Jaw, Edentulous, Partially
Conditions
Brief summary
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.
Interventions
DEVICESurgical Template
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Position changes between the planned and achieved implant position | Change from preoperative to postoperative within 1 week | Accuracy analysis. The linear and angular deviations between the planned and achieved implant position are analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic bone level | 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 | 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 | Up to 18 months after baseline | Probing depth will be recorded at 6 months，12months and 18 months |
| Implant and prosthesis survival | Up to 18 months after baseline | Implant and prosthesis survival will be determined at 6 months，12months and 18 months |
| Modified bleeding index | Up to 18 months after baseline | Modified bleeding index will be recorded at 6 months，12months and 18 months |
| Gingival index | Up to 18 months after baseline | Gingival index will be recorded at 6 months，12months and 18 months |
| Modified plaque index | Up to 18 months after baseline | Modified plaque index will be recorded at 6 months，12months and 18 months |
Countries
China
Contacts
Primary ContactZhuofan Chen, Professor
Backup ContactXin Liu
Outcome results
None listed