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

Jaw, Edentulous, Partially Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02772172
• Other study ID #: ZhuofanChen
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2016
• Last updated: August 15, 2016
• Start date: August 2016
• Est. completion date: February 2018

Study information

• Verified date: May 2016
• Source: Sun Yat-sen University
• Contact: Zhuofan Chen, Professor
• Phone: +86-20-83862537
• Email: 1330177020[@]qq.com
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Device:
• Surgical Template

Locations

Country	Name	City	State
China	Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

Lopes A, Maló P, de Araújo Nobre M, Sanchez-Fernández E. The NobelGuide® All-on-4® 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. d — View 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. Ep — View 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.121 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Implant and prosthesis survival	Implant and prosthesis survival will be determined at 6 months,12months and 18 months	Up to 18 months after baseline	No
Secondary	Radiographic bone level	Radiographic bone level will be recorded at 6 months,12months and 18 months	Up to 18 months after baseline	No
Secondary	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	No
Secondary	Probing depth	Probing depth will be recorded at 6 months,12months and 18 months	Up to 18 months after baseline	No
Secondary	Modified plaque index	Modified plaque index will be recorded at 6 months,12months and 18 months	Up to 18 months after baseline	No
Secondary	Modified bleeding index	Modified bleeding index will be recorded at 6 months,12months and 18 months	Up to 18 months after baseline	No
Secondary	Gingival index	Gingival index will be recorded at 6 months,12months and 18 months	Up to 18 months after baseline	No