Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates
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ClinicalTrials.gov Identifier: NCT02772172 |
Recruitment Status : Unknown
Verified May 2016 by Zhuofan Chen, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : May 13, 2016
Last Update Posted : August 17, 2016
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Condition or disease | Intervention/treatment | Phase |
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Jaw, Edentulous, Partially | Device: Surgical Template | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates: a Randomized Controlled Clinical Trial |
Study Start Date : | August 2016 |
Estimated Primary Completion Date : | November 2017 |
Estimated Study Completion Date : | February 2018 |
Arm | Intervention/treatment |
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Active Comparator: GuideMia surgical template
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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Device: Surgical Template
Other Names:
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Active Comparator: Control surgical template
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.
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Device: Surgical Template
Other Names:
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- Position changes between the planned and achieved implant position [ Time Frame: Change from preoperative to postoperative within 1 week ]Accuracy analysis. The linear and angular deviations between the planned and achieved implant position are analyzed.
- Implant and prosthesis survival [ Time Frame: Up to 18 months after baseline ]Implant and prosthesis survival will be determined at 6 months,12months and 18 months
- Radiographic bone level [ Time Frame: Up to 18 months after baseline ]Radiographic bone level will be recorded at 6 months,12months and 18 months
- The incidence of biological and mechanical complications [ Time Frame: Up to 18 months after baseline ]The incidence of biological and mechanical complications will be recorded at baseline, 6 months,12months and 18 months
- Probing depth [ Time Frame: Up to 18 months after baseline ]Probing depth will be recorded at 6 months,12months and 18 months
- Modified plaque index [ Time Frame: Up to 18 months after baseline ]Modified plaque index will be recorded at 6 months,12months and 18 months
- Modified bleeding index [ Time Frame: Up to 18 months after baseline ]Modified bleeding index will be recorded at 6 months,12months and 18 months
- Gingival index [ Time Frame: Up to 18 months after baseline ]Gingival index will be recorded at 6 months,12months and 18 months

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Partial edentulism
- Missing more than three teeth in succession
- Presence of adjacent teeth
- Systemically healthy
- Good maxillomandibular relation
- Maximal mouth opening>5 mm
Exclusion Criteria:
- Poor oral hygiene
- Severe parafunctional habits, for example, bruxing and clenching
- Presence of clinically active periodontal disease as expressed by probing pocket depths≥4 mm in combination with bleeding on probing
- Maxillary sinus involvement
- Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease
- Pregnant or expecting to be pregnant
- History of drug and alcohol abuse
- History of systemic diseases that would contraindicate oral surgical treatment, for example, uncontrolled diabetes (defined as HBA1c level >7%)
- Radiotherapy in the head and neck area
- On certain medications like bisphosphonates or steroids currently or within the past three months
- Unwillingness to return for the follow-up examination
- Smokers (more than20 cigarettes per day). Subjects smoking <20 cigarettes per day were requested to stop smoking before and after surgery

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772172
Contact: Zhuofan Chen, Professor | +86-20-83862537 | 1330177020@qq.com | |
Contact: Xin Liu | +8615902064014 | 838667172@163.com |
China, Guangdong | |
Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University | Recruiting |
Guangzhou, Guangdong, China, 510000 | |
Contact: Zhuofan Chen, professor +8613902241868 dentistczf@163.com |
Principal Investigator: | Zhuofan Chen, professor | School of Stomatology, Hospital of Stomatology, Sun Yat-Sen University |
Responsible Party: | Zhuofan Chen, professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT02772172 |
Other Study ID Numbers: |
ZhuofanChen |
First Posted: | May 13, 2016 Key Record Dates |
Last Update Posted: | August 17, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Jaw, Edentulous Jaw, Edentulous, Partially Mouth, Edentulous Mouth Diseases |
Stomatognathic Diseases Tooth Diseases Jaw Diseases Musculoskeletal Diseases |