Platelet-rich FibrinNCT06420713
Horizontal Bone Augmentation of Alveolar Ridge
A study testing Horizontal Bone Augmentation of Alveolar Ridge, Groups and Dental Implants in people with Platelet-rich Fibrin and Bone Substitutes, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The objective of this randomized controlled clinical trial was to evaluate the effects of particulate xenogeneic bone grafts associated with autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) for horizontal alveolar ridge augmentation. Read more about this study
- Who is it for?
- Ages 21 to 74 years
- Conditions the study is for
- Platelet-rich Fibrin, Bone Substitutes, Atrophic Maxilla
- What is being tested?
- Horizontal Bone Augmentation of Alveolar Ridge, Groups and Dental Implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2019to 9 May 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 21 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a requirement for the placement of one to four dental implants exclusively in the maxilla;
- insufficient horizontal bone remaining for dental implant placement (maximum width of 4mm);
- sufficient vertical bone height for subsequent placement of dental implant(s).
Who cannot join
- any contraindication for dental implant placement;
- the need for vertical bone augmentation;
- inflammatory or autoimmune disease in the oral cavity;
- use of immunosuppressants, corticosteroids, or bisphosphonates;
- a history of malignancy in the past 5 years;
- smokers;
Show all 11Show fewer
- patients reporting excessive alcohol consumption;
- decompensated systemic condition;
- uncontrolled periodontal disease;
- insulin-dependent diabetic patients;
- patients with blood-related diseases.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry of Ribeirão Preto - USP
Ribeirão Preto, São Paulo, 14040-904
About this study
Official title: Use of Xenogeneic Bone Graft Associated With Autogenous Bone Graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) for Horizontal Bone Augmentation of Alveolar Ridge: A Randomized Controlled Clinical Trial
The objective of this randomized controlled clinical trial was to evaluate the effects of particulate xenogeneic bone grafts associated with autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) for horizontal alveolar ridge augmentation. Twenty-eight patients presenting edentulous regions and requiring horizontal bone augmentation prior to dental implant placement were included in this study and randomly divided into two groups according to the proposed guided bone regeneration (GBR) treatment.
Fourteen surgical sites corresponding to Group A received bone regeneration with particulate autogenous bone tissue associated with deproteinized bovine bone graft (Bio-Oss Small®; Geistlich AG, Wolhusen, Switzerland). In Group B, fourteen surgical sites were regenerated with deproteinized bovine bone graft (Bio-Oss Small®) associated with L-PRF. In both groups, the grafted region was protected by a collagen membrane (Bio-Gide® Compressed; Geistlich AG, Wolhusen, Switzerland) fixed to the buccal and palatal bone plates using titanium pins.
Read more
Cone-beam computed tomography (CBCT) scans were performed preoperatively, immediately after the GBR surgical procedure, after 8 months of GBR healing, and immediately after dental implant placement to measure linear and volumetric changes in the alveolar ridge. At the time of dental implant placement, after an average period of 8 months following the guided bone regeneration procedures, bone biopsies were taken from the grafted area for histological, histomorphometric, and micro-CT analysis.
After a period of 6 months, the dental implants were reopened to receive implant-supported prosthetic rehabilitation. Implant stability was assessed using resonance frequency analysis at the time of implant placement in the grafted area and after an average of 6 months during the reopening surgical stage. Patient pain perception following bone regeneration procedures was assessed using a visual analog scale. All obtained data were statistically analyzed.
- Conditions
- Platelet-rich Fibrin, Bone Substitutes, Atrophic Maxilla, Cone-beam Computed Tomography, Bone Regeneration
- Being tested
- Horizontal Bone Augmentation of Alveolar Ridge, Groups, Dental Implants
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizontal Bone Augmentation of Alveolar RidgeProcedure or surgery
Elevation of the flap in the anterior region of atrophic maxilla to receive particulate autogenous bone mixed with deproteinized bovine bone graft (Group A) or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) mixed with deproteinized bovine bone graft (Group B). In both groups, bone augmentations were covered with a collagen membrane stabilized with pins.
GroupsProcedure or surgery
The patients underwent Guided Bone Regeneration (GBR) procedures for the reconstruction of atrophic edentulous alveolar ridges and were divided into two groups according to the proposed treatment:
Group A - GBR using a mixture of particulate autogenous bone graft and deproteinized bovine bone graft (Bio-Oss® Small; Geistlich AG, Wolhusen, Switzerland).
Group B - GBR using a mixture of deproteinized bovine bone graft (Bio-Oss® Small) and L-PRF + Liquid Fibrinogen.
Dental ImplantsProcedure or surgery
After 8 months of GBR healing, dental implants were placed in the grafted regions using guided surgery techniques.
Cone beam computed tomography (CBCT) scans were performed preoperatively, immediately after the surgical procedure, and after 8 months of follow-up to measure the linear and volumetric changes in the alveolar ridge. At the time of dental implant placement, after an 8-month period following the GBR procedures, bone biopsies were obtained from the grafted area for histological and micro-CT analysis.
The stability of the implants was assessed using resonance frequency analysis in the immediate postoperative period and at 6 months postoperatively.
After the 6-month period following dental implant placement, the patients were cleared for implant-supported prosthetic rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) | Active comparator | Not described Receives: Procedure: Groups |
| Groups | Active comparator | Not described Receives: Procedure: Horizontal Bone Augmentation of Alveolar Ridge |
| Dental Implants | Active comparator | Not described Receives: Procedure: Dental Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Micro-CT and Histometric analyses
After the period of 8 months from Horizontal Bone Augmentation of Alveolar Ridge, during the dental implant placement by guided surgery, bone samples will be collected at the same location of the implants preparation. The collected bone tissue will be prepared and submitted to Micro-CT and histometric analyses.
Measured: 8 months
Secondary outcomes (1)
Dental Implants ISQ measurement
ISQ will be measured at the moment of implant placement and after 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start20 Oct 2019
- Primary completion30 Apr 2024
- Study completion9 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-rich FibrinStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Reis Messora, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420713
- Sponsor's protocol ID
- 13102219.0.0000.5419
- Status last verified
- Jun 2024
- First submitted
- 14 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Xenogeneic Bone Graft Associated With Autogenous Bone Graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) for Horizontal Bone Augmentation of Alveolar Ridge: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06420713
- Acronym / sponsor ID
- 13102219.0.0000.5419
- Conditions
- Platelet-rich Fibrin, Bone Substitutes, Atrophic Maxilla, Cone-beam Computed Tomography, Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 20 May 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.
The objective of this randomized controlled clinical trial was to evaluate the effects of particulate xenogeneic bone grafts associated with autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) for horizontal alveolar ridge augmentation. Twenty-eight patients presenting edentulous regions and requiring horizontal bone augmentation prior to dental implant placement were included in this study and randomly divided into two groups according to the proposed guided bone regeneration (GBR) treatment.
Fourteen surgical sites corresponding to Group A received bone regeneration with particulate autogenous bone tissue associated with deproteinized bovine bone graft (Bio-Oss Small®; Geistlich AG, Wolhusen, Switzerland). In Group B, fourteen surgical sites were regenerated with deproteinized bovine bone graft (Bio-Oss Small®) associated with L-PRF. In both groups, the grafted region was protected by a collagen membrane (Bio-Gide® Compressed; Geistlich AG, Wolhusen, Switzerland) fixed to the buccal and palatal bone plates using titanium pins.
Cone-beam computed tomography (CBCT) scans were performed preoperatively, immediately after the GBR surgical procedure, after 8 months of GBR healing, and immediately after dental implant placement to measure linear and volumetric changes in the alveolar ridge. At the time of dental implant placement, after an average period of 8 months following the guided bone regeneration procedures, bone biopsies were taken from the grafted area for histological, histomorphometric, and micro-CT analysis.
After a period of 6 months, the dental implants were reopened to receive implant-supported prosthetic rehabilitation. Implant stability was assessed using resonance frequency analysis at the time of implant placement in the grafted area and after an average of 6 months during the reopening surgical stage. Patient pain perception following bone regeneration procedures was assessed using a visual analog scale. All obtained data were statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) | Active comparator | Procedure: Groups |
| Groups | Active comparator | Procedure: Horizontal Bone Augmentation of Alveolar Ridge |
| Dental Implants | Active comparator | Procedure: Dental Implants |
Who may qualify
- Ages
- 21 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a requirement for the placement of one to four dental implants exclusively in the maxilla;
- insufficient horizontal bone remaining for dental implant placement (maximum width of 4mm);
- sufficient vertical bone height for subsequent placement of dental implant(s).
Key exclusion criteria (11 listed)
- any contraindication for dental implant placement;
- the need for vertical bone augmentation;
- inflammatory or autoimmune disease in the oral cavity;
- use of immunosuppressants, corticosteroids, or bisphosphonates;
- a history of malignancy in the past 5 years;
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 Augmentation of Alveolar RidgeElevation of the flap in the anterior region of atrophic maxilla to receive particulate autogenous bone mixed with deproteinized bovine bone graft (Group A) or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) mixed with deproteinized bovine bone graft (Group B). In both groups, bone augmentations were covered with a collagen membrane stabilized with pins. | Procedure or surgery | Groups |
| GroupsThe patients underwent Guided Bone Regeneration (GBR) procedures for the reconstruction of atrophic edentulous alveolar ridges and were divided into two groups according to the proposed treatment: Group A - GBR using a mixture of particulate autogenous bone graft and deproteinized bovine bone graft (Bio-Oss® Small; Geistlich AG, Wolhusen, Switzerland). Group B - GBR using a mixture of deproteinized bovine bone graft (Bio-Oss® Small) and L-PRF + Liquid Fibrinogen. | Procedure or surgery | Autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) |
| Dental ImplantsAfter 8 months of GBR healing, dental implants were placed in the grafted regions using guided surgery techniques. Cone beam computed tomography (CBCT) scans were performed preoperatively, immediately after the surgical procedure, and after 8 months of follow-up to measure the linear and volumetric changes in the alveolar ridge. At the time of dental implant placement, after an 8-month period following the GBR procedures, bone biopsies were obtained from the grafted area for histological and micro-CT analysis. The stability of the implants was assessed using resonance frequency analysis in the immediate postoperative period and at 6 months postoperatively. After the 6-month period following dental implant placement, the patients were cleared for implant-supported prosthetic rehabilitation. | Procedure or surgery | Dental Implants |
Primary outcome
Micro-CT and Histometric analyses
Time frame: 8 months
After the period of 8 months from Horizontal Bone Augmentation of Alveolar Ridge, during the dental implant placement by guided surgery, bone samples will be collected at the same location of the implants preparation. The collected bone tissue will be prepared and submitted to Micro-CT and histometric analyses.
1 secondary outcome
Dental Implants ISQ measurement
Time frame: 6 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 11 Jun 2024.
- 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.
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 Horizontal Bone Augmentation of Alveolar Ridge, Groups and Dental Implants in people with Platelet-rich Fibrin and Bone Substitutes, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 11 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 11 Jun 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 Brazil. 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?
Micro-CT and Histometric analyses (time frame: 8 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 11 Jun 2024.