- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05902715
The Socket Shield Technique, a Prospective Cohort Study of 20 Patients
The Socket Shield Technique: Stability of the Buccal Peri-implant Bone After Partial Root Removal - a Prospective Cohort Study of 20 Patients, With 18 Months Follow-up
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aims: This study aims to collect data on implant survival, bone volume maintenance, and complications associated with the socket shield technique.
Materials & methods: The study involved the placement of 23 implants using the socket shield technique in 20 patients. AstraTech EV implants were used, and no bone substitutes or connective tissue grafts were applied. Patients were monitored for 18 months, recording implant survival, volumetric bone analysis on CBCT scans, interproximal bone levels, bone sounding, pink esthetic scores, and complications. Prosthetic procedures were also described, including temporary and final restorations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium
- UZ Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Hopeless teeth suitable for immediate implant placement
- Only single-rooted teeth in the maxilla
- Intact buccal and palatal bone plate
- Intact buccal root portion
- Any periodontal phenotype (thin, thick)
Exclusion Criteria:
• Horizontal root fracture below bone level
- Smoking
- Systemic pathology influencing bone healing
- Active periodontal disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: oral implant placement with socket shield technique
cohort of 20 patients in need of tooth replacement with oral implant
|
tooth is split in socket shield configuration, implant is immediately placed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
buccal bone thickness
Time Frame: 18 months
|
thickness as measured on cbct scan
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative survival rate
Time Frame: 18 months
|
implant survival
|
18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rutger Dhondt, Universitaire Ziekenhuizen KU Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S59423
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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