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

Primary Purpose

Jaw, Edentulous, Partially

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Surgical Template
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

GuideMia surgical template

Control surgical template

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Position changes between the planned and achieved implant position
Accuracy analysis. The linear and angular deviations between the planned and achieved implant position are analyzed.

Secondary Outcome Measures

Implant and prosthesis survival
Implant and prosthesis survival will be determined at 6 months，12months and 18 months
Radiographic bone level
Radiographic bone level will be recorded at 6 months，12months and 18 months
The incidence of biological and mechanical complications
The incidence of biological and mechanical complications will be recorded at baseline, 6 months，12months and 18 months
Probing depth
Probing depth will be recorded at 6 months，12months and 18 months
Modified plaque index
Modified plaque index will be recorded at 6 months，12months and 18 months
Modified bleeding index
Modified bleeding index will be recorded at 6 months，12months and 18 months
Gingival index
Gingival index will be recorded at 6 months，12months and 18 months

Full Information

First Posted
May 4, 2016
Last Updated
August 15, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02772172
Brief Title
Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates
Official Title
Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GuideMia surgical template
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control surgical template
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Surgical Template
Other Intervention Name(s)
GuideMia, control
Primary Outcome Measure Information:
Title
Position changes between the planned and achieved implant position
Description
Accuracy analysis. The linear and angular deviations between the planned and achieved implant position are analyzed.
Time Frame
Change from preoperative to postoperative within 1 week
Secondary Outcome Measure Information:
Title
Implant and prosthesis survival
Description
Implant and prosthesis survival will be determined at 6 months，12months and 18 months
Time Frame
Up to 18 months after baseline
Title
Radiographic bone level
Description
Radiographic bone level will be recorded at 6 months，12months and 18 months
Time Frame
Up to 18 months after baseline
Title
The incidence of biological and mechanical complications
Description
The incidence of biological and mechanical complications will be recorded at baseline, 6 months，12months and 18 months
Time Frame
Up to 18 months after baseline
Title
Probing depth
Description
Probing depth will be recorded at 6 months，12months and 18 months
Time Frame
Up to 18 months after baseline
Title
Modified plaque index
Description
Modified plaque index will be recorded at 6 months，12months and 18 months
Time Frame
Up to 18 months after baseline
Title
Modified bleeding index
Description
Modified bleeding index will be recorded at 6 months，12months and 18 months
Time Frame
Up to 18 months after baseline
Title
Gingival index
Description
Gingival index will be recorded at 6 months，12months and 18 months
Time Frame
Up to 18 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuofan Chen, Professor
Phone
+86-20-83862537
Email
1330177020@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Liu
Phone
+8615902064014
Email
838667172@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuofan Chen, professor
Organizational Affiliation
School of Stomatology, Hospital of Stomatology, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuofan Chen, professor
Phone
＋8613902241868
Email
dentistczf@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25195544
Citation
Lopes A, Malo P, de Araujo Nobre M, Sanchez-Fernandez E. The NobelGuide(R) All-on-4(R) Treatment Concept for Rehabilitation of Edentulous Jaws: A Prospective Report on Medium- and Long-Term Outcomes. Clin Implant Dent Relat Res. 2015 Oct;17 Suppl 2:e406-16. doi: 10.1111/cid.12260. Epub 2014 Sep 5.
Results Reference
result
PubMed Identifier
24341829
Citation
Sun Y, Luebbers HT, Agbaje JO, Schepers S, Politis C, Van Slycke S, Vrielinck L. Accuracy of Dental Implant Placement Using CBCT-Derived Mucosa-Supported Stereolithographic Template. Clin Implant Dent Relat Res. 2015 Oct;17(5):862-70. doi: 10.1111/cid.12189. Epub 2013 Dec 16.
Results Reference
result
PubMed Identifier
23789721
Citation
Polizzi G, Cantoni T. Five-year follow-up of immediate fixed restorations of maxillary implants inserted in both fresh extraction and healed sites using the NobelGuide system. Clin Implant Dent Relat Res. 2015 Apr;17(2):221-33. doi: 10.1111/cid.12102. Epub 2013 Jun 23.
Results Reference
result

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

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