The Socket Shield Technique, a Prospective Cohort Study o... | NCT05902715

Studies
The Socket Shield Technique, a Prospective Cohort Study of 20 Patients

NCT05902715

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Sep 5, 2025Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Peri-implant Health

Interventions

oral implant placement with socket shield technique

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2018Actual

Primary Completion Date

Jan 10, 2023Actual

Completion Date

Jan 10, 2023Actual

First Submitted Date

May 30, 2023

First Submission Date that Met QC Criteria

Jun 13, 2023

First Posted Date

Jun 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2025

Last Update Posted Date

Sep 5, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ana CASTRO SARDA, Clinical professor, head of periodontology department, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Name	Class
Dentsply Sirona Implants and Consumables	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

23 implants with socket shield were followed for 18 months. buccal bone thickness and survival rates registered.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
oral implant placement with socket shield technique	Experimental	cohort of 20 patients in need of tooth replacement with oral implant	Device: oral implant placement with socket shield technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral implant placement with socket shield technique	Device	tooth is split in socket shield configuration, implant is immediately placed	oral implant placement with socket shield technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
buccal bone thickness	thickness as measured on cbct scan	18 months

Secondary Outcomes

Measure	Description	Time Frame
Cumulative survival rate	implant survival	18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rutger Dhondt	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Leuven			Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057893	Immediate Dental Implant Loading

Ancestor Terms

ID	Term
D003758	Dental Implantation, Endosseous
D003757	Dental Implantation
D013516	Oral Surgical Procedures, Preprosthetic
D019647	Oral Surgical Procedures

Browse Leaves

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Browse Branches

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