Peri-implant HealthNCT05902715
The Socket Shield Technique, a Prospective Cohort Study of 20 Patients
A study testing oral implant placement with socket shield technique in people with Peri-implant Health, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
23 implants with socket shield were followed for 18 months. buccal bone thickness and survival rates registered. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peri-implant Health
- What is being tested?
- oral implant placement with socket shield technique
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Jun 2018to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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)
Who cannot join
- • Horizontal root fracture below bone level
- Smoking
- Systemic pathology influencing bone healing
- Active periodontal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
23 implants with socket shield were followed for 18 months. buccal bone thickness and survival rates registered.
Read the 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.
- Conditions
- Peri-implant Health
- Being tested
- oral implant placement with socket shield technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral implant placement with socket shield techniqueDevice
tooth is split in socket shield configuration, implant is immediately placed
| Study group | Role | What they receive |
|---|---|---|
| oral implant placement with socket shield technique | Experimental | cohort of 20 patients in need of tooth replacement with oral implant Receives: Device: oral implant placement with socket shield technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
buccal bone thickness
thickness as measured on cbct scan
Measured: 18 months
Secondary outcomes (1)
Cumulative survival rate
implant survival
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start18 Jun 2018
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant HealthStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Principal investigator, Ana CASTRO SARDA, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Rutger Dhondt, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902715
- Sponsor's protocol ID
- S59423
- Status last verified
- Jun 2023
- First submitted
- 30 May 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05902715
- Acronym / sponsor ID
- S59423
- Conditions
- Peri-implant Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral implant placement with socket shield technique | Experimental | Device: oral implant placement with socket shield techniquecohort of 20 patients in need of tooth replacement with oral implant |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Hopeless teeth suitable for immediate implant placement
Key exclusion criteria (4 listed)
- • Horizontal root fracture below bone level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral implant placement with socket shield techniquetooth is split in socket shield configuration, implant is immediately placed | Device | oral implant placement with socket shield technique |
Primary outcome
buccal bone thickness
Time frame: 18 months
thickness as measured on cbct scan
1 secondary outcome
Cumulative survival rate
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rutger Dhondt principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral implant placement with socket shield technique in people with Peri-implant Health, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
buccal bone thickness (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.