Liquid-PRFLiquid-PRFNCT05492357
Effects of Recurrent Application of Liquid-PRF on Hard and Soft Tissues
A study testing Liquid platelet-rich fibrin and Advanced Platelet-rich fibrin plus in people with Liquid-PRF and A-PRF Plus, run by Cezar Edward Lahham at 1 site in Palestinian Territories.
Trial summary
Procedure: Tooth is extracted, then A-PRF+ is placed inside the socket. After that the ridge dimensions is asses clinically at the baseline) in addition to clinical assessment of the gingival biotype at the baseline. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liquid-PRF, A-PRF Plus
- What is being tested?
- Liquid platelet-rich fibrin and Advanced Platelet-rich fibrin plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 15 Jun 2022to 18 Oct 2022
- 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
- Men and women over 18 years of age
- Indication of a simple extraction (Non-molar tooth)
- Delivery of signed informed consent
- Need delayed implant placement in the place of extraction
Who cannot join
- Need for multiple extractions
- Presence of severe swelling prior to surgery in the extraction area
- Regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs
- Presence of hematologic disease
- Previous radiation, chemotherapy, or immunosuppressive treatments
- Uncontrolled diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Recurrent Application of Liquid Platelet-rich Fibrin in the Extraction Socket on the Hard and Soft Tissues. A Randomised Controlled Trial
Procedure: Tooth is extracted, then A-PRF+ is placed inside the socket. After that the ridge dimensions is asses clinically at the baseline) in addition to clinical assessment of the gingival biotype at the baseline.
Then patients will be divided into 2 groups:
Group 1: 50% of patients will have recurrent Liquid-PRF injections inside the extraction socket every 2 weeks (A-PRF+, followed by recurrent Liquid-PRF) Group 2: 50% of patients without recurrent (just A-PRF+) After 3 months from extraction: both groups will be assessed clinically (gingival biotype) \& (Ridge dimensions) in order to assess the role of recurrent application of Liquid-PRF on these parameters.
Read the detailed description
In this study, we will select 20 patients who need a simple tooth extraction, then determine the gingival biotype, take a blood sample to prepare A-PRF+ (centrifugation of the patient's blood for 8 min at 1300 rpm using red caps tubes), then do the extraction. After that, A-PRF+ is prepared and inserted into the extraction socket, and sutured using horizontal mattress suturing technique.
After the clinical assessment of the ridge dimensions at the baseline
Then patients will be divided into 2 groups:
Group 1: 10 patients will have recurrent Liquid-PRF injections inside the extraction socket every 2 weeks (A-PRF+, followed by recurrent Liquid-PRF) Liquid-PRF preparation: Centrifugation of the patient's blood for 8 min at 2500 rpm using white caps tubes.
Group 2: 10 patients without recurrent application of Liquid-PRF (just A-PRF+) After 3 months from extraction: both groups will be assessed clinically (gingival biotype) \& (Ridge dimensions) in order to evaluate the effect of recurrent application of Liquid-PRF on these parameters.
Assessment method:
for Hard tissue evaluation (Bone): we assess the dimensions clinically For soft tissue: we will use a periodontal probe to assess the gingival thickness after giving local anesthesia.
---------------------------------------------
Selection Criteria
INCLUSION CRITERIA:
- Men and women over 18 years of age
- Indication of a simple extraction
- Delivery of signed informed consent
EXCLUSION CRITERIA:
- Need for multiple extractions
- Presence of severe swelling prior to surgery in the extraction area
- Regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs
- Presence of hematologic disease
- Previous radiation, chemotherapy, or immunosuppressive treatments
- Uncontrolled diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy
- Conditions
- Liquid-PRF, A-PRF Plus
- Being tested
- Liquid platelet-rich fibrin, Advanced Platelet-rich fibrin plus
- Keywords
- recurrent, Liquid platelet-rich fibrin, Advanced platelet-rich fibrin plus, ridge preservation
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid platelet-rich fibrinOther
Also called Liquid-PRF
Liquid platelet-rich fibrin is prepared from the patient's blood and injected into the extraction socket every two weeks (up to 3 months = Just 4 times of application)
Advanced Platelet-rich fibrin plusOther
A-PRF+ is placed into the extraction socket immediately after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Advanced platelet-rich fibrin plus + Liquid platelet-rich fibrin | Experimental | A-PRF plus + Liquid-PRF are prepared from the patient's blood. Receives: Other: Liquid platelet-rich fibrin; Other: Advanced Platelet-rich fibrin plus |
| Advanced platelet-rich fibrin plus alone | Experimental | A-PRF+ is prepared from the patient's blood. Receives: Other: Advanced Platelet-rich fibrin plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ridge dimensions
assessment of ridge dimensions 3 months after intervention for both groups. At the baseline it was assessed clinically. After 3 months, the flap was released and the ridge width and height were assessed clinically.
Measured: 3 months
Gingival biotype
assessment of gingival biotype 3 months after intervention according to gingival thickness (using periodontal probe: if <1 mm = Thin, while if >1 =Thick).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start15 Jun 2022
- Primary completion15 Aug 2022
- Study completion18 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liquid-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
- Model description
- Human patients: 20 patients who need tooth/ teeth extraction would be selected according to the following criteria: INCLUSION CRITERIA: 1. Men and women over 18 years of age 2. Indication of a simple extraction 3. Delivery of signed informed consent EXCLUSION CRITERIA: 1. Need for multiple extractions 2. Presence of severe swelling prior to surgery in the extraction area 3. Regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs 4. Presence of hematologic disease 5. Previous radiation, chemotherapy, or immunosuppressive treatments 6. Uncontrolled diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cezar Edward Lahham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cezar Edward Lahham, Arab American University (Palestine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492357
- Sponsor's protocol ID
- PHRC/HC/1151/22
- Acronym
- Liquid-PRF
- Status last verified
- Nov 2022
- First submitted
- 1 Aug 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lahham C, Ta'a MA, Lahham E, Michael S, Zarif W. The effect of recurrent application of concentrated platelet-rich fibrin inside the extraction socket on the hard and soft tissues. a randomized controlled trial. BMC Oral Health. 2023 Sep 19;23(1):677. doi: 10.1186/s12903-023-03400-5.
PubMed 37726689
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Recurrent Application of Liquid Platelet-rich Fibrin in the Extraction Socket on the Hard and Soft Tissues. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05492357
- Acronym / sponsor ID
- Liquid-PRF / PHRC/HC/1151/22
- Conditions
- Liquid-PRF, A-PRF Plus
- Keywords
- recurrent, Liquid platelet-rich fibrin, Advanced platelet-rich fibrin plus, ridge preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cezar Edward LahhamUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 8 Aug 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.
Procedure: Tooth is extracted, then A-PRF+ is placed inside the socket. After that the ridge dimensions is asses clinically at the baseline) in addition to clinical assessment of the gingival biotype at the baseline.
Then patients will be divided into 2 groups:
Group 1: 50% of patients will have recurrent Liquid-PRF injections inside the extraction socket every 2 weeks (A-PRF+, followed by recurrent Liquid-PRF) Group 2: 50% of patients without recurrent (just A-PRF+) After 3 months from extraction: both groups will be assessed clinically (gingival biotype) \& (Ridge dimensions) in order to assess the role of recurrent application of Liquid-PRF on these parameters.
Detailed description
In this study, we will select 20 patients who need a simple tooth extraction, then determine the gingival biotype, take a blood sample to prepare A-PRF+ (centrifugation of the patient's blood for 8 min at 1300 rpm using red caps tubes), then do the extraction. After that, A-PRF+ is prepared and inserted into the extraction socket, and sutured using horizontal mattress suturing technique.
After the clinical assessment of the ridge dimensions at the baseline
Then patients will be divided into 2 groups:
Group 1: 10 patients will have recurrent Liquid-PRF injections inside the extraction socket every 2 weeks (A-PRF+, followed by recurrent Liquid-PRF) Liquid-PRF preparation: Centrifugation of the patient's blood for 8 min at 2500 rpm using white caps tubes.
Group 2: 10 patients without recurrent application of Liquid-PRF (just A-PRF+) After 3 months from extraction: both groups will be assessed clinically (gingival biotype) \& (Ridge dimensions) in order to evaluate the effect of recurrent application of Liquid-PRF on these parameters.
Assessment method:
for Hard tissue evaluation (Bone): we assess the dimensions clinically For soft tissue: we will use a periodontal probe to assess the gingival thickness after giving local anesthesia.
---------------------------------------------
Selection Criteria
INCLUSION CRITERIA:
- Men and women over 18 years of age
- Indication of a simple extraction
- Delivery of signed informed consent
EXCLUSION CRITERIA:
- Need for multiple extractions
- Presence of severe swelling prior to surgery in the extraction area
- Regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs
- Presence of hematologic disease
- Previous radiation, chemotherapy, or immunosuppressive treatments
- Uncontrolled diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Human patients: 20 patients who need tooth/ teeth extraction would be selected according to the following criteria: INCLUSION CRITERIA: 1. Men and women over 18 years of age 2. Indication of a simple extraction 3. Delivery of signed informed consent EXCLUSION CRITERIA: 1. Need for multiple extractions 2. Presence of severe swelling prior to surgery in the extraction area 3. Regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs 4. Presence of hematologic disease 5. Previous radiation, chemotherapy, or immunosuppressive treatments 6. Uncontrolled diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy
| Arm | Type | Receives |
|---|---|---|
| Advanced platelet-rich fibrin plus + Liquid platelet-rich fibrin | Experimental | Other: Liquid platelet-rich fibrin, Other: Advanced Platelet-rich fibrin plusA-PRF plus + Liquid-PRF are prepared from the patient's blood. |
| Advanced platelet-rich fibrin plus alone | Experimental | Other: Advanced Platelet-rich fibrin plusA-PRF+ is prepared from the patient's blood. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women over 18 years of age
- Indication of a simple extraction (Non-molar tooth)
- Delivery of signed informed consent
- Need delayed implant placement in the place of extraction
Key exclusion criteria (6 listed)
- Need for multiple extractions
- Presence of severe swelling prior to surgery in the extraction area
- Regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs
- Presence of hematologic disease
- Previous radiation, chemotherapy, or immunosuppressive treatments
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 |
|---|---|---|
| Liquid platelet-rich fibrinAlso: Liquid-PRFLiquid platelet-rich fibrin is prepared from the patient's blood and injected into the extraction socket every two weeks (up to 3 months = Just 4 times of application) | Other | Advanced platelet-rich fibrin plus + Liquid platelet-rich fibrin |
| Advanced Platelet-rich fibrin plusA-PRF+ is placed into the extraction socket immediately after tooth extraction | Other | Advanced platelet-rich fibrin plus + Liquid platelet-rich fibrin, Advanced platelet-rich fibrin plus alone |
Primary outcome
Ridge dimensions
Time frame: 3 months
assessment of ridge dimensions 3 months after intervention for both groups. At the baseline it was assessed clinically. After 3 months, the flap was released and the ridge width and height were assessed clinically.
Gingival biotype
Time frame: 3 months
assessment of gingival biotype 3 months after intervention according to gingival thickness (using periodontal probe: if <1 mm = Thin, while if >1 =Thick).
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 9 Nov 2022.
- Derived from this study: PubMed 37726689Lahham C, Ta'a MA, Lahham E, Michael S, Zarif W. The effect of recurrent application of concentrated platelet-rich fibrin inside the extraction socket on the hard and soft tissues. a randomized controlled trial. BMC Oral Health. 2023 Sep 19;23(1):677. doi: 10.1186/s12903-023-03400-5.
- 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 Liquid platelet-rich fibrin and Advanced Platelet-rich fibrin plus in people with Liquid-PRF and A-PRF Plus, run by Cezar Edward Lahham 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 4 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 9 Nov 2022. 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: 3 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?
On the ClinicalTrials.gov record for NCT05492357, which also lists 1 linked publication.
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 9 Nov 2022.