A-PRFNCT05536492
Sticky Bone Compared to A-PRF(Platlet Rich Fibrin) Effect on Alveolar Ridge Preservation
A study testing A-PRF and ALLOGRAFT in people with A-PRF and ALLOGRAFT, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
Trial summary
In this research investigators are going to detect the effect of using different type of materials(sticky bone\platlet rich fibrin ) compared to normal healing on the dimensional changes of alveolar crest after single rooted tooth extraction by using CBCT (cone-beam computed tomography) at time of extraction and after… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- A-PRF and ALLOGRAFT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 7 Sep 2022to 1 Oct 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- presence of the buccal and palatal/lingual bony walls evaluated clinically by measuring the thickness of the alveolar ridge and radiologically by a CBCT , and residual periodontal attachment of at least 6 mm of single rooted tooth
Who cannot join
- complicated tooth extraction, and any medical problem that could interfere with the mucosal and bony healing processes or contraindicating an implant placement, such as anticoagulation, antiaggregatory medication, radiotherapy, bisphosphonate therapy, diabetes, endocarditis risk factors, immunosuppression, and renal or hepatic failure
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
ArabAmericanU
Ramallah, West Bank
About this study
Official title: Autologous Fibrin Glue Mixed With Bone Graft(Sticky Bone) and Advanced Platelet Rich Fibrin Compared to Conventional Alveolar Ridge Preservation Technique : Randomized Controlled Trial
In this research investigators are going to detect the effect of using different type of materials(sticky bone\platlet rich fibrin ) compared to normal healing on the dimensional changes of alveolar crest after single rooted tooth extraction by using CBCT (cone-beam computed tomography) at time of extraction and after 16-24 weeks
Read the detailed description
Patients who are treated and referred for having extractions in the upper and lower arch for single rooted teeth will have CBCT for each patient at time of extraction (T0) and after 3 months (T1) , by using the cross sectional of the CBCT investigators will measure the difference from the middle of the socket to buccal and palatal\lingual walls at 3 different points below the crest 1mm, 3mm , 5mm .
- the thickness of the buccal bone at baseline (T0) at 1, 3 and 5 mm below the crest
- the horizontal ridge width at crest- 1 mm (HW- 1 mm), crest- 3 mm (HW- 3 mm) and crest- 5 mm (HW- 5 mm) at the buccal/palatal side, in millimetres and later transformed to percentages
- the vertical resorption on both buccal and palatal side, in millimetres
- the socket fill defined as the highest point of viewable mineralized bone at the middle of the socket; absolute values (in mm) and percentages were calculated by comparing the initial depth of the socket and the depth after three months of healing preparation of the materials to be augmented : autologous fibrin glue mixed with bone graft(sticky bone) would be prepared by using green tubes by choukroun company centrifuged at 1300 rpm for 14 minutes (using DUE centrifuge) then mixed with 0.5 cc FDBA and the exudate of the compressed A-PRF then applied to the extraction site A-PRF PLUGS will be prepared using red tubes using venous blood centrifuged at 1300 rpm for 14 min , then the compressed using special tray and applied in the extraction sockets
- Being tested
- A-PRF, ALLOGRAFT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-PRFProcedure or surgery
EXTRACTION FOR SINGLE rooted tooth followed by augmentation with PRF
ALLOGRAFTProcedure or surgery
EXTRACTION FOR SINGLE rooted tooth followed by augmentation with PRF + ALLOGRAFT
| Study group | Role | What they receive |
|---|---|---|
| G1-Control group | No intervention | normal socket healing after extraction without intervention |
| G2 | Experimental | SOCKET AUGMENTATION WITH A-PRF ALONE Receives: Procedure: A-PRF |
| G3 | Experimental | SOCKET AUGMENTATION WITH A-PRF + ALLOGRAFT Receives: Procedure: A-PRF; Procedure: ALLOGRAFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
RIDGE DIMENSIONS
USING CBCT
Measured: 4 Months
BONE DENSITY
USING CBCT
Measured: 4 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start7 Sep 2022
- Primary completion30 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for A-PRFStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab American University (Palestine)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Nassar, Arab American University (Palestine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536492
- Sponsor's protocol ID
- PHRC/HC/1087/22
- Status last verified
- Oct 2023
- First submitted
- 5 Sep 2022
- Last updated
- 11 Oct 2023
- 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 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Fibrin Glue Mixed With Bone Graft(Sticky Bone) and Advanced Platelet Rich Fibrin Compared to Conventional Alveolar Ridge Preservation Technique : Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05536492
- Acronym / sponsor ID
- PHRC/HC/1087/22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Arab American University (Palestine)University, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 13 Sep 2022 (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.
In this research investigators are going to detect the effect of using different type of materials(sticky bone\platlet rich fibrin ) compared to normal healing on the dimensional changes of alveolar crest after single rooted tooth extraction by using CBCT (cone-beam computed tomography) at time of extraction and after 16-24 weeks
Detailed description
Patients who are treated and referred for having extractions in the upper and lower arch for single rooted teeth will have CBCT for each patient at time of extraction (T0) and after 3 months (T1) , by using the cross sectional of the CBCT investigators will measure the difference from the middle of the socket to buccal and palatal\lingual walls at 3 different points below the crest 1mm, 3mm , 5mm .
- the thickness of the buccal bone at baseline (T0) at 1, 3 and 5 mm below the crest
- the horizontal ridge width at crest- 1 mm (HW- 1 mm), crest- 3 mm (HW- 3 mm) and crest- 5 mm (HW- 5 mm) at the buccal/palatal side, in millimetres and later transformed to percentages
- the vertical resorption on both buccal and palatal side, in millimetres
- the socket fill defined as the highest point of viewable mineralized bone at the middle of the socket; absolute values (in mm) and percentages were calculated by comparing the initial depth of the socket and the depth after three months of healing preparation of the materials to be augmented : autologous fibrin glue mixed with bone graft(sticky bone) would be prepared by using green tubes by choukroun company centrifuged at 1300 rpm for 14 minutes (using DUE centrifuge) then mixed with 0.5 cc FDBA and the exudate of the compressed A-PRF then applied to the extraction site A-PRF PLUGS will be prepared using red tubes using venous blood centrifuged at 1300 rpm for 14 min , then the compressed using special tray and applied in the extraction sockets
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G1-Control group | No intervention | –normal socket healing after extraction without intervention |
| G2 | Experimental | Procedure: A-PRFSOCKET AUGMENTATION WITH A-PRF ALONE |
| G3 | Experimental | Procedure: A-PRF, Procedure: ALLOGRAFTSOCKET AUGMENTATION WITH A-PRF + ALLOGRAFT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- presence of the buccal and palatal/lingual bony walls evaluated clinically by measuring the thickness of the alveolar ridge and radiologically by a CBCT , and residual periodontal attachment of at least 6 mm of single rooted tooth
Key exclusion criteria (1 listed)
- complicated tooth extraction, and any medical problem that could interfere with the mucosal and bony healing processes or contraindicating an implant placement, such as anticoagulation, antiaggregatory medication, radiotherapy, bisphosphonate therapy, diabetes, endocarditis risk factors, immunosuppression, and renal or hepatic failure
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 |
|---|---|---|
| A-PRFEXTRACTION FOR SINGLE rooted tooth followed by augmentation with PRF | Procedure or surgery | G2, G3 |
| ALLOGRAFTEXTRACTION FOR SINGLE rooted tooth followed by augmentation with PRF + ALLOGRAFT | Procedure or surgery | G3 |
Primary outcome
RIDGE DIMENSIONS
Time frame: 4 Months
USING CBCT
BONE DENSITY
Time frame: 4 MONTHS
USING CBCT
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 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for A-PRF
Not yet recruiting
Microneedling-Assisted i-PRF for Interdental Papilla Deficiency
Interdental Papilla Deficiency
Not yet recruiting
Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw
Osteonecrosis of the Jaw
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Recruiting
Different Approaches for Alveolar Ridge Preservation
Alveolar Ridge Resorption
Recruiting
Treating Intrabony Defect With MINST VS MINST Extended PRF
Periodontal Intrabony Defects
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 A-PRF and ALLOGRAFT in people with A-PRF and ALLOGRAFT, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
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 1 inclusion and 1 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 Oct 2023. 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 Palestinian Territories. 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?
RIDGE DIMENSIONS (time frame: 4 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 11 Oct 2023.