Edentulous Alveolar Ridge AtrophyNCT05282862
Guided Surgery for Horizontal Bone Augmentation
A study testing Horizontal bone augmentation in people with Edentulous Alveolar Ridge Atrophy, run by KU Leuven at 1 site in Belgium.
Trial summary
The aim of the research project is to develop a novel protocol for guided bone regeneration (GBR) and assess whether such a patient specific 3D printed guide can improve the accuracy of the resulting bone augmentation when compared to conventional freehand protocols. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Alveolar Ridge Atrophy
- What is being tested?
- Horizontal bone augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- 28 May 2019to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of at least one site requiring bone augmentation prior to or simultaneously with implant placement;
- the above mentioned site should have adjacent teeth both mesially and distally;
- a history of edentulism in the area of implant treatment of at least 3 months;
- provision of informed consent.
Who cannot join
- unlikely to be able to comply with the study procedures, as judged by the investigator;
- untreated periodontal disease;
- known or suspected current malignancy;
- history of chemotherapy within 5 years prior to study;
- history of radiation in the head and neck region;
- history of other metabolic bone diseases;
Show all 14Show fewer
- a medical history that makes bone augmentation or implant insertion unfavorable;
- need for systemic corticosteroids;
- current or previous use of intravenous bisphosphonates;
- current or previous use of oral bisphosphonates;
- history of bone grafting and/or sinus lift in the planned implant area;
- present alcohol and/or drug abuse;
- involvement in the planning and conduct of the study;
- previous enrolment in the present study.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven Sint Rafaël Campus
Leuven, 3000
Mihai Tarce, +32 16 332483, mihai.tarce@kuleuven.be
About this study
The aim of the research project is to develop a novel protocol for guided bone regeneration (GBR) and assess whether such a patient specific 3D printed guide can improve the accuracy of the resulting bone augmentation when compared to conventional freehand protocols.
This study will be an open, prospective, randomized controlled clinical trial. A total of 28 healthy adult patients requiring bone augmentation of an edentulous site with adjacent teeth prior to implant placement will be included in a clinical trial.
Read more
All patients have to fulfill all inclusion criteria and none of the exclusion criteria. The total study duration for the patient will be around 7 months, from inclusion to final follow-up.
A virtual plan representing the ideal shape of the augmentation will be prepared. Bone augmentation guides (molds) will be designed and 3D printed for each case. These molds will encompass the defect and the desired augmentation (including the overfill compensating for the expected resorption) on the buccal aspect, leaving a small access space on the coronal aspect of the defect which will be used to insert the grafting material. Additionally, they will have holes near the mesial, distal and apical edges allowing for fixation of the barrier membrane using pin placement when the mold is in position. Finally, they will extend to the occlusal surface of teeth adjacent to the defect site in order to allow precise positioning and will have a protrusion (handle) on the buccal aspect allowing for easier handling and positioning.
The trial will have two groups, a freehand group where conventional bone augmentation surgery will be performed and the clinician will determine the shape of the graft manually, and a guided group where the guide described above will be used. A 50:50 mixture of DBBM and autogenous bone will be used for both groups, resulting in a composite graft. The graft will be covered by a resorbable collagen membrane.
- Conditions
- Edentulous Alveolar Ridge Atrophy
- Being tested
- Horizontal bone augmentation
- Keywords
- implant, bone augmentation, GBR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizontal bone augmentationProcedure or surgery
Horizontal bone augmentation of a limited span (1-2 teeth) edentulous ridge with neighboring teeth present.
| Study group | Role | What they receive |
|---|---|---|
| Freehand | Active comparator | Conventional bone augmentation using a particulate graft material (DBBM) and a collagen barrier membrane. Receives: Procedure: Horizontal bone augmentation |
| Guided | Experimental | Bone augmentation performed using the materials as in the Freehand group, but using a surgical guide to help define the shape of the guide. Receives: Procedure: Horizontal bone augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of resulting graft, immediately post-operatively.
Linear and volumetric difference between plan and resulting graft, measured on the post-op CBCT.
Measured: Immediately after surgery
Accuracy of resulting graft, 6 months after surgery
Linear and volumetric difference between plan and resulting graft, measured on the CBCT taken 6 months after surgery.
Measured: Six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start28 May 2019
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar Ridge AtrophyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- ITI Foundation
- Responsible party
- Principal investigator, Mihai Tarce, KU Leuven
- Investigators
- Mihai Tarce, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282862
- Sponsor's protocol ID
- S61322
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Surgery for Horizontal Bone Augmentation
- ClinicalTrials.gov ID
- NCT05282862
- Acronym / sponsor ID
- S61322
- Conditions
- Edentulous Alveolar Ridge Atrophy
- Keywords
- implant, bone augmentation, GBR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- ITI Foundation
- Study start
- 28 May 2019 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 16 Mar 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.
The aim of the research project is to develop a novel protocol for guided bone regeneration (GBR) and assess whether such a patient specific 3D printed guide can improve the accuracy of the resulting bone augmentation when compared to conventional freehand protocols.
This study will be an open, prospective, randomized controlled clinical trial. A total of 28 healthy adult patients requiring bone augmentation of an edentulous site with adjacent teeth prior to implant placement will be included in a clinical trial.
All patients have to fulfill all inclusion criteria and none of the exclusion criteria. The total study duration for the patient will be around 7 months, from inclusion to final follow-up.
A virtual plan representing the ideal shape of the augmentation will be prepared. Bone augmentation guides (molds) will be designed and 3D printed for each case. These molds will encompass the defect and the desired augmentation (including the overfill compensating for the expected resorption) on the buccal aspect, leaving a small access space on the coronal aspect of the defect which will be used to insert the grafting material. Additionally, they will have holes near the mesial, distal and apical edges allowing for fixation of the barrier membrane using pin placement when the mold is in position. Finally, they will extend to the occlusal surface of teeth adjacent to the defect site in order to allow precise positioning and will have a protrusion (handle) on the buccal aspect allowing for easier handling and positioning.
The trial will have two groups, a freehand group where conventional bone augmentation surgery will be performed and the clinician will determine the shape of the graft manually, and a guided group where the guide described above will be used. A 50:50 mixture of DBBM and autogenous bone will be used for both groups, resulting in a composite graft. The graft will be covered by a resorbable collagen membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freehand | Active comparator | Procedure: Horizontal bone augmentationConventional bone augmentation using a particulate graft material (DBBM) and a collagen barrier membrane. |
| Guided | Experimental | Procedure: Horizontal bone augmentationBone augmentation performed using the materials as in the Freehand group, but using a surgical guide to help define the shape of the guide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- presence of at least one site requiring bone augmentation prior to or simultaneously with implant placement;
- the above mentioned site should have adjacent teeth both mesially and distally;
- a history of edentulism in the area of implant treatment of at least 3 months;
- provision of informed consent.
Key exclusion criteria (14 listed)
- unlikely to be able to comply with the study procedures, as judged by the investigator;
- untreated periodontal disease;
- known or suspected current malignancy;
- history of chemotherapy within 5 years prior to study;
- history of radiation in the head and neck region;
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 |
|---|---|---|
| Horizontal bone augmentationHorizontal bone augmentation of a limited span (1-2 teeth) edentulous ridge with neighboring teeth present. | Procedure or surgery | Freehand, Guided |
Primary outcome
Accuracy of resulting graft, immediately post-operatively.
Time frame: Immediately after surgery
Linear and volumetric difference between plan and resulting graft, measured on the post-op CBCT.
Accuracy of resulting graft, 6 months after surgery
Time frame: Six months after surgery
Linear and volumetric difference between plan and resulting graft, measured on the CBCT taken 6 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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.
Mihai Tarce principal investigator
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 Horizontal bone augmentation in people with Edentulous Alveolar Ridge Atrophy, run by 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 4 inclusion and 14 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 31 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mihai Tarce (+32 16 332483, mihai.tarce@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of resulting graft, immediately post-operatively. (time frame: Immediately after surgery). The study lists 2 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 31 Mar 2022.