Back to resultsAccuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients
Primary Purpose
Edentulous Jaw
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dynamic navigation
Static template
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Jaw
Eligibility Criteria
Inclusion Criteria: 18 years old and above American society of anesthesiologists (ASA) Levels 1 and 2 Satisfy any of the following requirements: Edentulous maxillary patients Edentulous mandibular patients Terminally edentulous maxillary patients (number of remaining natural teeth in the upper jaw 1-4) Terminally edentulous mandibular patients (number of remaining natural teeth in the lower jaw 1-4) Full-mouth edentulous patients Full-mouth terminally edentulous patients (number of remaining natural teeth in one jaw 1-4) Implant-supported fixed restorations or implant-supported overdenture restorations Sufficient usable bone volume at implant sites, non-implant sites (≥1.5mm of remaining bone width on the labial/buccal and palatal/lingual sides after virtual implant placement in software) Maxillary and mandibular options for full-mouth patients are based on the inclusion of more single jaws in the non-bone grafted sites (see virtual peri-implant bone volume requirements in the pre-operative preparation phase) Mouth opening of 3 fingers or more Single-jawed missing patients treated with systemic periodontal therapy Exclusion Criteria: Have a systemic disease that may affect prognosis (e.g. diabetic patients with glycated haemoglobin >6.5%, patients on bisphosphonate medication, patients with auto-systemic immune diseases, etc.) ASA grades 3 and 4 Acute inflammation in the oral cavity: including uncontrolled periodontitis (periodontal probing depth > 4 mm) and untreated acute and chronic apical periodontitis Pregnancy or breastfeeding History of radiotherapy to the head and neck Heavy smokers (more than 10 cigarettes per day) Restricted mouth opening (less than three fingers). Participation in a clinical trial with another drug or device within 30 days prior to the start of the procedure (study day 0).
Sites / Locations
- Shanghai Ninth People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dynamic navigation
Static template
Arm Description
Outcomes
Primary Outcome Measures
Apical deviation of implant placement (mm)
Preoperative planning and postoperative cone-beam computed tomography (CBCT) were aligned together in the software and apical deviations(mm) of implant placement were measured to compare the results of the two groups.
Secondary Outcome Measures
Coronal deviation of implant placement (mm)
Preoperative planning and postoperative CBCT were aligned together in the software and coronal deviations(mm) of implant placement were measured to compare the results of the two groups.
Angular deviation of implant placement (°)
Preoperative planning and postoperative CBCT were aligned together in the software and angular deviations(°) of implant placement were measured to compare the results of the two groups.
Operation time
From anaesthesia to all implants are placed
Implant stability quotient
Implant stability quotient was measured with the Osstell®device
visual analogue scale
Patients were asked how they felt about the procedure using a visual analogue scale (VAS), which was measured using a visual analogue scale from 0 to 10. On a scale of 0 to 10 ("no pain" 0 to "maximum pain" 10) ("very comfortable" 0 to "not at all comfortable" 10) ("no swelling" 0 to "severe swelling" 10)
Failure rate
Failure rate of implants during the healing period
Change of marginal bone level(mm)
Marginal bone level = Measurement of the distance (mm) between the reference point (shoulder of the implant) and the point of bone-implant contact on the periapical film ; Change of marginal bone level = marginal bone level in the follow-up period - marginal bone level in the baseline period (mm)
Full Information
NCT ID
NCT06051266
First Posted
September 3, 2023
Last Updated
September 20, 2023
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT06051266
Brief Title
Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients
Official Title
Clinical Accuracy Evaluation of Dynamic Navigation and Static Template for Dental Implant Placement in Completely Edentulous Patients: A Randomized Parallel Controlled Multicenter Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study was a prospective, multicentre, randomized parallel controlled clinical trial. Randomisation was conducted by central randomisation, with random allocation codes generated by the main central computer. Enrollment was conducted by competition between different centres. In this study, the coronal, apical and angular deviations (mean, standard deviation, median, quartiles, minimum, maximum, 95% confidence interval) of the static template and dynamic navigation group guided implant placement were calculated. The data is proposed to be analysed using a mixed linear effects model.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaw
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dynamic navigation
Arm Type
Experimental
Arm Title
Static template
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Dynamic navigation
Intervention Description
Dynamic navigation eliminates the need for a laboratory fabrication process and allows for direct visualisation of the operative area during implant placement. Moreover, it can avoid interfering with water cooling. Navigation-assisted surgery makes it possible to modify the implant system, length, diameter or position in real time, both in the perioperative period and during surgery.
Intervention Type
Device
Intervention Name(s)
Static template
Intervention Description
In most clinical situations, a static template can be used to assist in guiding the placement of implants precisely. The static guide has some limitations in that it requires additional fabrication time, has insufficient cooling in the surgical field and is not suitable for simultaneous grafting procedures.
Primary Outcome Measure Information:
Title
Apical deviation of implant placement (mm)
Description
Preoperative planning and postoperative cone-beam computed tomography (CBCT) were aligned together in the software and apical deviations(mm) of implant placement were measured to compare the results of the two groups.
Time Frame
About 3 days after surgery
Secondary Outcome Measure Information:
Title
Coronal deviation of implant placement (mm)
Description
Preoperative planning and postoperative CBCT were aligned together in the software and coronal deviations(mm) of implant placement were measured to compare the results of the two groups.
Time Frame
About 3 days after surgery
Title
Angular deviation of implant placement (°)
Description
Preoperative planning and postoperative CBCT were aligned together in the software and angular deviations(°) of implant placement were measured to compare the results of the two groups.
Time Frame
About 3 days after surgery
Title
Operation time
Description
From anaesthesia to all implants are placed
Time Frame
Surgery day
Title
Implant stability quotient
Description
Implant stability quotient was measured with the Osstell®device
Time Frame
Surgery day
Title
visual analogue scale
Description
Patients were asked how they felt about the procedure using a visual analogue scale (VAS), which was measured using a visual analogue scale from 0 to 10. On a scale of 0 to 10 ("no pain" 0 to "maximum pain" 10) ("very comfortable" 0 to "not at all comfortable" 10) ("no swelling" 0 to "severe swelling" 10)
Time Frame
About 3 days after surgery
Title
Failure rate
Description
Failure rate of implants during the healing period
Time Frame
About 4 months after surgery
Title
Change of marginal bone level(mm)
Description
Marginal bone level = Measurement of the distance (mm) between the reference point (shoulder of the implant) and the point of bone-implant contact on the periapical film ; Change of marginal bone level = marginal bone level in the follow-up period - marginal bone level in the baseline period (mm)
Time Frame
About 1 year after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years old and above
American society of anesthesiologists (ASA) Levels 1 and 2
Satisfy any of the following requirements:
Edentulous maxillary patients
Edentulous mandibular patients
Terminally edentulous maxillary patients (number of remaining natural teeth in the upper jaw 1-4)
Terminally edentulous mandibular patients (number of remaining natural teeth in the lower jaw 1-4)
Full-mouth edentulous patients
Full-mouth terminally edentulous patients (number of remaining natural teeth in one jaw 1-4)
Implant-supported fixed restorations or implant-supported overdenture restorations
Sufficient usable bone volume at implant sites, non-implant sites (≥1.5mm of remaining bone width on the labial/buccal and palatal/lingual sides after virtual implant placement in software)
Maxillary and mandibular options for full-mouth patients are based on the inclusion of more single jaws in the non-bone grafted sites (see virtual peri-implant bone volume requirements in the pre-operative preparation phase)
Mouth opening of 3 fingers or more
Single-jawed missing patients treated with systemic periodontal therapy
Exclusion Criteria:
Have a systemic disease that may affect prognosis (e.g. diabetic patients with glycated haemoglobin >6.5%, patients on bisphosphonate medication, patients with auto-systemic immune diseases, etc.)
ASA grades 3 and 4
Acute inflammation in the oral cavity: including uncontrolled periodontitis (periodontal probing depth > 4 mm) and untreated acute and chronic apical periodontitis
Pregnancy or breastfeeding
History of radiotherapy to the head and neck
Heavy smokers (more than 10 cigarettes per day)
Restricted mouth opening (less than three fingers).
Participation in a clinical trial with another drug or device within 30 days prior to the start of the procedure (study day 0).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinyan Chen
Phone
+86 15652440777
Email
15652440777@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiqun Wu
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinyan Chen
Phone
+86 15652440777
12. IPD Sharing Statement
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Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients
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