Tooth ExtractionNCT06936358
Injectable Platelet-rich Fibrin and Advanced Platelet-rich Fibrin With Xenograft on the Socket Preservation of Mandibular Extracted Molars
A study testing A-PRF and I-PRF in people with Tooth Extraction and Socket Preservation, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Different materials and techniques are employed for socket preservation to reduce the alveolar bone resorption in both the horizontal and vertical dimensions as well as the soft tissue collapse after tooth extraction. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tooth Extraction, Socket Preservation
- What is being tested?
- A-PRF and I-PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Aug 2023to 17 Dec 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who need extraction of hopeless mandibular molars
- Teeth with advanced caries not amenable for conservative treatment
- Patients who are willing and fully capable of complying with the study protocol.
Who cannot join
- Systemic diseases that prevent surgery
- Acute or chronic oral infections
- Periodontal diseases
- Heavy smokers or alcoholics
- On anticoagulant drugs.
- Pregnancy
- History of radiotherapy or chemotherapy of the head and neck region
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
About this study
Official title: Comparison of the Effect of Injectable Platelet-rich Fibrin and Advanced Platelet-rich Fibrin With Xenograft on the Socket Preservation of Mandibular Extracted Molars ( a Randomised Controlled Clinical Trial) Comparison of the Effect of Injectable Platelet-rich Fibrin and Advanced Platelet-rich Fibrin With Xenograft on the Socket Preservation of Mandibular Extracted Molars ( a Randomised Controlled Clinical Trial)
Different materials and techniques are employed for socket preservation to reduce the alveolar bone resorption in both the horizontal and vertical dimensions as well as the soft tissue collapse after tooth extraction. Because of the repair abilities of the growth factors and proteins released by platelets, the development and application of platelet-enriched preparations have revolutionised the area of regenerative medicine.The present study will be designed to study the difference between A-PRF and IPRF with the addition of Xenograft in the preservation of bone in mandibular molars.
- Conditions
- Tooth Extraction, Socket Preservation
- Being tested
- Control, A-PRF, I-PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Control group received bone graft alone after extraction
A-PRFOther
30 mL of whole venous blood will be withdrawn from the antecubital vein via scalp vein catheter centrifuged at 1500 rpm for 14 minutes.
I-PRFOther
30 mL of whole venous blood will be withdrawn from the antecubital vein via scalp vein catheter centrifuged at 700 rpm for 3 minutes
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Other: Control |
| A-PRF | Experimental | Not described Receives: Other: A-PRF |
| I-PRF | Experimental | Not described Receives: Other: I-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in healing
A modified Landry, Turnbull, and Howley healing index will be used to assess wound healing (HI). This entails evaluating the following parameters in a comparative manner using a dichotomic score (1/0). Tissue colour or the presence or absence of redness to indicate inflammatory processes; granulation tissue; suppuration; swelling; degree of tissue epithelialisation (partial or complete); and the presence or absence of bleeding and tenderness on palpation
Measured: Baseline and 12 weeks
change in bone density
Bone density will be measured using CBCT examinations
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start22 Aug 2023
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
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 Tooth ExtractionStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936358
- Sponsor's protocol ID
- 0663_04/2023
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Konbar RT, Khalil AEF, Metawie DMN. Comparison of the effect of injectable platelet rich fibrin and advanced platelet rich fibrin with xenograft on the socket preservation of extracted mandibular molars (a randomized controlled clinical trial). BMC Oral Health. 2026 Mar 10;26(1):608. doi: 10.1186/s12903-026-07877-8.
PubMed 41808060
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Injectable Platelet-rich Fibrin and Advanced Platelet-rich Fibrin With Xenograft on the Socket Preservation of Mandibular Extracted Molars ( a Randomised Controlled Clinical Trial) Comparison of the Effect of Injectable Platelet-rich Fibrin and Advanced Platelet-rich Fibrin With Xenograft on the Socket Preservation of Mandibular Extracted Molars ( a Randomised Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06936358
- Acronym / sponsor ID
- 0663_04/2023
- Conditions
- Tooth Extraction, Socket Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 20 Apr 2025 (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.
Different materials and techniques are employed for socket preservation to reduce the alveolar bone resorption in both the horizontal and vertical dimensions as well as the soft tissue collapse after tooth extraction. Because of the repair abilities of the growth factors and proteins released by platelets, the development and application of platelet-enriched preparations have revolutionised the area of regenerative medicine.The present study will be designed to study the difference between A-PRF and IPRF with the addition of Xenograft in the preservation of bone in mandibular molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control |
| A-PRF | Experimental | Other: A-PRF |
| I-PRF | Experimental | Other: I-PRF |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who need extraction of hopeless mandibular molars
- Teeth with advanced caries not amenable for conservative treatment
- Patients who are willing and fully capable of complying with the study protocol.
Key exclusion criteria (7 listed)
- Systemic diseases that prevent surgery
- Acute or chronic oral infections
- Periodontal diseases
- Heavy smokers or alcoholics
- On anticoagulant drugs.
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 |
|---|---|---|
| ControlControl group received bone graft alone after extraction | Other | Control |
| A-PRF30 mL of whole venous blood will be withdrawn from the antecubital vein via scalp vein catheter centrifuged at 1500 rpm for 14 minutes. | Other | A-PRF |
| I-PRF30 mL of whole venous blood will be withdrawn from the antecubital vein via scalp vein catheter centrifuged at 700 rpm for 3 minutes | Other | I-PRF |
Primary outcome
Change in healing
Time frame: Baseline and 12 weeks
A modified Landry, Turnbull, and Howley healing index will be used to assess wound healing (HI). This entails evaluating the following parameters in a comparative manner using a dichotomic score (1/0). Tissue colour or the presence or absence of redness to indicate inflammatory processes; granulation tissue; suppuration; swelling; degree of tissue epithelialisation (partial or complete); and the presence or absence of bleeding and tenderness on palpation
change in bone density
Time frame: Baseline and 12 weeks
Bone density will be measured using CBCT examinations
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 20 Apr 2025.
- Derived from this study: PubMed 41808060Konbar RT, Khalil AEF, Metawie DMN. Comparison of the effect of injectable platelet rich fibrin and advanced platelet rich fibrin with xenograft on the socket preservation of extracted mandibular molars (a randomized controlled clinical trial). BMC Oral Health. 2026 Mar 10;26(1):608. doi: 10.1186/s12903-026-07877-8.
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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 A-PRF and I-PRF in people with Tooth Extraction and Socket Preservation, run by Hams Hamed Abdelrahman 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 3 inclusion and 7 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 20 Apr 2025. 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. 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?
Change in healing (time frame: Baseline and 12 weeks). 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 NCT06936358, 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 20 Apr 2025.