Immediate Implant PlacementNCT06863051
Effect of Albumin Platelet-Rich Fibrin or Leucocyte- Platelet-Rich Fibrin on Immediate Implant
A study testing Immediate Implant Placement and Alb-PRF and Immediate Implant Placement and L-PRF in people with Immediate Implant Placement, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The objective of this study will be to compare between Immediate Implant grafted with xenograft and Alb-PRF gel versus xenograft with L-PRF. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant Placement
- What is being tested?
- Immediate Implant Placement and Alb-PRF and Immediate Implant Placement and L-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2025to 10 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
- Inclusion criteria
- The presence of non-restorable mandibular molar.
- Patient 18-45 years old
- Intact buccal and lingual walls
- Good oral hygiene.
- Prescence of sufficient restorative space.
- Jumping gap more than 2 mm.
- Exclusion criteria
- Proximity of anatomical structures
- Acute localized infection (suppuration at the surgical field)
- Patients on chemotherapy or radiotherapy.
- Patients who have systemic disorders (diseases) {diabetes mellitus, autoimmune disease, …etc},
- Pregnant patients.
- Smoking and Alcohols.
- Presence of periapical pathology affecting the neighboring teeth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mostafa Mohamed Fayed, Demonstrator of Periodontology contact
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University, Faculty of Dentistry
Kafr ash Shaykh, Kafrelsheikh
Enas Ahmed Elgendy, Dean of Faculty of Dentistry, 0201003508797, enas_ahmed@den.kfs.edu
Enas Ahmed Elgendy, Dean of Faculty of Dentistry
About this study
Official title: Clinical and Radiographic Evaluation of Xenograft With Albumin Platelet-Rich Fibrin or Leucocyte- Platelet-Rich Fibrin on Immediate Implant Placement in Mandibular Molar Extraction Sites: Randomized Clinical Trial.
The objective of this study will be to compare between Immediate Implant grafted with xenograft and Alb-PRF gel versus xenograft with L-PRF.
Read the detailed description
The objective of this study will be to compare between xenograft with Alb-PRF gel and xenograft with L-PRF ( L-PRF Block ) in the aspects of :
- Peri-implant vertical defect depth.
- Crestal bone level.
- Bucco-lingual bone width.
- Keratinized tissue width
- Conditions
- Immediate Implant Placement
- Being tested
- Immediate Implant Placement and Alb-PRF, Immediate Implant Placement and L-PRF
- Keywords
- Implant, PRF, Albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Implant Placement and Alb-PRFProcedure or surgery
Immediate Implant Placement in lower molar region, Grafted with Xenograft and Albumin PRF Gel
Immediate Implant Placement and L-PRFProcedure or surgery
Immediate Implant Placement in lower molar region, Grafted with Xenograft and L-PRF
| Study group | Role | What they receive |
|---|---|---|
| Albumin-PRF group | Experimental | Immediate Implant Placement in lower molar region, Grafted with Xenograft and Albumin PRF Gel Receives: Procedure: Immediate Implant Placement and Alb-PRF |
| L-PRF group | Experimental | Immediate Implant Placement in lower molar region, Grafted with Xenograft and L-PRF ( L-PRF Block ) Receives: Procedure: Immediate Implant Placement and L-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical peri-implant bone level
the distance between implant platform to the most coronal bone-implant contact
Measured: Immediate Post-Operative and 6 months after surgery
Keratinized tissue Width
Width of Keratinized tissue before and after surgery
Measured: Immediate Post-Operative and 6 months after surgery
Crestal bone level
distance between implant platform and bone crest
Measured: Immediate Post-Operative and 6 months after surgery
Secondary outcomes (2)
Implant Stability
by Smart peg
Measured: Immediate Post-Operative and 6 months after surgery
Bucco-lingual bone width
it's measured with a line coinciding with implant platform
Measured: Immediate Post-Operative and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start20 Aug 2025 (estimated)
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant PlacementStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Fayed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863051
- Sponsor's protocol ID
- KFSIRB200-531
- Status last verified
- Jul 2025
- First submitted
- 27 Feb 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Xenograft With Albumin Platelet-Rich Fibrin or Leucocyte- Platelet-Rich Fibrin on Immediate Implant Placement in Mandibular Molar Extraction Sites: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06863051
- Acronym / sponsor ID
- KFSIRB200-531
- Conditions
- Immediate Implant Placement
- Keywords
- Implant, PRF, Albumin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 7 Mar 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.
The objective of this study will be to compare between Immediate Implant grafted with xenograft and Alb-PRF gel versus xenograft with L-PRF.
Detailed description
The objective of this study will be to compare between xenograft with Alb-PRF gel and xenograft with L-PRF ( L-PRF Block ) in the aspects of :
- Peri-implant vertical defect depth.
- Crestal bone level.
- Bucco-lingual bone width.
- Keratinized tissue width
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin-PRF group | Experimental | Procedure: Immediate Implant Placement and Alb-PRFImmediate Implant Placement in lower molar region, Grafted with Xenograft and Albumin PRF Gel |
| L-PRF group | Experimental | Procedure: Immediate Implant Placement and L-PRFImmediate Implant Placement in lower molar region, Grafted with Xenograft and L-PRF ( L-PRF Block ) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Immediate Implant Placement and Alb-PRFImmediate Implant Placement in lower molar region, Grafted with Xenograft and Albumin PRF Gel | Procedure or surgery | Albumin-PRF group |
| Immediate Implant Placement and L-PRFImmediate Implant Placement in lower molar region, Grafted with Xenograft and L-PRF | Procedure or surgery | L-PRF group |
Primary outcome
Vertical peri-implant bone level
Time frame: Immediate Post-Operative and 6 months after surgery
the distance between implant platform to the most coronal bone-implant contact
Keratinized tissue Width
Time frame: Immediate Post-Operative and 6 months after surgery
Width of Keratinized tissue before and after surgery
Crestal bone level
Time frame: Immediate Post-Operative and 6 months after surgery
distance between implant platform and bone crest
2 secondary outcomes
Implant Stability
Time frame: Immediate Post-Operative and 6 months after surgery
Bucco-lingual bone width
Time frame: Immediate Post-Operative and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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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.
Mostafa Mohamed Fayed, Demonstrator of Periodontology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Implant Placement and Alb-PRF and Immediate Implant Placement and L-PRF in people with Immediate Implant Placement, run by Kafrelsheikh 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?
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: looking for participants now, as of the sponsor's last update on 1 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Mohamed Fayed, Demonstrator of Periodontology (0201004668099, mostafa.mohamed@den.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical peri-implant bone level (time frame: Immediate Post-Operative and 6 months after surgery). 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 1 Aug 2025.