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The main purpose of the present study is to evaluate the dental implant placement using two different CBCT-derived templates and to study the related factors that affect accuracy so as to support the further clinical application of the technique. Thirty patients with partial edentulous denture are recruited. They are randomized to two groups. A radiographic guide is prepared before CT/CBCT scan. The CT/CBCT scan DICOM files are loaded in a planning program and converted into 3D computer images. A surgical template is fabricated through this virtual planning. After 6 weeks, if the implants are judged stable, the patient has the option of replacing the fixed prosthesis. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GuideMia surgical template | Active Comparator | A radiographic guide is prepared before CT/CBCT scan. The CT/CBCT scan DICOM files are loaded in GuideMia program and converted into 3D computer images. A surgical template is fabricated through this virtual planning. |
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| Control surgical template | Active Comparator | A radiographic guide is prepared before CT/CBCT scan. The CT/CBCT scan DICOM files are loaded in control program and converted into 3D computer images. A surgical template is fabricated through this virtual planning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Template | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Position changes between the planned and achieved implant position | Accuracy analysis. The linear and angular deviations between the planned and achieved implant position are analyzed. | Change from preoperative to postoperative within 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Implant and prosthesis survival | Implant and prosthesis survival will be determined at 6 months,12months and 18 months | Up to 18 months after baseline |
| Radiographic bone level | Radiographic bone level will be recorded at 6 months,12months and 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhuofan Chen, Professor | Contact | +86-20-83862537 | 1330177020@qq.com | |
| Xin Liu | Contact | +8615902064014 | 838667172@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhuofan Chen, professor | School of Stomatology, Hospital of Stomatology, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25195544 | Result | Lopes A, Malo P, de Araujo Nobre M, Sanchez-Fernandez E. The NobelGuide(R) All-on-4(R) Treatment Concept for Rehabilitation of Edentulous Jaws: A Prospective Report on Medium- and Long-Term Outcomes. Clin Implant Dent Relat Res. 2015 Oct;17 Suppl 2:e406-16. doi: 10.1111/cid.12260. Epub 2014 Sep 5. | |
| 24341829 | Result |
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| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
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| Up to 18 months after baseline |
| The incidence of biological and mechanical complications | The incidence of biological and mechanical complications will be recorded at baseline, 6 months,12months and 18 months | Up to 18 months after baseline |
| Probing depth | Probing depth will be recorded at 6 months,12months and 18 months | Up to 18 months after baseline |
| Modified plaque index | Modified plaque index will be recorded at 6 months,12months and 18 months | Up to 18 months after baseline |
| Modified bleeding index | Modified bleeding index will be recorded at 6 months,12months and 18 months | Up to 18 months after baseline |
| Gingival index | Gingival index will be recorded at 6 months,12months and 18 months | Up to 18 months after baseline |
| Sun Y, Luebbers HT, Agbaje JO, Schepers S, Politis C, Van Slycke S, Vrielinck L. Accuracy of Dental Implant Placement Using CBCT-Derived Mucosa-Supported Stereolithographic Template. Clin Implant Dent Relat Res. 2015 Oct;17(5):862-70. doi: 10.1111/cid.12189. Epub 2013 Dec 16. |
| 23789721 | Result | Polizzi G, Cantoni T. Five-year follow-up of immediate fixed restorations of maxillary implants inserted in both fresh extraction and healed sites using the NobelGuide system. Clin Implant Dent Relat Res. 2015 Apr;17(2):221-33. doi: 10.1111/cid.12102. Epub 2013 Jun 23. |
| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |