Back to resultsVestibular Socket Therapy With Simultaneous Implant Placement Versus Contour Augmentation With Early Implant Placement
Primary Purpose
Loss of Teeth Due to Extraction
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
immediate implant
Sponsored by
About this trial
This is an interventional treatment trial for Loss of Teeth Due to Extraction
Eligibility Criteria
Inclusion Criteria:
Non-restorable maxillary teeth in the esthetic zone
Intact adjacent teeth
Adequate palatal and apical bone that allows achieving implant primary stability.
Compromised sockets type II defect (Nicolas Elian 2007)
≥18 years
Systemically healthy patients
Exclusion Criteria:
Extraction sockets with acute or chronic infection or with adjacent infected teeth
Heavy Smokers > than 10 cigarettes daily
Cancer patients undergoing radiotherapy or chemotherapy during or within the last 6 months.
Unmotivated patients to maintain adequate oral hygiene to follow up.
Patients with physical disabilities that could affect follow up.
Sites / Locations
- Faculty of dentistry Cairo university
- Faculty of dentistry
- Iman AbdelWahab Radi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
vestibuler socket therapy
contour augmentation
Arm Description
immediate implant placement in esthatic zone with final crown placement after 2 months with VST technique
Early implant placement in esthatic zone with contour augmentation and final crown after 3 months of implant placement
Outcomes
Primary Outcome Measures
Implant survival
If there is no pain or tenderness on use, no mobility, no history of exudates and radiographic bone loss is less than 2 mm from initial surgery implant the implant is considered successful
Secondary Outcome Measures
Changes in the height and thickness of the labial plate of bone
will be measured by superimposing CBCT images obtained at the baseline (time of tooth extraction) and those after 12 months postimplant placement.
Changes in soft tissue height
were identified midfacially and at the apex of the mesial and distal papillae by superimposing the STL (Standard Triangle Language) files of the models, obtained via IOS, at the baseline (of the unrestorable tooth) with those after 12 months of implant insertion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05005585
Brief Title
Vestibular Socket Therapy With Simultaneous Implant Placement Versus Contour Augmentation With Early Implant Placement
Official Title
Vestibular Socket Therapy With Simultaneous Implant Placement Versus Contour Augmentation With Early Implant Placement in Fresh Extraction Sockets : A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
immediate implant placement with VST technique versus early implant placement with contour augmentation in fresh extraction sockets in the esthetic zone.
Detailed Description
comparing VST technique with immediate implant placement that end up with final crown after 2 months with contour augmentation with early implant placement after 4- 8 weeks of soft tissue healing , then after 3 months final crown delivery both in fresh extraction sockets in the esthetic zone .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loss of Teeth Due to Extraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
VST with immediate implant placement versus contour augmentation with early implant placement in fresh extraction sockets in esthetic zone.
Masking
Outcomes Assessor
Masking Description
outcome assessor isnt involved in the intervension
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vestibuler socket therapy
Arm Type
Experimental
Arm Description
immediate implant placement in esthatic zone with final crown placement after 2 months with VST technique
Arm Title
contour augmentation
Arm Type
Experimental
Arm Description
Early implant placement in esthatic zone with contour augmentation and final crown after 3 months of implant placement
Intervention Type
Procedure
Intervention Name(s)
immediate implant
Intervention Description
immediate implant placement with VST technique versus early implant placement with contour augmentation technique
Primary Outcome Measure Information:
Title
Implant survival
Description
If there is no pain or tenderness on use, no mobility, no history of exudates and radiographic bone loss is less than 2 mm from initial surgery implant the implant is considered successful
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in the height and thickness of the labial plate of bone
Description
will be measured by superimposing CBCT images obtained at the baseline (time of tooth extraction) and those after 12 months postimplant placement.
Time Frame
12 months
Title
Changes in soft tissue height
Description
were identified midfacially and at the apex of the mesial and distal papillae by superimposing the STL (Standard Triangle Language) files of the models, obtained via IOS, at the baseline (of the unrestorable tooth) with those after 12 months of implant insertion
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-restorable maxillary teeth in the esthetic zone
Intact adjacent teeth
Adequate palatal and apical bone that allows achieving implant primary stability.
Compromised sockets type II defect (Nicolas Elian 2007)
≥18 years
Systemically healthy patients
Exclusion Criteria:
Extraction sockets with acute or chronic infection or with adjacent infected teeth
Heavy Smokers > than 10 cigarettes daily
Cancer patients undergoing radiotherapy or chemotherapy during or within the last 6 months.
Unmotivated patients to maintain adequate oral hygiene to follow up.
Patients with physical disabilities that could affect follow up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amir elawady, BDS
Phone
00201020205791
Email
amir112093@miuegypt.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Elkhashab, PHD
Phone
00201006611525
Email
mohamed.elkhashab@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iman Radi, PHD
Organizational Affiliation
Professor of prosthodontics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
AbdelSalam ElAsakry, BDS
Organizational Affiliation
Private Practice
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of dentistry Cairo university
City
Cairo
State/Province
Giza
ZIP/Postal Code
11865
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amir alaa elawady, BDS
Phone
00201020205791
Email
amir112093@miuegypt.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohamed Amr Elkhashab, PHD
Phone
01006611525
Email
mohamed.elkhashab@dentistry.cu.edu.eg
Facility Name
Faculty of dentistry
City
Cairo
State/Province
Manial
ZIP/Postal Code
12911
Country
Egypt
Facility Name
Iman AbdelWahab Radi
City
Cairo
ZIP/Postal Code
11518
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Vestibular Socket Therapy With Simultaneous Implant Placement Versus Contour Augmentation With Early Implant Placement
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