Socket Shield Technique Versus Early Implant Placement With Contour Augmentation
Primary Purpose
Bone Loss, Bone Resorption
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
contour augmentation
Sponsored by
About this trial
This is an interventional treatment trial for Bone Loss
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.
- Type I socket
- ≥18 years
- ≤ 60 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
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
socket shield technique
contour augmentation
Arm Description
immediate implant placement with socket shield technique
early implant placement with contour bone augmentation
Outcomes
Primary Outcome Measures
facial bone thickness
using superimposed CBCT images
Secondary Outcome Measures
facial bone height changes
using superimposed CBCT images
Soft tissue height changes
using superimposed intraoral scans
Full Information
NCT ID
NCT05261334
First Posted
January 28, 2022
Last Updated
March 11, 2022
Sponsor
Iman Abd-ElWahab Radi, PhD
1. Study Identification
Unique Protocol Identification Number
NCT05261334
Brief Title
Socket Shield Technique Versus Early Implant Placement With Contour Augmentation
Official Title
Socket Shielding in Immediate Versus Early Implant Placement With Contour Augmentation of Fresh Extraction Sockets in the Esthetic Zone. A Randomized Pilot Clinical Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 31, 2022 (Anticipated)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Iman Abd-ElWahab Radi, PhD
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
comparing socket shield technique with early implant placement with contour augmentation in preserving the bone contour
Detailed Description
comparing immediate implant placement with socket shield technique and final crown after 3 months with extraction and after 4 to 8 weeks implant placement with contour bone augmentation then after 3 to 4 months final crown delivery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Bone Resorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
socket shield technique
Arm Type
Active Comparator
Arm Description
immediate implant placement with socket shield technique
Arm Title
contour augmentation
Arm Type
Active Comparator
Arm Description
early implant placement with contour bone augmentation
Intervention Type
Procedure
Intervention Name(s)
contour augmentation
Intervention Description
early implant placement with contour bone augmentation
Primary Outcome Measure Information:
Title
facial bone thickness
Description
using superimposed CBCT images
Time Frame
12 months
Secondary Outcome Measure Information:
Title
facial bone height changes
Description
using superimposed CBCT images
Time Frame
12 months
Title
Soft tissue height changes
Description
using superimposed intraoral scans
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Type I socket
≥18 years
≤ 60 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.
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11553
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
iman abdelwahab radi, PHD
Phone
01001539613
Ext
002
Email
iman.abdelwahab@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Amir alaa Elawady, BDS
Phone
01020205791
Email
Amir112093@miuegypt.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Socket Shield Technique Versus Early Implant Placement With Contour Augmentation
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