Back to resultsMarginal Bone Loss in Single Implant Restaurations With Different Methods
Primary Purpose
Bone Loss
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Bti Unit
Sponsored by
About this trial
This is an interventional treatment trial for Bone Loss
Eligibility Criteria
Inclusion Criteria:
- patients with single implants restaurations treated in Leon University
Exclusion Criteria:
- pregnant
- mayor heath issues
- patients who do not agree to participate
Sites / Locations
- Universidad de Leon
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Overcast implant single restauration
Cad/cam direct implant restauration
Cad/cam implant restauration with transepithelial pilar
Arm Description
Outcomes
Primary Outcome Measures
Rate of marginal loss in single dental implants
To evaluate the vertical loss of bone in milimiters around the implant
Secondary Outcome Measures
Number of Implants with Prosthetic complications
The investigator is going to analyze if there is porcelain chipping (yes or not) and screw loosening (yes or not)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05301400
Brief Title
Marginal Bone Loss in Single Implant Restaurations With Different Methods
Official Title
Marginal Bone Loss in Single Implant Restaurations With Three Different Methods
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de León
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigator is going to measure the marginal bone loss in single implant restaurations with three different methods: direct overcast, milled cad/cam direct to implant restauration and milled cad/cam implant restauration using an transepithelial pilar
Detailed Description
The investigator has chosen a statistically significant sample (compared with other similar studies) to analize the bone marginal loss in different types of restauration with single dental implants
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Overcast implant single restauration
Arm Type
Active Comparator
Arm Title
Cad/cam direct implant restauration
Arm Type
Active Comparator
Arm Title
Cad/cam implant restauration with transepithelial pilar
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Bti Unit
Intervention Description
Comparison with or without the device
Primary Outcome Measure Information:
Title
Rate of marginal loss in single dental implants
Description
To evaluate the vertical loss of bone in milimiters around the implant
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Implants with Prosthetic complications
Description
The investigator is going to analyze if there is porcelain chipping (yes or not) and screw loosening (yes or not)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with single implants restaurations treated in Leon University
Exclusion Criteria:
pregnant
mayor heath issues
patients who do not agree to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus Seco
Organizational Affiliation
Universidad de León
Official's Role
Study Director
Facility Information:
Facility Name
Universidad de Leon
City
León
State/Province
Leon
ZIP/Postal Code
24071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Bone marginal loss
Learn more about this trial
Marginal Bone Loss in Single Implant Restaurations With Different Methods
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