Clinical trial NCT02772172: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Position changes between the planned and achieved implant position
timeFrame: Change from preoperative to postoperative within 1 week
Secondary outcomes:
measure: Implant and prosthesis survival
timeFrame: Up to 18 months after baseline
measure: Radiographic bone level
timeFrame: Up to 18 months after baseline
measure: The incidence of biological and mechanical complications
timeFrame: Up to 18 months after baseline
measure: Probing depth
timeFrame: Up to 18 months after baseline
measure: Modified plaque index
timeFrame: Up to 18 months after baseline
measure: Modified bleeding index
timeFrame: Up to 18 months after baseline
measure: Gingival index
timeFrame: Up to 18 months after baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: School of Stomatology, Hospital of Stomatology, Sun Yat-Sen University
name: Zhuofan Chen, professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.