Alveolar Bone ResorptionNCT04434703
Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF)
A study testing Platelet rich fibrin (PRF), Advanced platelet rich fibrin (A-PRF) and blood clot in people with Alveolar Bone Resorption, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study is clinically and radiographically evaluate the use of advance platelet rich fibrin (A-PRF) versus platelet rich fibrin (PRF) in preservation of alveolar ridge following tooth extraction Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- Platelet rich fibrin (PRF), Advanced platelet rich fibrin (A-PRF) and blood clot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 1 Sep 2021
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with at least one non restorable tooth in upper inter-bicuspid region.
- Stable periodontal condition with no acute periapical infection.
- Systematically healthy conditions.
- Cooperative patients.
- Intact buccal plate of bone.
Who cannot join
- Smokers.
- Patients seeking immediate or early implants.
- Pregnant females.
- Bone diseases.
- Drugs and diseases that may affect platelet count or function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF) A Randomized Clinical Trail :Comparative Study
the aim of this study is clinically and radiographically evaluate the use of advance platelet rich fibrin (A-PRF) versus platelet rich fibrin (PRF) in preservation of alveolar ridge following tooth extraction
Read the detailed description
systemically healthy patients who have at least one non-restorable tooth in the upper inter-bicuspid region and are not seeking immediate or early implant treatment will be allocated in this study after performing nonsurgical periodontal therapy and preoperative periapical therapy to evaluate and improve the condition of the periodontal tissues.
Anesthesia will be given then flapless atraumatic extraction using periotomes followed by forceps after luxation. For all groups, the socket will be debrided using curette then
- group A, the socket will be filled with A.PRF
- group B the socket will be filled with PRF.
- group C no bio-additive will be added.
- Criss cross horizontal mattress suture will be applied to close the extraction wound.
PRF and A-PRF preparation :
10 ml of blood will be drawn from each patient by vein puncture of the antecubital vein.
- Plateletr ich fibrin (PRF) is 3000 rpm and 10 minutes without addition of anticoagulant
- Advanced platelet rich fibrin (A-PRF) is 1300 rpm and 8 minutes.
- Conditions
- Alveolar Bone Resorption
- Being tested
- Platelet rich fibrin (PRF), Advanced platelet rich fibrin (A-PRF), blood clot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrin (PRF)Procedure or surgery
following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 3000 rpm for 10 minutes then criss horizontal mattress suture will be applied to close the extraction wound
Advanced platelet rich fibrin (A-PRF)Procedure or surgery
following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 1300 rpm for 8 minutes then criss horizontal mattress suture will be applied to close the extraction wound
blood clotProcedure or surgery
following atraumatic extraction of the tooth using periotomes, no bio-addative will be added and criss horizontal mattress suture will be applied to close the extraction wound
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich fibrin (PRF) | Active comparator | Platelet rich fibrin is the secoond generation of platelet concentrates which is an autogenous biomaterial that is prepared from the patient's own blood Receives: Procedure: Platelet rich fibrin (PRF) |
| Advanced platelet rich fibrin (A-PRF) | Experimental | Advanced platelet rich fibrin is the last modification of PRF which is expected to contain a relatively greater number of white blood cellsand growth factors Receives: Procedure: Advanced platelet rich fibrin (A-PRF) |
| blood clot | Placebo comparator | normal healing of the wound without adding any biomaterial Receives: Procedure: blood clot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bucco-lingual dimensions
clinical measurement using bone caliper in mm numerical
Measured: 6 months
Secondary outcomes (4)
change in alveolar bone height
radiographic measurement using CBCT in mm numerical
Measured: 6 months
bone dentistry
radiographic measurement using CBCT
Measured: 6 months
soft tissue healing
clinical measurement using landr et al index (healing index) in numerical
Measured: 6 months
postoperative pain scores
clinical measurement using VAS scale in numerical where No pain (0-4 mm) - mild pain (5-44 mm) -moderate pain (45-74 mm), and severe pain (75- 100 mm).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Nov 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone ResorptionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mahmoud AbdAlhameed AbuBasha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434703
- Sponsor's protocol ID
- 6-3-1
- Status last verified
- Jan 2021
- First submitted
- 13 Jun 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: it will include participant's contacts ( name, age , phone number , address ,medical and dental history , periodontal condition) ,periodontal chart and preoperative radiograph
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF) A Randomized Clinical Trail :Comparative Study
- ClinicalTrials.gov ID
- NCT04434703
- Acronym / sponsor ID
- 6-3-1
- Conditions
- Alveolar Bone Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 17 Jun 2020 (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 this study is clinically and radiographically evaluate the use of advance platelet rich fibrin (A-PRF) versus platelet rich fibrin (PRF) in preservation of alveolar ridge following tooth extraction
Detailed description
systemically healthy patients who have at least one non-restorable tooth in the upper inter-bicuspid region and are not seeking immediate or early implant treatment will be allocated in this study after performing nonsurgical periodontal therapy and preoperative periapical therapy to evaluate and improve the condition of the periodontal tissues.
Anesthesia will be given then flapless atraumatic extraction using periotomes followed by forceps after luxation. For all groups, the socket will be debrided using curette then
- group A, the socket will be filled with A.PRF
- group B the socket will be filled with PRF.
- group C no bio-additive will be added.
- Criss cross horizontal mattress suture will be applied to close the extraction wound.
PRF and A-PRF preparation :
10 ml of blood will be drawn from each patient by vein puncture of the antecubital vein.
- Plateletr ich fibrin (PRF) is 3000 rpm and 10 minutes without addition of anticoagulant
- Advanced platelet rich fibrin (A-PRF) is 1300 rpm and 8 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Platelet rich fibrin (PRF) | Active comparator | Procedure: Platelet rich fibrin (PRF)Platelet rich fibrin is the secoond generation of platelet concentrates which is an autogenous biomaterial that is prepared from the patient's own blood |
| Advanced platelet rich fibrin (A-PRF) | Experimental | Procedure: Advanced platelet rich fibrin (A-PRF)Advanced platelet rich fibrin is the last modification of PRF which is expected to contain a relatively greater number of white blood cellsand growth factors |
| blood clot | Placebo comparator | Procedure: blood clotnormal healing of the wound without adding any biomaterial |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with at least one non restorable tooth in upper inter-bicuspid region.
- Stable periodontal condition with no acute periapical infection.
- Systematically healthy conditions.
- Cooperative patients.
- Intact buccal plate of bone.
Key exclusion criteria (5 listed)
- Smokers.
- Patients seeking immediate or early implants.
- Pregnant females.
- Bone diseases.
- Drugs and diseases that may affect platelet count or function.
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 |
|---|---|---|
| Platelet rich fibrin (PRF)following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 3000 rpm for 10 minutes then criss horizontal mattress suture will be applied to close the extraction wound | Procedure or surgery | Platelet rich fibrin (PRF) |
| Advanced platelet rich fibrin (A-PRF)following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 1300 rpm for 8 minutes then criss horizontal mattress suture will be applied to close the extraction wound | Procedure or surgery | Advanced platelet rich fibrin (A-PRF) |
| blood clotfollowing atraumatic extraction of the tooth using periotomes, no bio-addative will be added and criss horizontal mattress suture will be applied to close the extraction wound | Procedure or surgery | blood clot |
Primary outcome
Change in bucco-lingual dimensions
Time frame: 6 months
clinical measurement using bone caliper in mm numerical
4 secondary outcomes
change in alveolar bone height
Time frame: 6 months
bone dentistry
Time frame: 6 months
soft tissue healing
Time frame: 6 months
postoperative pain scores
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: Undecided. it will include participant's contacts ( name, age , phone number , address ,medical and dental history , periodontal condition) ,periodontal chart and preoperative radiograph
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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 Platelet rich fibrin (PRF), Advanced platelet rich fibrin (A-PRF) and blood clot in people with Alveolar Bone Resorption, run by Cairo University at 1 site in Egypt.
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 5 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: status not confirmed, as of the sponsor's last update on 29 Jan 2021. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change in bucco-lingual dimensions (time frame: 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 29 Jan 2021.