Back to resultsSoft and Hard Tissues Evaluation Around Immediately Placed New Implant Design
Primary Purpose
Peri-implant Mucositis, Dental Implant Failed
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
platform switching
platform amtching
Sponsored by
About this trial
This is an interventional prevention trial for Peri-implant Mucositis focused on measuring platform switched implants, platform matched implants
Eligibility Criteria
Inclusion Criteria:
- good health
- unrestorable, periodontal healthy teeth
Exclusion Criteria:
- systemic disease
- periodontal disease
- presence of abscess
Sites / Locations
- faculty of dentistry, kafrelsheikh University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Maxi-Z plus dental implant
Maxi-Z dental implant
Arm Description
platform switched dental implants
platform matched dental implants
Outcomes
Primary Outcome Measures
Implant mobility using Periotest M
Periotest M values range from (-8 to 0). high values represent loose implant, while osseointegrated implants showed low values
marginal bone level
measured in mm using X-ray
Secondary Outcome Measures
pink estheic score
from 0-12. 0 means bad aesthetic of soft tissue. 12 means the ultimate aesthetics of soft tissue
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04905758
Brief Title
Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design
Official Title
Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design: Randomised Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
June 9, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
patients were randomly divided into Maxi-Z plus dental implant group versus Maxi-Z implant group
Detailed Description
after tooth extraction implants will be placed immediately and provisional restoration will be placed in both groups to detect the advantaged and drawbacks of newly designed Maxi-Z plus dental implant versus Maxi-Z dental implant
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis, Dental Implant Failed
Keywords
platform switched implants, platform matched implants
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Maxi-Z plus dental implant
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maxi-Z plus dental implant
Arm Type
Experimental
Arm Description
platform switched dental implants
Arm Title
Maxi-Z dental implant
Arm Type
Active Comparator
Arm Description
platform matched dental implants
Intervention Type
Procedure
Intervention Name(s)
platform switching
Intervention Description
reduced implant abutment interface
Intervention Type
Procedure
Intervention Name(s)
platform amtching
Intervention Description
matched implant abutment interface
Primary Outcome Measure Information:
Title
Implant mobility using Periotest M
Description
Periotest M values range from (-8 to 0). high values represent loose implant, while osseointegrated implants showed low values
Time Frame
12 months
Title
marginal bone level
Description
measured in mm using X-ray
Time Frame
12 months
Secondary Outcome Measure Information:
Title
pink estheic score
Description
from 0-12. 0 means bad aesthetic of soft tissue. 12 means the ultimate aesthetics of soft tissue
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
good health
unrestorable, periodontal healthy teeth
Exclusion Criteria:
systemic disease
periodontal disease
presence of abscess
Facility Information:
Facility Name
faculty of dentistry, kafrelsheikh University
City
Kafr Ash Shaykh
State/Province
Kafrelsheikh
ZIP/Postal Code
214312
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
after research results publishing will decide
IPD Sharing Time Frame
by the end of August 2021 for 6 months
IPD Sharing Access Criteria
open access
Learn more about this trial
Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design
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