Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates: a Randomized Controlled Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Jaw, Edentulous, Partially
- Sponsor
- Sun Yat-sen University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Position changes between the planned and achieved implant position
- Last Updated
- 9 years ago
Overview
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.
Investigators
Zhuofan Chen
professor
Sun Yat-sen University
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Implant and prosthesis survival(Up to 18 months after baseline)
- Radiographic bone level(Up to 18 months after baseline)
- The incidence of biological and mechanical complications(Up to 18 months after baseline)
- Probing depth(Up to 18 months after baseline)
- Modified plaque index(Up to 18 months after baseline)
- Modified bleeding index(Up to 18 months after baseline)
- Gingival index(Up to 18 months after baseline)