Alveolar Bone LossNCT04133090
Comparison of Autogenous Bone Graft and Screw Tent-Pole Technique on Atrophic Mandible
A study testing Autogenous block bone graft and i-PRF enriched allograft material+ screw tent pole technique in people with Alveolar Bone Loss, run by Ege University.
Trial summary
The purpose of the present study was to assess the effect of injectable platelet-rich fibrin (i-PRF) enriched with allograft on alveolar bone regeneration when compared with autogenous block bone graft, in the same participants. The study was designed as a split-mouth randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Autogenous block bone graft and i-PRF enriched allograft material+ screw tent pole technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 11 Apr 2016to 6 Jul 2019
- 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
- Patients who refused to use a partially removable prosthesis and requested dental implant treatment,
- Patients had bilateral, moderate or severe posterior atrophic mandible,
- Patients had precluded conditions suitable for short dental implant.
Who cannot join
- Patients who had systemic diseases (osteoporosis, hemophilia, anemia, etc.),
- Patients who required drugs (bisphosphonate or steroid therapy),
- Patients who had a smoking habit,
- Patients who had received radiation therapy within the last two years,
- Patients who were under 18 years old, pregnant or lactating,
- Patients who had a total platelet count lower than 150,000/mm3.
About this study
Official title: Comparison of Treatment Outcomes of Autogenous Block Bone Graft and Screw Tent-Pole Technique in Combination With Injectable Platelet Rich-Fibrin on Posterior Atrophic Mandible: A Split-Mouth Randomized Study
The purpose of the present study was to assess the effect of injectable platelet-rich fibrin (i-PRF) enriched with allograft on alveolar bone regeneration when compared with autogenous block bone graft, in the same participants.
The study was designed as a split-mouth randomized controlled trial. The patients were randomly assigned to one of two surgical groups: the test group with i-PRF enriched particulate allograft using the screw tent-pole technique; and the control group with autogenous block bone harvested from the ramus area. All augmentation sites covered by leukocytes-PRF (L-PRF) membrane. The primary outcome variable of this study was the radiographic and histologic data collected at postoperative 6 months. The secondary outcome variable was nerve alterations and implant survival.
Read the detailed description
Alveolar bone loss which results from tooth extraction, trauma or age-related factors, gives rise to the functional or structural inefficiency of implant-supported prosthetic rehabilitation. Therefore, bone augmentation techniques and graft materials are required to improve esthetic outcomes and long-term prognosis of dental implant treatment. The purpose of the present study is to evaluate the effect of i-PRF enriched with allograft on bone regeneration when compared with autogenous block bone graft. The hypothesis of the study is that i-PRF enriched with allograft will provide similar results to autogenous block bone graft for three dimensional bone reconstruction. This split-mouth randomized study was conducted in the Department of Oral Surgery of the School of Dentistry. The research protocol and informed consent forms for all procedures on patients, were approved by the local ethics committee of the University in accordance with the Helsinki Declarations of 1983.Selection of the participants was determined by clinical and radiological examination according to the inclusion criteria.Before augmentation surgery, the treatment allocation of bilateral posterior atrophic mandibles were randomly assigned to one or other of the two surgical sides: either the test group ( i-PRF + particulate allograft with screw tent-pole technique + L-PRF) or the control group (autogenous block bone graft + L-PRF) by use of the computer-generated method. Blood samples from thirteen participants were collected by a nurse at the beginning of the surgery.The L-PRF preparation was performed as follows; the venous blood samples were collected in 9 ml x 4 glass tubes without anticoagulant and immediately centrifuged at 2700 rpm for 12 min. After the centrifugation of the samples, the red blood cells (RBC) and platelet-poor plasma (PRP) were separated from the 'buffy coat' described as L-PRF. Then the L-PRF was placed on a special press kit to obtain membrane form.
Non-coated, 8 ml plastic tube without anticoagulant was immediately centrifuged at 2700 rpm for 2 min to obtain i-PRF. Following centrifugation, i-PRF was collected the tube by using a disposable syringe and mixed with allograft material. All surgeries were performed under local anesthesia. A mid-crestal incision was made on either side to expose the edentulous alveolar ridge. Furthermore, a posterior releasing incision was made over the external oblique ridge to provide access to the donor site, in control group.
Control site was treated with autogenous block bone graft and the opposite side (test site) was treated with I-PRF enriched allograft material. L-PRF membrane was used to cover augmentation sites.
The primary outcome variables of this study were the radiographic changes of augmented bone at postoperative 6 months as well as the percentage of newly formed bone, graft material and residual bone in the groups.
The secondary outcome variables were the clinical data on implant survival rate and nerve alterations.
- Conditions
- Alveolar Bone Loss
- Being tested
- Autogenous block bone graft, i-PRF enriched allograft material+ screw tent pole technique
- Keywords
- Bone augmentation, Autogenous block bone graft, Leukocytes and platelet-rich fibrin, Injectable platelet rich fibrin, Tent-pole technique
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous block bone graftProcedure or surgery
Vertical and horizontal osteotomies were performed by means of a 6-mm diameter separation disc under copious irrigation with saline.The harvested bone graft was immediately placed in sterile saline solution to prevent dehydration. Sharp edges around the block graft were rounded under saline irrigation using a 4-mm round bur. The screw holes were properly made on both the recipient site and the block graft using a 1.3 mm drill. The graft was firmly fixed with 1.3 mm screws and a compatible driver. The periphery of the graft and the underlying gap between the screws and the recipient site, were covered with a mixture of particulate allograft and sterile saline solution to minimize resorption and to improve the adaption of the graft. All augmentation sites were covered by L-PRF membrane and flap closure was effected with 4/0 silk suture.
i-PRF enriched allograft material+ screw tent pole techniqueProcedure or surgery
The i-PRF preparation was performed as follows: the blood sample collected in an 8 ml, non-coated plastic tube without anticoagulant was immediately centrifuged at a protocol of 2700 rpm for 2 min. After centrifugation, the liquid autologous fibrin material which comprised the 1 mL upper layer of the tube was collected, using a disposable syringe. The screw holes were made on the recipient site using a 1.3 mm drill. 7 mm long screws were fixed 2mm or 4mm higher than on the recipient site to provide the desired augmentation distance and stabilized by a compatible driver. i-PRF was mixed with allograft material in a sterile metal box. Polymerization was done in 3 to 5 minutes, then this material was applied to the underlying gap between the screws and the recipient site.All augmentation sites were covered by L-PRF membrane and flap closure was effected with 4/0 silk suture.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous block bone graft | Active comparator | Surgical site as control group was treated with autogenous block bone graft. Augmentation site was covered with a mixture of particulate allograft and leukocyte and platelet-rich fibrin (L-PRF) membrane. Receives: Procedure: Autogenous block bone graft |
| i-PRF enriched allograft material+screw tent pole technique | Active comparator | Surgical site as test group was treated with injectable platelet rich-fibrin (i-PRF) enriched allograft material. To avoid soft tissue collapse, screws were used. Augmentation site was covered with leukocyte and platelet-rich fibrin (L-PRF) membrane. Receives: Procedure: i-PRF enriched allograft material+ screw tent pole technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of radiological changes
Radiologic analysis was performed to compare the changes in height of alveolar bone between the study groups
Measured: Change of alveolar bone height at 6 months
Histological assessment
Bone core samples were harvested from the implant placement sites for calculate the relative quantification of newly-formed bone within both groups as a percentage
Measured: Postoperatively 6 months
Secondary outcomes (2)
Clinical assessment
Implant survival
Measured: 6 months, 12 months
Clinical assessment
Incidence of nerve damage were analyzed by six different sensory tests carried out three times for each evaluation area on the chin
Measured: 1 month, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start11 Apr 2016
- Primary completion8 Oct 2018
- Study completion6 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- Model description
- Split-mouth study
- Masking
- None (open label)
- Enrolment
- 13 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
- NCT04133090
- Sponsor's protocol ID
- Dentistry
- Status last verified
- Jan 2020
- First submitted
- 16 Oct 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Outcomes of Autogenous Block Bone Graft and Screw Tent-Pole Technique in Combination With Injectable Platelet Rich-Fibrin on Posterior Atrophic Mandible: A Split-Mouth Randomized Study
- ClinicalTrials.gov ID
- NCT04133090
- Acronym / sponsor ID
- Dentistry
- Conditions
- Alveolar Bone Loss
- Keywords
- Bone augmentation, Autogenous block bone graft, Leukocytes and platelet-rich fibrin, Injectable platelet rich fibrin, Tent-pole technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 6 Jul 2019 (actual)
- First posted
- 21 Oct 2019 (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 purpose of the present study was to assess the effect of injectable platelet-rich fibrin (i-PRF) enriched with allograft on alveolar bone regeneration when compared with autogenous block bone graft, in the same participants.
The study was designed as a split-mouth randomized controlled trial. The patients were randomly assigned to one of two surgical groups: the test group with i-PRF enriched particulate allograft using the screw tent-pole technique; and the control group with autogenous block bone harvested from the ramus area. All augmentation sites covered by leukocytes-PRF (L-PRF) membrane. The primary outcome variable of this study was the radiographic and histologic data collected at postoperative 6 months. The secondary outcome variable was nerve alterations and implant survival.
Detailed description
Alveolar bone loss which results from tooth extraction, trauma or age-related factors, gives rise to the functional or structural inefficiency of implant-supported prosthetic rehabilitation. Therefore, bone augmentation techniques and graft materials are required to improve esthetic outcomes and long-term prognosis of dental implant treatment. The purpose of the present study is to evaluate the effect of i-PRF enriched with allograft on bone regeneration when compared with autogenous block bone graft. The hypothesis of the study is that i-PRF enriched with allograft will provide similar results to autogenous block bone graft for three dimensional bone reconstruction. This split-mouth randomized study was conducted in the Department of Oral Surgery of the School of Dentistry. The research protocol and informed consent forms for all procedures on patients, were approved by the local ethics committee of the University in accordance with the Helsinki Declarations of 1983.Selection of the participants was determined by clinical and radiological examination according to the inclusion criteria.Before augmentation surgery, the treatment allocation of bilateral posterior atrophic mandibles were randomly assigned to one or other of the two surgical sides: either the test group ( i-PRF + particulate allograft with screw tent-pole technique + L-PRF) or the control group (autogenous block bone graft + L-PRF) by use of the computer-generated method. Blood samples from thirteen participants were collected by a nurse at the beginning of the surgery.The L-PRF preparation was performed as follows; the venous blood samples were collected in 9 ml x 4 glass tubes without anticoagulant and immediately centrifuged at 2700 rpm for 12 min. After the centrifugation of the samples, the red blood cells (RBC) and platelet-poor plasma (PRP) were separated from the 'buffy coat' described as L-PRF. Then the L-PRF was placed on a special press kit to obtain membrane form.
Non-coated, 8 ml plastic tube without anticoagulant was immediately centrifuged at 2700 rpm for 2 min to obtain i-PRF. Following centrifugation, i-PRF was collected the tube by using a disposable syringe and mixed with allograft material. All surgeries were performed under local anesthesia. A mid-crestal incision was made on either side to expose the edentulous alveolar ridge. Furthermore, a posterior releasing incision was made over the external oblique ridge to provide access to the donor site, in control group.
Control site was treated with autogenous block bone graft and the opposite side (test site) was treated with I-PRF enriched allograft material. L-PRF membrane was used to cover augmentation sites.
The primary outcome variables of this study were the radiographic changes of augmented bone at postoperative 6 months as well as the percentage of newly formed bone, graft material and residual bone in the groups.
The secondary outcome variables were the clinical data on implant survival rate and nerve alterations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split-mouth study
| Arm | Type | Receives |
|---|---|---|
| Autogenous block bone graft | Active comparator | Procedure: Autogenous block bone graftSurgical site as control group was treated with autogenous block bone graft. Augmentation site was covered with a mixture of particulate allograft and leukocyte and platelet-rich fibrin (L-PRF) membrane. |
| i-PRF enriched allograft material+screw tent pole technique | Active comparator | Procedure: i-PRF enriched allograft material+ screw tent pole techniqueSurgical site as test group was treated with injectable platelet rich-fibrin (i-PRF) enriched allograft material. To avoid soft tissue collapse, screws were used. Augmentation site was covered with leukocyte and platelet-rich fibrin (L-PRF) membrane. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who refused to use a partially removable prosthesis and requested dental implant treatment,
- Patients had bilateral, moderate or severe posterior atrophic mandible,
- Patients had precluded conditions suitable for short dental implant.
Key exclusion criteria (6 listed)
- Patients who had systemic diseases (osteoporosis, hemophilia, anemia, etc.),
- Patients who required drugs (bisphosphonate or steroid therapy),
- Patients who had a smoking habit,
- Patients who had received radiation therapy within the last two years,
- Patients who were under 18 years old, pregnant or lactating,
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 |
|---|---|---|
| Autogenous block bone graftVertical and horizontal osteotomies were performed by means of a 6-mm diameter separation disc under copious irrigation with saline.The harvested bone graft was immediately placed in sterile saline solution to prevent dehydration. Sharp edges around the block graft were rounded under saline irrigation using a 4-mm round bur. The screw holes were properly made on both the recipient site and the block graft using a 1.3 mm drill. The graft was firmly fixed with 1.3 mm screws and a compatible driver. The periphery of the graft and the underlying gap between the screws and the recipient site, were covered with a mixture of particulate allograft and sterile saline solution to minimize resorption and to improve the adaption of the graft. All augmentation sites were covered by L-PRF membrane and flap closure was effected with 4/0 silk suture. | Procedure or surgery | Autogenous block bone graft |
| i-PRF enriched allograft material+ screw tent pole techniqueThe i-PRF preparation was performed as follows: the blood sample collected in an 8 ml, non-coated plastic tube without anticoagulant was immediately centrifuged at a protocol of 2700 rpm for 2 min. After centrifugation, the liquid autologous fibrin material which comprised the 1 mL upper layer of the tube was collected, using a disposable syringe. The screw holes were made on the recipient site using a 1.3 mm drill. 7 mm long screws were fixed 2mm or 4mm higher than on the recipient site to provide the desired augmentation distance and stabilized by a compatible driver. i-PRF was mixed with allograft material in a sterile metal box. Polymerization was done in 3 to 5 minutes, then this material was applied to the underlying gap between the screws and the recipient site.All augmentation sites were covered by L-PRF membrane and flap closure was effected with 4/0 silk suture. | Procedure or surgery | i-PRF enriched allograft material+screw tent pole technique |
Primary outcome
Assessment of radiological changes
Time frame: Change of alveolar bone height at 6 months
Radiologic analysis was performed to compare the changes in height of alveolar bone between the study groups
Histological assessment
Time frame: Postoperatively 6 months
Bone core samples were harvested from the implant placement sites for calculate the relative quantification of newly-formed bone within both groups as a percentage
2 secondary outcomes
Clinical assessment
Time frame: 6 months, 12 months
Clinical assessment
Time frame: 1 month, 6 months, 12 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 18 Jan 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous block bone graft and i-PRF enriched allograft material+ screw tent pole technique in people with Alveolar Bone Loss, 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 3 inclusion and 6 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 18 Jan 2020. 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?
Assessment of radiological changes (time frame: Change of alveolar bone height at 6 months). 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 18 Jan 2020.