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

Not Applicable

• Conditions: Jaw, Edentulous, Partially
• Interventions: Device: Surgical Template

• Registration Number: NCT02772172
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-13
• Study Start: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-17
• Primary Completion: 2017-11
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GuideMia surgical template	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.
Control surgical template	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Implant and prosthesis survival	Up to 18 months after baseline	Implant and prosthesis survival will be determined at 6 months，12months and 18 months
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
Modified plaque index	Up to 18 months after baseline	Modified plaque index will be recorded 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

Trial Locations

Locations (1)

Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China