Bone RegenerationPhase 4NCT04131894
Effects of Autogenous Dentin Graft on Socket Preservation
A Phase 4 study testing autogenous dentin graft and platelet rich fibrin (PRF) in people with Bone Regeneration and Bone And Bones, run by Bahçeşehir University.
Trial summary
Various graft materials are used to reconstruct bone defects in the jaws due to tooth loss, trauma, advanced periodontal diseases, pathological lesions and congenital disorders. The main features of an ideal bone graft are osteogenesis, osteoinduction and osteoconduction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Regeneration, Bone And Bones, Bone Substitutes
- What is being tested?
- autogenous dentin graft and platelet rich fibrin (PRF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2016to 27 Aug 2018
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age≥18 years,
- Systemically healthy patients (ASA I and II),
- Adequate restorative space for implant-retained restoration.
Who cannot join
- Teeth with deep decay or root canal filling,
- Systemically complicated patients (ASA III, IV, V),
- Presence of acute infection,
- Pregnancy or lactation,
- Unwillingness to return for the follow-up periods
About this study
Official title: Healing of Extraction Sockets Preserved With Autogenous Dentin Graft: A Clinical, Histological, Histomorphometrical and Electron Microscobic Study
Various graft materials are used to reconstruct bone defects in the jaws due to tooth loss, trauma, advanced periodontal diseases, pathological lesions and congenital disorders. The main features of an ideal bone graft are osteogenesis, osteoinduction and osteoconduction. Autogenous bone graft is considered as the gold standard among all bone graft materials. Because it has all the features that an ideal bone graft should have. However, there are some disadvantages such as donor site morbidity, obtaining limited amounts and high rates of resorption. Because of these disadvantages, other bone graft materials such as allografts, xenografts and alloplastic bone grafts are frequently used for bone augmentation. In the light of recent studies, the limits of conventional bone graft materials such as limited osteoconduction capacity and disease transmission have been clearly demonstrated. Due to the disadvantages of these materials, studies are directed to develop alternative graft materials. Aim of this study is to analyse the effects of autogenous dentin graft and mixture of autogenous dentin graft and platelet rich fibrin (PRF) applied to the tooth extraction sockets on bone healing process. A total of 57 extraction sockets in 9 patients who were planned to be treated with dental implant after tooth extraction were evaluated in this study. Extraction sockets were divided randomly into 3 groups. In the first group, sockets were filled with autogenous dentin graft (Group D-20 sockets). In the second group, sockets were filled with the mixture of PRF and autogenous dentin graft (Group DP-21 sockets). In the third group, sockets were left empty as control group (Group C-16 sockets). After 3 months, histological and immunohistochemical evaluations were performed on the samples taken during the implant surgery. Additionally, samples obtained from each group were examined by scanning electron microscopy (SEM).
- Conditions
- Bone Regeneration, Bone And Bones, Bone Substitutes
- Being tested
- autogenous dentin graft, platelet rich fibrin (PRF)
- Keywords
- augmentation, dentin graft, socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autogenous dentin graftBiological
platelet rich fibrin (PRF)Biological
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Extraction sockets with spontaneous healing (16 sockets). |
| Dentin | Active comparator | Extraction sockets were filled with undemineralized autogenous dentin graft (20 sockets). Receives: Biological: autogenous dentin graft |
| Dentin+PRF | Active comparator | Extraction sockets were filled with mixture of undemineralized autogenous dentin graft and platelet rich fibrin (PRF) (21 sockets). Receives: Biological: autogenous dentin graft; Biological: platelet rich fibrin (PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathological Evaluation
Samples obtained from the groups were fixed in 10% formalin solution and decalcified in 5% formic acid solution. The samples were gradually dehydrated in an ethanol series, placed in xylene for clearing, and then embedded in paraffin. The tissue blocks were sectioned at 5µm on a rotary microtome (Leica RM 2125RT, Nussloch, Germany). Sections were stored overnight at 60°C for deparaffinization. Then the deparaffinization process was completed with xylene series. Following this procedure, the sections were passed from the alcohol series and dehydrated. Following deparaffinization, all sections were stained using Hematoxylin-Eosin staining method. Five sections were taken from each sample and used for histopathological evaluation. Images were taken from all sections in X4, X10 and X20 magnification using light microscope (Olympus BX43, Center Valley, PA) with camera attachment. New bone, connective tissue, graft and blood vessel volumes were evaluated by histopathological scoring method.
Measured: 3 months after the augmentation procedure
Immunohistochemical Evaluation
Sections (5 µm) were taken from each sample and deparafinization was completed. Mouse and Rabbit Specific HRP / AEC (ABC) Detection IHC Kit (Abcam, USA) was used to perform the reactions. After this process, the sections were exposed until color change in order to show the immune reaction in the tissue and counterstained briefly with Mayer's hematoxylin. Anti-BMP-2 and anti-RUNX-2 antibodies (Abcam, USA) were used. Finally, the sections were washed with distilled water and then covered with immune closure medium. Images were taken in X4, X10, X20 magnification using light microscope (Olympus BX43, Center Valley, PA) with camera attachment (Carl Zeiss, Germany).
Measured: 3 months after the augmentation procedure
Scanning Electron Microscopy (SEM) Evaluation
After the drying process, 4 samples from each group were coated with a 10 nm thick gold-palladium layer using the coating device (Balzers-SCd 050, Germany). The samples were analyzed at 10 kV with the SEM device (JSM-7001 F, JEOL, Tokyo, Japan) for the purpose of examining the surface formation. For each group, the image was taken at X2000, X5000 and X10.000 magnification.
Measured: 3 months after the augmentation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start5 Dec 2016
- Primary completion30 Apr 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone RegenerationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Principal investigator, Ezgi Yüceer Çetiner, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131894
- Sponsor's protocol ID
- 71146310 [2015-AC-CE-42]
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing of Extraction Sockets Preserved With Autogenous Dentin Graft: A Clinical, Histological, Histomorphometrical and Electron Microscobic Study
- ClinicalTrials.gov ID
- NCT04131894
- Acronym / sponsor ID
- 71146310 [2015-AC-CE-42]
- Conditions
- Bone Regeneration, Bone And Bones, Bone Substitutes
- Keywords
- augmentation, dentin graft, socket preservation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 18 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.
Various graft materials are used to reconstruct bone defects in the jaws due to tooth loss, trauma, advanced periodontal diseases, pathological lesions and congenital disorders. The main features of an ideal bone graft are osteogenesis, osteoinduction and osteoconduction. Autogenous bone graft is considered as the gold standard among all bone graft materials. Because it has all the features that an ideal bone graft should have. However, there are some disadvantages such as donor site morbidity, obtaining limited amounts and high rates of resorption. Because of these disadvantages, other bone graft materials such as allografts, xenografts and alloplastic bone grafts are frequently used for bone augmentation. In the light of recent studies, the limits of conventional bone graft materials such as limited osteoconduction capacity and disease transmission have been clearly demonstrated. Due to the disadvantages of these materials, studies are directed to develop alternative graft materials. Aim of this study is to analyse the effects of autogenous dentin graft and mixture of autogenous dentin graft and platelet rich fibrin (PRF) applied to the tooth extraction sockets on bone healing process. A total of 57 extraction sockets in 9 patients who were planned to be treated with dental implant after tooth extraction were evaluated in this study. Extraction sockets were divided randomly into 3 groups. In the first group, sockets were filled with autogenous dentin graft (Group D-20 sockets). In the second group, sockets were filled with the mixture of PRF and autogenous dentin graft (Group DP-21 sockets). In the third group, sockets were left empty as control group (Group C-16 sockets). After 3 months, histological and immunohistochemical evaluations were performed on the samples taken during the implant surgery. Additionally, samples obtained from each group were examined by scanning electron microscopy (SEM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Extraction sockets with spontaneous healing (16 sockets). |
| Dentin | Active comparator | Biological: autogenous dentin graftExtraction sockets were filled with undemineralized autogenous dentin graft (20 sockets). |
| Dentin+PRF | Active comparator | Biological: autogenous dentin graft, Biological: platelet rich fibrin (PRF)Extraction sockets were filled with mixture of undemineralized autogenous dentin graft and platelet rich fibrin (PRF) (21 sockets). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥18 years,
- Systemically healthy patients (ASA I and II),
- Adequate restorative space for implant-retained restoration.
Key exclusion criteria (5 listed)
- Teeth with deep decay or root canal filling,
- Systemically complicated patients (ASA III, IV, V),
- Presence of acute infection,
- Pregnancy or lactation,
- Unwillingness to return for the follow-up periods
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 dentin graft | Biological | Dentin, Dentin+PRF |
| platelet rich fibrin (PRF) | Biological | Dentin+PRF |
Primary outcome
Histopathological Evaluation
Time frame: 3 months after the augmentation procedure
Samples obtained from the groups were fixed in 10% formalin solution and decalcified in 5% formic acid solution. The samples were gradually dehydrated in an ethanol series, placed in xylene for clearing, and then embedded in paraffin. The tissue blocks were sectioned at 5µm on a rotary microtome (Leica RM 2125RT, Nussloch, Germany). Sections were stored overnight at 60°C for deparaffinization. Then the deparaffinization process was completed with xylene series. Following this procedure, the sections were passed from the alcohol series and dehydrated. Following deparaffinization, all sections were stained using Hematoxylin-Eosin staining method. Five sections were taken from each sample and used for histopathological evaluation. Images were taken from all sections in X4, X10 and X20 magnification using light microscope (Olympus BX43, Center Valley, PA) with camera attachment. New bone, connective tissue, graft and blood vessel volumes were evaluated by histopathological scoring method.
Immunohistochemical Evaluation
Time frame: 3 months after the augmentation procedure
Sections (5 µm) were taken from each sample and deparafinization was completed. Mouse and Rabbit Specific HRP / AEC (ABC) Detection IHC Kit (Abcam, USA) was used to perform the reactions. After this process, the sections were exposed until color change in order to show the immune reaction in the tissue and counterstained briefly with Mayer's hematoxylin. Anti-BMP-2 and anti-RUNX-2 antibodies (Abcam, USA) were used. Finally, the sections were washed with distilled water and then covered with immune closure medium. Images were taken in X4, X10, X20 magnification using light microscope (Olympus BX43, Center Valley, PA) with camera attachment (Carl Zeiss, Germany).
Scanning Electron Microscopy (SEM) Evaluation
Time frame: 3 months after the augmentation procedure
After the drying process, 4 samples from each group were coated with a 10 nm thick gold-palladium layer using the coating device (Balzers-SCd 050, Germany). The samples were analyzed at 10 kV with the SEM device (JSM-7001 F, JEOL, Tokyo, Japan) for the purpose of examining the surface formation. For each group, the image was taken at X2000, X5000 and X10.000 magnification.
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 Oct 2019.
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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 Phase 4 study testing autogenous dentin graft and platelet rich fibrin (PRF) in people with Bone Regeneration and Bone And Bones, run by Bahçeşehir 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 5 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 Oct 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Histopathological Evaluation (time frame: 3 months after the augmentation procedure). The study lists 3 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 Oct 2019.