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

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ClinicalTrials.gov Identifier: NCT02772172
Recruitment Status : Unknown
Verified May 2016 by Zhuofan Chen, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : May 13, 2016
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
Zhuofan Chen, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Device: Surgical Template Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates: a Randomized Controlled Clinical Trial
Study Start Date : August 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : February 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Device: Surgical Template
Other Names:
  • GuideMia
  • control
Active Comparator: 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.
 Device: Surgical Template
Other Names:
  • GuideMia
  • control


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Implant and prosthesis survival [ Time Frame: Up to 18 months after baseline ]
    Implant and prosthesis survival will be determined at 6 months，12months and 18 months

  2. Radiographic bone level [ Time Frame: Up to 18 months after baseline ]
    Radiographic bone level will be recorded at 6 months，12months and 18 months

  3. The incidence of biological and mechanical complications [ Time Frame: Up to 18 months after baseline ]
    The incidence of biological and mechanical complications will be recorded at baseline, 6 months，12months and 18 months

  4. Probing depth [ Time Frame: Up to 18 months after baseline ]
    Probing depth will be recorded at 6 months，12months and 18 months

  5. Modified plaque index [ Time Frame: Up to 18 months after baseline ]
    Modified plaque index will be recorded at 6 months，12months and 18 months

  6. Modified bleeding index [ Time Frame: Up to 18 months after baseline ]
    Modified bleeding index will be recorded at 6 months，12months and 18 months

  7. Gingival index [ Time Frame: Up to 18 months after baseline ]
    Gingival index will be recorded at 6 months，12months and 18 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772172


Contacts
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Contact: Zhuofan Chen, Professor +86-20-83862537 1330177020@qq.com
Contact: Xin Liu +8615902064014 838667172@163.com

Locations
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China, Guangdong
Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Zhuofan Chen, professor    ＋8613902241868    dentistczf@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Zhuofan Chen, professor School of Stomatology, Hospital of Stomatology, Sun Yat-Sen University
More Information
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Publications of Results:

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Responsible Party: Zhuofan Chen, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02772172    
Other Study ID Numbers: ZhuofanChen
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Mouth Diseases
 Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases