Back to resultsImmediate Implant Outcomes With and Without Bone Augmentation
Primary Purpose
Tooth Loss, Bone Loss, Alveolar, Dental Diseases
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
implant placement
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Loss focused on measuring immediate dental implant, dental implant, bone regeneration, peri-implantitis
Eligibility Criteria
Inclusion Criteria:
- individuals 20 Years and older
- Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics.
- ASA1 or ASA2 (American Society of Anesthesiologists)
- Healthy individuals with good oral hygiene and motivation
- No systemic uncontrolled diseases
- Not taking drugs known to modify bone metabolism
Exclusion Criteria:
- Individuals with untreated & generalized severe periodontitis
- Smokers (>5 cigarettes/day)
- Poor oral hygiene
- Diabetes (HbA1C >6.5% as cutoff value)
- Uncontrolled cardiovascular disease
- Poor overall health (ASA IV)
Sites / Locations
- FV, DDS,Corp
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Immediate implant placement without reconstruction
Immediate implant placement with reconstruction
Arm Description
Immediate implant placement after tooth extraction
Immediate implant placement and simultaneous bone reconstruction after tooth extraction
Outcomes
Primary Outcome Measures
Evaluate implant placement feasibility & success rate at 12 months
evaluate implant success following Karoussis et al. success criteria
Number of individuals with low pink esthetic outcomes as assessed by pink esthetic scores (PES)
pink esthetics scores (PES) as proposed by Belser et al. Values 0-10 were 10 is the best esthetic outcome.
Secondary Outcome Measures
Implant transparency: clinical presence or absence
Visual evaluation of facial mucosal implant transparency at 12 months: positive or negative
Number of participants with >0.2mm of marginal bone levels
evaluate radiographic marginal bone levels at 12 months with >0.2mm of bone loss
Band of keratinized tissue: clinical presence or absence
evaluate the presence of facial keratinized tissue on the implant sites >2 or <2mm
Full Information
NCT ID
NCT05157009
First Posted
November 8, 2021
Last Updated
April 24, 2023
Sponsor
Verdugo, Fernando, DDS
1. Study Identification
Unique Protocol Identification Number
NCT05157009
Brief Title
Immediate Implant Outcomes With and Without Bone Augmentation
Official Title
Immediate Implants in Damaged Sockets With Simultaneous Bone Reconstruction vs. Immediate Implants in Intact Sockets and no Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Verdugo, Fernando, DDS
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
To evaluate immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement.
Detailed Description
The present clinical trial aims at demonstrating facial bone regeneration on sites that presented large buccal bone dehiscences & vertical bone loss and evaluate the feasibility of performing simultaneous bone augmentation and implant placement, comparing the outcomes with sites that had intact sockets that did not require reconstruction. A secondary objective was to evaluate pink esthetics and marginal bone levels at final follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss, Bone Loss, Alveolar, Dental Diseases, Dental Trauma
Keywords
immediate dental implant, dental implant, bone regeneration, peri-implantitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate implant placement without reconstruction
Arm Type
Other
Arm Description
Immediate implant placement after tooth extraction
Arm Title
Immediate implant placement with reconstruction
Arm Type
Other
Arm Description
Immediate implant placement and simultaneous bone reconstruction after tooth extraction
Intervention Type
Procedure
Intervention Name(s)
implant placement
Other Intervention Name(s)
bone reconstruction
Intervention Description
autogenous bone reconstruction of damaged socket & simultaneous implant placement
Primary Outcome Measure Information:
Title
Evaluate implant placement feasibility & success rate at 12 months
Description
evaluate implant success following Karoussis et al. success criteria
Time Frame
12 months
Title
Number of individuals with low pink esthetic outcomes as assessed by pink esthetic scores (PES)
Description
pink esthetics scores (PES) as proposed by Belser et al. Values 0-10 were 10 is the best esthetic outcome.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Implant transparency: clinical presence or absence
Description
Visual evaluation of facial mucosal implant transparency at 12 months: positive or negative
Time Frame
12 months
Title
Number of participants with >0.2mm of marginal bone levels
Description
evaluate radiographic marginal bone levels at 12 months with >0.2mm of bone loss
Time Frame
12 months
Title
Band of keratinized tissue: clinical presence or absence
Description
evaluate the presence of facial keratinized tissue on the implant sites >2 or <2mm
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
individuals 20 Years and older
Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics.
ASA1 or ASA2 (American Society of Anesthesiologists)
Healthy individuals with good oral hygiene and motivation
No systemic uncontrolled diseases
Not taking drugs known to modify bone metabolism
Exclusion Criteria:
Individuals with untreated & generalized severe periodontitis
Smokers (>5 cigarettes/day)
Poor oral hygiene
Diabetes (HbA1C >6.5% as cutoff value)
Uncontrolled cardiovascular disease
Poor overall health (ASA IV)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verdugo, PhD
Organizational Affiliation
Verdugo, Fernando, DDS
Official's Role
Principal Investigator
Facility Information:
Facility Name
FV, DDS,Corp
City
San Gabriel
State/Province
California
ZIP/Postal Code
91776
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immediate Implant Outcomes With and Without Bone Augmentation
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