Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 13, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedAugust 17, 2016
May 1, 2016
1.3 years
May 4, 2016
August 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Change from preoperative to postoperative within 1 week
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
GuideMia surgical template
ACTIVE COMPARATORA 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
ACTIVE COMPARATORA 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.
Interventions
Eligibility Criteria
You may qualify if:
- Partial edentulism
- Missing more than three teeth in succession
- Presence of adjacent teeth
- Systemically healthy
- Good maxillomandibular relation
- Maximal mouth opening\>5 mm
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Related Publications (3)
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.
PMID: 25195544RESULTSun 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.
PMID: 24341829RESULTPolizzi 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.
PMID: 23789721RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhuofan Chen, professor
School of Stomatology, Hospital of Stomatology, Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 4, 2016
First Posted
May 13, 2016
Study Start
August 1, 2016
Primary Completion
November 1, 2017
Study Completion
February 1, 2018
Last Updated
August 17, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share