Bone AugmentationNCT05339971
Modified Surgical Technique for Lateral Block Augmentation Prior to Implant Installation
A study testing block perforation in people with Bone Augmentation, run by Medical University of Vienna.
Trial summary
Evaluation of the surgical result (augmentation volume, proportion of newly formed bone) after perforation of the bone block in the course of lateral block augmentation prior to planned implant installation. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Bone Augmentation
- What is being tested?
- block perforation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2016to Dec 2024
- 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single tooth gap in need of lateral bone augmentation prior to implant installation
Who cannot join
- untreated periodontal disease
- systemic disease and/or medication intake with significant effect on bone healing
About this study
Official title: Modified Surgical Technique for Lateral Block Augmentation Prior to Implant Installation - A Pilot Study on 10 Patients With Histological Assessment
Evaluation of the surgical result (augmentation volume, proportion of newly formed bone) after perforation of the bone block in the course of lateral block augmentation prior to planned implant installation.
- Conditions
- Bone Augmentation
- Being tested
- block perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
block perforationOther
The bone block used for lateral bone augmentation will be perforated several times.
| Study group | Role | What they receive |
|---|---|---|
| block perforation | Experimental | Not described Receives: Other: block perforation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometry
% of new bone formation
Measured: at implant installation (approximately 6 months after augmentation)
Radiographic
Volume gain (mm3) after block augmentation at the buccal aspect
Measured: 6 months after block augmentation
Radiographic
Volume gain (mm3) after block augmentation at the buccal aspect
Measured: 12 months after block augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start7 Dec 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone AugmentationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Bertl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339971
- Sponsor's protocol ID
- 1401/2016
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Surgical Technique for Lateral Block Augmentation Prior to Implant Installation - A Pilot Study on 10 Patients With Histological Assessment
- ClinicalTrials.gov ID
- NCT05339971
- Acronym / sponsor ID
- 1401/2016
- Conditions
- Bone Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Apr 2022 (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.
Evaluation of the surgical result (augmentation volume, proportion of newly formed bone) after perforation of the bone block in the course of lateral block augmentation prior to planned implant installation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| block perforation | Experimental | Other: block perforation |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- single tooth gap in need of lateral bone augmentation prior to implant installation
Key exclusion criteria (2 listed)
- untreated periodontal disease
- systemic disease and/or medication intake with significant effect on bone healing
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 |
|---|---|---|
| block perforationThe bone block used for lateral bone augmentation will be perforated several times. | Other | block perforation |
Primary outcome
Histomorphometry
Time frame: at implant installation (approximately 6 months after augmentation)
% of new bone formation
Radiographic
Time frame: 6 months after block augmentation
Volume gain (mm3) after block augmentation at the buccal aspect
Radiographic
Time frame: 12 months after block augmentation
Volume gain (mm3) after block augmentation at the buccal aspect
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing block perforation in people with Bone Augmentation, run by Medical University of Vienna.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Histomorphometry (time frame: at implant installation (approximately 6 months after augmentation)). The study lists 3 primary outcomes in all. 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 21 Apr 2022.