Alveolar Bone ResorptionNCT06317090
Vertical GBR LPRF Block vs. Autogenous Bone With DBBM
A study testing guided bone regeneration in people with Alveolar Bone Resorption, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
split-mouth RCT, 25 months follow up. GBR protocol with LPRF as grafting material in the test group and autogenous bone with DBBM as grafting material in the control group. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- guided bone regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jul 2018to 1 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females, with ASA I or II, between 18 and 80 years old
- 2 implant sites requiring vertical bone augmentation prior to implant placement
- Both sites in the same jaw
- Good general health as documented by self-assessment
Who cannot join
- Any systemic medical condition that could interfere with the surgical procedure, planned treatment or healing of the patient
- Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
- Current pregnancy or breast feeding/ lactating at the time of recruitment.
- Radiotherapy or Chemotherapy in head and neck area.
- Intravenous and oral bisphosphonate therapy.
- Smoking
Show all 12Show fewer
- Unwillingness to return for the follow-up examination.
- Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations
- Presence of osseous pathologies, that might interfere with normal wound healing
- Presence of oral lesions (such as ulceration, malignancy)
- Local inflammation, including untreated periodontitis
- Patients with inadequate oral hygiene or unmotivated for adequate home care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vertical Guided Bone Regeneration: LPRF Block vs a Mixture of Autogenous Bone With Deproteinized Bovine Bone Mineral. A Split-mouth RCT Study With 25 Months Follow-up
split-mouth RCT, 25 months follow up. GBR protocol with LPRF as grafting material in the test group and autogenous bone with DBBM as grafting material in the control group.
Read the detailed description
6 patients were included in this split-mouth RCT. In control sites a horizontal GBR procedure was performed using a titanium reinforced dPTFE membrane with a graft consisting of 50% autogenous bone and 50% DBBM. In test sites a titanium reinforced dPTFE membrane was used, with a graft consisting of an LPRF block. This was left to heal for 9 months. Subsequently an implant was placed. At time of implant placement a bone biopsy was taken. After 4 months of osseointegration the abutment connection was performed. 1 year after loading of the implants a final check was done. CBCT scans were taken at intake, immediately after reconstruction, 9 months after reconstruction, before implant placement and 1 year after loading of the implants.
Primary outcome measure is the bone volume as measured on the CBCT scans. Secondary outcome measures are bone quality in the biopsy, buccal bone thickness around the oral implant, number and type of complications, cumulative survival rates of the implants 1 year after loading.
- Conditions
- Alveolar Bone Resorption
- Being tested
- guided bone regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided bone regenerationProcedure or surgery
Also called GBR
a non-resorbable membrane was used as a space maintainer, filled with a particulated bone graft.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | LPRF block as a grafting material Receives: Procedure: guided bone regeneration |
| Control | Experimental | 50% autogenous bone, 50% DBBM as a grafting material Receives: Procedure: guided bone regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone volume as measured on CBCT scans
CBCT scans taken and software used for measurement
Measured: CBCT scans at intake, with follow-up until 25 months post-operative
Secondary outcomes (4)
Buccal bone thickness around the implants
Bone thickness measured on CBCT scans
Measured: CBCT scans at placement of the implant and 1 year after loading of the implant
Buccal bone thickness around the implants
Bone thickness measured on CBCT scans
Measured: CBCT scans at 1 year after loading of the implant
Cumulative survival rate of the implants
Implants followed for 1 year after loading and survival recorded
Measured: 16 months of follow-up
rates and types of complications
All complications recorded during 25 months follow-up
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start2 Jul 2018
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone ResorptionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- split-mouth 2 arm RCT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana CASTRO SARDA, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317090
- Sponsor's protocol ID
- S59813-2
- Status last verified
- Mar 2024
- First submitted
- 6 Jun 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all info available on request
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertical Guided Bone Regeneration: LPRF Block vs a Mixture of Autogenous Bone With Deproteinized Bovine Bone Mineral. A Split-mouth RCT Study With 25 Months Follow-up
- ClinicalTrials.gov ID
- NCT06317090
- Acronym / sponsor ID
- S59813-2
- Conditions
- Alveolar Bone Resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 19 Mar 2024 (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.
split-mouth RCT, 25 months follow up. GBR protocol with LPRF as grafting material in the test group and autogenous bone with DBBM as grafting material in the control group.
Detailed description
6 patients were included in this split-mouth RCT. In control sites a horizontal GBR procedure was performed using a titanium reinforced dPTFE membrane with a graft consisting of 50% autogenous bone and 50% DBBM. In test sites a titanium reinforced dPTFE membrane was used, with a graft consisting of an LPRF block. This was left to heal for 9 months. Subsequently an implant was placed. At time of implant placement a bone biopsy was taken. After 4 months of osseointegration the abutment connection was performed. 1 year after loading of the implants a final check was done. CBCT scans were taken at intake, immediately after reconstruction, 9 months after reconstruction, before implant placement and 1 year after loading of the implants.
Primary outcome measure is the bone volume as measured on the CBCT scans. Secondary outcome measures are bone quality in the biopsy, buccal bone thickness around the oral implant, number and type of complications, cumulative survival rates of the implants 1 year after loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- split-mouth 2 arm RCT
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Procedure: guided bone regenerationLPRF block as a grafting material |
| Control | Experimental | Procedure: guided bone regeneration50% autogenous bone, 50% DBBM as a grafting material |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females, with ASA I or II, between 18 and 80 years old
- 2 implant sites requiring vertical bone augmentation prior to implant placement
- Both sites in the same jaw
- Good general health as documented by self-assessment
Key exclusion criteria (12 listed)
- Any systemic medical condition that could interfere with the surgical procedure, planned treatment or healing of the patient
- Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
- Current pregnancy or breast feeding/ lactating at the time of recruitment.
- Radiotherapy or Chemotherapy in head and neck area.
- Intravenous and oral bisphosphonate therapy.
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 |
|---|---|---|
| guided bone regenerationAlso: GBRa non-resorbable membrane was used as a space maintainer, filled with a particulated bone graft. | Procedure or surgery | Control, Test |
Primary outcome
bone volume as measured on CBCT scans
Time frame: CBCT scans at intake, with follow-up until 25 months post-operative
CBCT scans taken and software used for measurement
4 secondary outcomes
Buccal bone thickness around the implants
Time frame: CBCT scans at placement of the implant and 1 year after loading of the implant
Buccal bone thickness around the implants
Time frame: CBCT scans at 1 year after loading of the implant
Cumulative survival rate of the implants
Time frame: 16 months of follow-up
rates and types of complications
Time frame: 25 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 19 Mar 2024.
- Individual participant dataSharing planned: No. all info available on request
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Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided bone regeneration in people with Alveolar Bone Resorption, 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 4 inclusion and 12 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 19 Mar 2024. 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?
bone volume as measured on CBCT scans (time frame: CBCT scans at intake, with follow-up until 25 months post-operative). 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 19 Mar 2024.