Bone ResorptionNCT04709523
Guided Bone Regeneration Using Bovine-derived Xenograft in Combination With or Without Injectable Platelet-rich Fibrin
A study testing bovine-derived xenograft with i-PRF and bovine-derived xenograft alone in people with Bone Resorption, run by Ege University.
Trial summary
The aim of the study was to compare the change in augmentation thickness after guided bone regeneration (GBR) using bovine-derived xenograft in combination with or without injectable platelet-rich fibrin (i-PRF). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- bovine-derived xenograft with i-PRF and bovine-derived xenograft alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2017to 23 Nov 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- horizontal deficiency of the alveolar bone in the posterior regions of mandible
- absence of periodontal disease or previously treated
- with blood tests showing platelet counts at least 150.000 mm3
- ability to understand and accept the requirements of the study.
Who cannot join
- any disorders or infection at the implantation site or adjacent tissue
- tooth loss or extraction in the planned implant site within 6 months
- poor oral hygiene
- medical conditions that compromised tissue healing (uncontrolled diabetes, etc.)
- treatments with an interfering medications (bisphosphonates, steroids etc.)
- smoking habit
- pregnancy or nursing
About this study
Official title: Guided Bone Regeneration Using Bovine-derived Xenograft in Combination With or Without Injectable Platelet-rich Fibrin: a Randomized-controlled Clinical Trial
The aim of the study was to compare the change in augmentation thickness after guided bone regeneration (GBR) using bovine-derived xenograft in combination with or without injectable platelet-rich fibrin (i-PRF).
This randomized-controlled clinical trial was conducted on patients with horizontal bone deficiency in the posterior regions of mandible. After implant placement, GBR procedures were randomly performed using i-PRF enriched bovine-derived xenograft (test group) or bovine derived xenograft alone (control group). Cone-beam computed tomography was taken at the implant sites immediately, and 6 months after surgery for assess the change in augmentation thickness as the primary outcome of the study. The secondary outcomes included marginal bone level and implant survival rate.
Read the detailed description
The study was conducted on patients who had partially edentulism with horizontal deficiency of the alveolar bone in the posterior regions of mandible.
All patients were informed about treatment protocol of the study and also, the risks and benefits associated with participation. Each patient provided written informed consent prior to enrollment.
Randomization was performed after the dental implant surgeries and the patients were randomly assigned to one of the study groups:
Test group included 22 patients treated with GBR using i-PRF-enriched bovine-derived xenograft + resorbable membrane Control group included 22 patients treated with GBR using bovine-derived xenograft + resorbable membrane All patients underwent two-stage surgical protocol that performed by the same experienced surgeon. Following implant placement, i-PRF-enriched bovine-derived xenograft for the test group and bovine-derived xenograft alone for the control group was carefully positioned with light compression around the implants. Finally, the resorbable membrane was placed to cover the augmented area.
As the second stage of surgery, healing caps were placed and the implant-supported fixed prosthesis were completed in approximately one to two months.
- Conditions
- Bone Resorption
- Being tested
- bovine-derived xenograft with i-PRF, bovine-derived xenograft alone
- Keywords
- Guided bone regeneration, Bovine-derived xenograft, Injectable platelet-rich fibrin
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bovine-derived xenograft with i-PRFProcedure or surgery
Bovine-derived xenograft was mixed with i-PRF and was placed in the augmentation site.
bovine-derived xenograft aloneProcedure or surgery
Bovine-derived xenograft was placed in the augmentation site.
| Study group | Role | What they receive |
|---|---|---|
| i-PRF enriched bovine-derived xenograft | Experimental | Patients treated with i-PRF-enriched bovine-derived xenograft + resorbable membrane Receives: Procedure: bovine-derived xenograft with i-PRF |
| bovine-derived xenograft | Experimental | Patients treated with bovine-derived xenograft + resorbable membrane Receives: Procedure: bovine-derived xenograft alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Augmentation thickness
the change in augmentation thickness at surgical site.
Measured: at immediately and at 6 months
Secondary outcomes (1)
Marginal bone level
the change in marginal bone level around the implants after prosthetic loading
Measured: at immediately, at 6 months, at 12 months and at 24th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start4 Jan 2017
- Primary completion4 Mar 2018
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Işık, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709523
- Sponsor's protocol ID
- Ege Dentistry School
- Status last verified
- Feb 2021
- First submitted
- 13 Jan 2021
- Last updated
- 23 Feb 2021
- 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 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Bone Regeneration Using Bovine-derived Xenograft in Combination With or Without Injectable Platelet-rich Fibrin: a Randomized-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04709523
- Acronym / sponsor ID
- Ege Dentistry School
- Conditions
- Bone Resorption
- Keywords
- Guided bone regeneration, Bovine-derived xenograft, Injectable platelet-rich fibrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 4 Mar 2018 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 14 Jan 2021 (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 study was to compare the change in augmentation thickness after guided bone regeneration (GBR) using bovine-derived xenograft in combination with or without injectable platelet-rich fibrin (i-PRF).
This randomized-controlled clinical trial was conducted on patients with horizontal bone deficiency in the posterior regions of mandible. After implant placement, GBR procedures were randomly performed using i-PRF enriched bovine-derived xenograft (test group) or bovine derived xenograft alone (control group). Cone-beam computed tomography was taken at the implant sites immediately, and 6 months after surgery for assess the change in augmentation thickness as the primary outcome of the study. The secondary outcomes included marginal bone level and implant survival rate.
Detailed description
The study was conducted on patients who had partially edentulism with horizontal deficiency of the alveolar bone in the posterior regions of mandible.
All patients were informed about treatment protocol of the study and also, the risks and benefits associated with participation. Each patient provided written informed consent prior to enrollment.
Randomization was performed after the dental implant surgeries and the patients were randomly assigned to one of the study groups:
Test group included 22 patients treated with GBR using i-PRF-enriched bovine-derived xenograft + resorbable membrane Control group included 22 patients treated with GBR using bovine-derived xenograft + resorbable membrane All patients underwent two-stage surgical protocol that performed by the same experienced surgeon. Following implant placement, i-PRF-enriched bovine-derived xenograft for the test group and bovine-derived xenograft alone for the control group was carefully positioned with light compression around the implants. Finally, the resorbable membrane was placed to cover the augmented area.
As the second stage of surgery, healing caps were placed and the implant-supported fixed prosthesis were completed in approximately one to two months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-PRF enriched bovine-derived xenograft | Experimental | Procedure: bovine-derived xenograft with i-PRFPatients treated with i-PRF-enriched bovine-derived xenograft + resorbable membrane |
| bovine-derived xenograft | Experimental | Procedure: bovine-derived xenograft alonePatients treated with bovine-derived xenograft + resorbable membrane |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- horizontal deficiency of the alveolar bone in the posterior regions of mandible
- absence of periodontal disease or previously treated
- with blood tests showing platelet counts at least 150.000 mm3
- ability to understand and accept the requirements of the study.
Key exclusion criteria (7 listed)
- any disorders or infection at the implantation site or adjacent tissue
- tooth loss or extraction in the planned implant site within 6 months
- poor oral hygiene
- medical conditions that compromised tissue healing (uncontrolled diabetes, etc.)
- treatments with an interfering medications (bisphosphonates, steroids etc.)
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 |
|---|---|---|
| bovine-derived xenograft with i-PRFBovine-derived xenograft was mixed with i-PRF and was placed in the augmentation site. | Procedure or surgery | i-PRF enriched bovine-derived xenograft |
| bovine-derived xenograft aloneBovine-derived xenograft was placed in the augmentation site. | Procedure or surgery | bovine-derived xenograft |
Primary outcome
Augmentation thickness
Time frame: at immediately and at 6 months
the change in augmentation thickness at surgical site.
1 secondary outcome
Marginal bone level
Time frame: at immediately, at 6 months, at 12 months and at 24th 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 23 Feb 2021.
Related trials for Bone Resorption
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Optimal Meals to Reduce Bone Resorption in Women With Osteopenia
Osteopenia
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
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The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
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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 bovine-derived xenograft with i-PRF and bovine-derived xenograft alone in people with Bone Resorption, run by Ege University.
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 7 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 23 Feb 2021. 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?
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?
Augmentation thickness (time frame: at immediately and at 6 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 23 Feb 2021.