tooth extraction and the extraction socket will be grafted with Bio-Oss Collagen® and a collagen membrane Bio-Gide® will be placed to stabilize the graft material.
Return at 2 weeks for suture removal and either 3- or 6-months post-extraction for implant placement.
Return at 2 weeks post-implant placement for suture removal, 3 months for prosthesis fabrication, 4 months for final prosthesis loading, and 1 year post-loading.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant placement 3 months after tooth extraction | Experimental | Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement 3 months after tooth extraction |
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| Implant placement 6 months after tooth extraction | Active Comparator | Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement 6 months after tooth extraction |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alveolar ridge preservation | Procedure | Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement at 2 different time intervals (3 and 6 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months | Percentage of vital bone | 3 months |
| Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 6 months | Percentage of vital bone | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (3 months) | Clinical and radiographic (via CBCT) assessment. The buccal-lingual ridge width at the time of the extraction will be measured clinically using a periodontal probe (UNC-15) and prior to implant placement (3-months). The same measurements will be performed radiographically through the CBCTs taken prior to tooth extraction and prior to implant placement, utilizing a CBCT viewer software. The linear vertical alterations will be used utilizing the same methods, using fiduciary anatomical landmarks. Superimposition of the digital files obtained from the intra-oral scanner will be utilized to verify these changes clinically. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinbo Yu, BDS | Contact | 86+23271699 | 6057 | xinboyu@proton.me |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital | Recruiting | Shanghai | 201999 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24966231 | Background | Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25. | |
| 38884702 | Background | Dai A, Li HY, Kang S, Lin R, Huang JP, Mao F, Ding PH. Effect of alveolar ridge preservation at periodontally compromised molar extraction sockets: A retrospective cohort study. J Periodontol. 2025 Jan;96(1):9-20. doi: 10.1002/JPER.24-0064. Epub 2024 Jun 17. |
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| 3 months |
| Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (6 months) | Clinical and radiographic (via CBCT) assessment. The buccal-lingual ridge width at the time of the extraction will be measured clinically using a periodontal probe (UNC-15) and prior to implant placement (6-months). The same measurements will be performed radiographically through the CBCTs taken prior to tooth extraction and prior to implant placement, utilizing a CBCT viewer software. The linear vertical alterations will be used utilizing the same methods, using fiduciary anatomical landmarks. Superimposition of the digital files obtained from the intra-oral scanner will be utilized to verify these changes clinically. | 6 months |
| Assessment of the mucosal healing of the extraction sites at 2 weeks using a wound healing index (1-3 scale rating) | Wound Healing Index.1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration | 2 weeks following tooth extraction and alveolar ridge preservation |
| Assessment of the mucosal healing after implant placement at 2 weeks using a wound healing index (1-3 scale rating) | Wound Healing Index.1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration | 2 weeks after dental implant placement |
| Patient reported outcomes (number of days of total or partially impaired activity) following tooth extraction | Number of days of total or partially impaired activity | At the time of implant placement (3 or 6 months) |
| Patient reported outcomes (number of days of total or partially impaired activity) following implant placement | Number of days of total or partially impaired activity | 4 months post implant placement |
| Patient reported outcomes (pain) 2 weeks following tooth extraction, using a Visual Analog Score for pain (0-100) | Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable"). | 2 weeks following tooth extraction and alveolar ridge preservation |
| Patient reported outcomes (pain) 3 months following tooth extraction, using a Visual Analog Score for pain (0-100) | Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable"). | 3 months following tooth extraction and alveolar ridge preservation |
| Patient reported outcomes (pain) 6 months following tooth extraction, using a Visual Analog Score for pain (0-100) | Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable"). | 6 months following tooth extraction and alveolar ridge preservation |
| Patient reported outcomes (patient satisfaction), using a Visual Analog Scale (0-100) | Patients will be asked to rate their satisfaction in terms of function, comfort and esthetics, using a Visual Analog Scale (0-100, with 0 meaning "not at satisfied at all" and 100 corresponding to "perfectly satisfied"). | Up to 30 days post implant crown delivery |
| Implant survival rate | Percentage of implants still in the mouth | 1 year post implant loading |
| Marginal bone level changes | Measured in millimeters using standardized parallel technique intraoral radiographs | 1 year post implant loading |
| 33316099 | Background | Ben Amara H, Kim JJ, Kim HY, Lee J, Song HY, Koo KT. Is ridge preservation effective in the extraction sockets of periodontally compromised teeth? A randomized controlled trial. J Clin Periodontol. 2021 Mar;48(3):464-477. doi: 10.1111/jcpe.13412. Epub 2021 Jan 19. |
| 36527199 | Background | Zellner JW, Allen HT, Kotsakis GA, Mealey BL. Wound healing after ridge preservation: A randomized controlled trial on short-term (4 months) versus long-term (12 months) histologic outcomes. J Periodontol. 2023 May;94(5):622-629. doi: 10.1002/JPER.22-0187. Epub 2023 Jan 10. |
| 36345818 | Background | Couso-Queiruga E, Weber HA, Garaicoa-Pazmino C, Barwacz C, Kalleme M, Galindo-Moreno P, Avila-Ortiz G. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: A randomized clinical trial. J Clin Periodontol. 2023 Feb;50(2):132-146. doi: 10.1111/jcpe.13744. Epub 2022 Nov 18. |
| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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