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Status unknownNCT02772172Updated Aug 17, 2016

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

An interventional study of Surgical Template in Jaw, Edentulous, Partially, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-17.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Jaw, Edentulous, Partially
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In context

Jaw, Edentulous

171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.

This study's planned enrollment of 30 is close to the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceSurgical Template

    Also known as: GuideMia, control

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What researchers measure

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.

    Time frame: Change from preoperative to postoperative within 1 week

Secondary outcomes

  1. Implant and prosthesis survival

    Implant and prosthesis survival will be determined at 6 months，12months and 18 months

    Time frame: Up to 18 months after baseline

  2. Radiographic bone level

    Radiographic bone level will be recorded at 6 months，12months and 18 months

    Time frame: Up to 18 months after baseline

  3. 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

    Time frame: Up to 18 months after baseline

  4. Probing depth

    Probing depth will be recorded at 6 months，12months and 18 months

    Time frame: Up to 18 months after baseline

  5. Modified plaque index

    Modified plaque index will be recorded at 6 months，12months and 18 months

    Time frame: Up to 18 months after baseline

  6. Modified bleeding index

    Modified bleeding index will be recorded at 6 months，12months and 18 months

    Time frame: Up to 18 months after baseline

  7. Gingival index

    Gingival index will be recorded at 6 months，12months and 18 months

    Time frame: Up to 18 months after baseline

07

Study locations

1 of 1 sites recruiting
  • Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25195544 ↗
  • 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. PubMed 24341829 ↗
  • 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. PubMed 23789721 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02772172
Lead sponsor
Sun Yat-sen University
Responsible party
Zhuofan Chen (professor, Sun Yat-sen University) — Principal investigator
First posted
May 13, 2016
Start date
Aug 2016
Primary completion
Nov 2017 (estimated)
Completion
Feb 2018 (estimated)
Last update
Aug 17, 2016

Study contacts

Zhuofan Chen, Professor
Contact
1330177020@qq.com
+86-20-83862537
Xin Liu
Contact
838667172@163.com
+8615902064014
Zhuofan Chen, professor
principal investigator · School of Stomatology, Hospital of Stomatology, Sun Yat-Sen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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