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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-02-28

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.

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Detailed Description

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Conditions

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Jaw, Edentulous, Partially

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Surgical Template

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Surgical Template

Intervention Type DEVICE

Interventions

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Surgical Template

Intervention Type DEVICE

Other Intervention Names

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GuideMia control

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No