Site Preservation After Tooth Extraction

Study Overview
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Brief Summary
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This study is mainly targeted affected teeth which could not be retained, and patients are willing to undergo implant repair at the later stage. After teeth extraction, Geistlich Bio-Oss ® Particles or Bio-Oss ® Collagen are immediately implanted in the teeth extraction socket and covered with Bio-Gide ® collagen membrane for site preservation.Through postoperative follow-up, postoperative clinical and imaging objective indicators, combined with the subjective evaluation of surgeons and patients, and compared with conventional extraction treatment method, the study is aimed to evaluate the effectiveness of different site preservation of alveolar crest preservation, in order to reduce the alveolar bone width and height loss, effectively reduce alveolar bone absorption, or even achieve bone incrementation, thus to get the ideal site preservation effect, to improve the oral implant success rate, improve implant aesthetic score and patient satisfaction, provide more clinical standard reference of the clinical application of site preservation.

Official Title
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Prospective Clinical Study on Site Preservation of Alveolar Ridge After Tooth Extraction Before Dental Implantation

Conditions
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Osteogenesis Imperfecta, Total Absence of Permanent Teeth, Tooth Socket

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients willing to performed site preservation with Geistlich Bio-Oss ® Particles + Bio-Gide ® collagen membrane after tooth extraction; patients willing to performed site preservation with Geistlich Bio-Oss ® Collagen + Bio-Gide ® collagen membrane after tooth extraction; patients willing to performed no site preservation after tooth extraction and only conventional healing. Exclusion Criteria: patients unwilling to sign the informed consent form and the letter of authorization; patients has a potential systematic diseases; patients had previously been treated with radiation therapy; patients can not re-visit on time.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Geistlich Bio-Oss ® Particles + Bio-Gide ® collagen membrane<br>The first group of patients selected for site preservation will be performed with Bio-Oss ® Particles + Bio-Gide ® collagen membrane after tooth extraction | |
| Geistlich Bio-Oss ® Collagen + Bio-Gide ® collagen membrane<br>The second group of patients selected for site preservation will be performed with Bio-Oss ® Collagen + Bio-Gide ® collagen membrane after tooth extraction | |
| Conventional healing after tooth extraction, without site preservation<br>The third group of patients selected will be performed without site preservation after tooth extraction, and only conventional healing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the alveolar crest height - central | The central alveolar bone height of the ideal implant site will be measured with CBCT at 3 months after tooth extraction or plus site preservation | up to 12 weeks after Dental extraction or site preservation surgery | 
| Changes in the alveolar crest width - central | The central alveolar bone width of the ideal implant site will be measured with CBCT at 3 months after tooth extraction alone or plus site preservation | up to 12 weeks after Dental extraction or site preservation surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the alveolar bone width - different depths | The width of the alveolar bone at 1,3,5, and 7mm below the alveolar crest will be measured with CBCT at 3 months after tooth extraction or plus site preservation | up to 12 weeks after Dental extraction or site preservation surgery | 
| Changes in the alveolar bone height - different horizontal sites | The height of the alveolar bone will be measured at the mesial, central and distal of buccal and lingual of alveolar crest,and the midpoint of the mesial and distal of interproximal sites with CBCT at 3 months after tooth extraction alone or plus site preservation | up to 12 weeks after Dental extraction or site preservation surgery | 
| Soft tissue thickness | The thickness of soft tissue will be measured at middle, central, and distal sites of both buccal-lingual sides,3mm from free gingival margin | up to 12 weeks after Dental extraction or site preservation surgery | 
| Plaque index (PLI) | Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides | up to 12 weeks after Dental extraction or site preservation surgery | 
| Bleeding index (BI) | Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides | up to 12 weeks after Dental extraction or site preservation surgery | 
| Probing depth (PD) | Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides | up to 12 weeks after Dental extraction or site preservation surgery | 
| Phenotype assessment | Whether thick or thin gingival biotype will be detected by the transparency of the soft tissue while periodontal probing diagnosis | up to 12 weeks after Dental extraction or site preservation surgery | 
| Pain degree | The Visual Analogue Scale (VAS) pain score was evaluated: 0-10 (0: no pain; 1-3: slightly painful, acceptable; 4-6: painful, disrupt sleep, tolerable; 7-10: very painful, untolerable, affect sleep and diet) | up to 12 weeks after Dental extraction or site preservation surgery. |