Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates

Study Overview
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Brief Summary
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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.

Official Title
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Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates: a Randomized Controlled Clinical Trial

Conditions
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Jaw, Edentulous, Partially

Intervention / Treatment
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* Device: Surgical Template


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GuideMia surgical template<br>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. | Device: Surgical Template<br> <br> * Other names: control;|
| Active Comparator: Control surgical template<br>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. | Device: Surgical Template<br> <br> * Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |