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

Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates: a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Jaw, Edentulous, Partially
• Intervention / Treatment: Device: Surgical Template

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin Liu; Phone Number: +8615902064014; Email: 838667172@163.com
• Study Contact Backup: Name: Zhuofan Chen, Professor; Phone Number: +86-20-83862537; Email: 1330177020@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University
      • Contact: Zhuofan Chen, professor; Phone Number: ＋8613902241868; Email: dentistczf@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: control; GuideMia
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: control; GuideMia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant and prosthesis survival	Implant and prosthesis survival will be determined at 6 months，12months and 18 months	Up to 18 months after baseline
Radiographic bone level	Radiographic bone level will be recorded at 6 months，12months and 18 months	Up to 18 months after baseline
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	Up to 18 months after baseline
Probing depth	Probing depth will be recorded at 6 months，12months and 18 months	Up to 18 months after baseline
Modified plaque index	Modified plaque index will be recorded at 6 months，12months and 18 months	Up to 18 months after baseline
Modified bleeding index	Modified bleeding index will be recorded at 6 months，12months and 18 months	Up to 18 months after baseline
Gingival index	Gingival index will be recorded at 6 months，12months and 18 months	Up to 18 months after baseline

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Zhuofan Chen, professor, School of Stomatology, Hospital of Stomatology, Sun Yat-Sen University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (Estimate): May 13, 2016

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous; Jaw, Edentulous, Partially
• Other Study ID Numbers: ZhuofanChen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO