Esthetic ZoneNCT07304986
Efficacy of i-PRF Usage in Vestibular Socket Therapy
A study testing Immediate implant with VST and Immediate implant with VST and i-prf in people with Esthetic Zone, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aims for evaluation of A novel method for evaluating i-PRF usage in vestibular socket therapy for immediate implant in defective fresh extraction site. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Esthetic Zone
- What is being tested?
- Immediate implant with VST and Immediate implant with VST and i-prf
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Nov 2023to 21 Mar 2026
- 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 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients has one hopeless tooth in the maxillary anterior region with TYPE II according to Elian classification of sockets (10) and sufficient bone apically and palatally.
- The presence of a natural contralateral tooth for the tooth being replaced.
Who cannot join
- Extraction sockets were grade III.
- Acute infection related to hopeless tooth.
- Allergy to any material or medication used in the study.
- Medically compromised patients according to modified Cornell Medical Index.
- Heavy smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Method for Evaluating i-PRF Usage in Vestibular Socket Therapy for Immediate Implant in Defective Fresh Extraction Site
This study aims for evaluation of A novel method for evaluating i-PRF usage in vestibular socket therapy for immediate implant in defective fresh extraction site.
Read the detailed description
The ultimate objective of implant treatment is providing long-lasting, healthy hard and soft tissue architecture while minimizing intraoperative surgical trauma and postoperative complications. Reducing treatment duration and providing a predictable esthetic outcome are fundamental. Immediate implant placement in fresh extraction sockets is an appealing treatment option satisfying many of these requirements. However, a major concern with immediate implant placement is the possible resorption of the facial bone plate as indicated in multiple studies. This, in turn, results in loss of proper soft tissue support, thus compromising the final esthetic outcome of the implant- supported restoration. Furthermore, post extraction bone resorption would be compounded by the presence of a thin or preexisting facial bone defect and/or a thin gingival phenotype. Multiple approaches were suggested to prevent facial bone resorption and optimize the final esthetic outcome after immediate implant placement in sockets with intact facial bone and soft tissue. These approaches include simple ones like applying a graft in the gap between the implant and the facial socket wall and more sophisticated approaches such as the socket shield technique . The presence of bone and/or soft tissue defects after tooth extraction is not an uncommon finding, further complicating immediate implant placement. Several classifications for fresh extraction sockets were proposed to facilitate the selection of optimum treatment for individual cases.
Currently, a serious of studies has shown that iPRF can produce significantly greater concentrations of platelets and leukocytes when compared to the L-PRF and A-PRF.
- Conditions
- Esthetic Zone
- Being tested
- Immediate implant with VST, Immediate implant with VST and i-prf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant with VSTProcedure or surgery
Preoperative procedure: cone beam computed tomography (CBCT) scan will be used for diagnosis and treatment planning. Nonsurgical periodontal treatment including scaling and root planning will be performed as needed. Under local anesthesia sulcular incisions will be made, and then hopeless teeth will be extracted atraumatically using periotomes. Socket lavage and curettage will be done thoroughly, and dental implants will be inserted.
Immediate implant with VST and i-prfProcedure or surgery
Preoperative procedure: cone beam computed tomography (CBCT) scan will be used for diagnosis and treatment planning. Nonsurgical periodontal treatment including scaling and root planning will be performed as needed. Under local anesthesia sulcular incisions will be made, and then hopeless teeth will be extracted atraumatically using periotomes. Socket lavage and curettage will be done thoroughly, and dental implants will be inserted with i-prf.
| Study group | Role | What they receive |
|---|---|---|
| deficient facial plate of bone management VST only | Experimental | Sockets with deficient facial plate of bone and intact soft tissue will receive VST only. Receives: Procedure: Immediate implant with VST |
| deficient facial plate of bone management with VST and iPRF. | Active comparator | Sockets with deficient facial plate of bone and intact soft tissue will receive VST and iPRF. Receives: Procedure: Immediate implant with VST and i-prf |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of pink aesthetic score of the gingiva
Assessment of clinical and aesthetic parameters after the newly proposed immediate implant placement technique. using pik aesthetic score of gingiva, The Pink Esthetic Score (PES) is a dental assessment tool scoring gingival aesthetics around implants, evaluating mesial/distal papillae, tissue level/contour/color/texture, and alveolar deficiency.
Scoring System 0 (Poor): Marked deficiency or abnormality.
- (Fair): Slight change or minor discrepancy.
- (Excellent): Healthy, normal, ideal appearance.
Measured: 6 and 9 months.
Secondary outcomes (1)
Facial bone thickness
Assessment of radiographic parameters after the newly proposed immediate implant placement technique.will be assessed from implant surface to outer surface of bone will be recorded using cone beam CT, at base line, 6 and 9 months. and will be recorded in millimeters.
Measured: base line, 6 and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start21 Nov 2023
- Primary completion21 Jan 2026 (estimated)
- Study completion21 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esthetic ZoneStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Mohmmed Elshamy, Al-Azhar University
- Investigators
- abdullah el-shamy, MSC, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304986
- Sponsor's protocol ID
- 921/1704
- Status last verified
- Dec 2025
- First submitted
- 31 Jul 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Method for Evaluating i-PRF Usage in Vestibular Socket Therapy for Immediate Implant in Defective Fresh Extraction Site
- ClinicalTrials.gov ID
- NCT07304986
- Acronym / sponsor ID
- 921/1704
- Conditions
- Esthetic Zone
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 21 Jan 2026 (estimated)
- Study completion
- 21 Mar 2026 (estimated)
- First posted
- 26 Dec 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.
This study aims for evaluation of A novel method for evaluating i-PRF usage in vestibular socket therapy for immediate implant in defective fresh extraction site.
Detailed description
The ultimate objective of implant treatment is providing long-lasting, healthy hard and soft tissue architecture while minimizing intraoperative surgical trauma and postoperative complications. Reducing treatment duration and providing a predictable esthetic outcome are fundamental. Immediate implant placement in fresh extraction sockets is an appealing treatment option satisfying many of these requirements. However, a major concern with immediate implant placement is the possible resorption of the facial bone plate as indicated in multiple studies. This, in turn, results in loss of proper soft tissue support, thus compromising the final esthetic outcome of the implant- supported restoration. Furthermore, post extraction bone resorption would be compounded by the presence of a thin or preexisting facial bone defect and/or a thin gingival phenotype. Multiple approaches were suggested to prevent facial bone resorption and optimize the final esthetic outcome after immediate implant placement in sockets with intact facial bone and soft tissue. These approaches include simple ones like applying a graft in the gap between the implant and the facial socket wall and more sophisticated approaches such as the socket shield technique . The presence of bone and/or soft tissue defects after tooth extraction is not an uncommon finding, further complicating immediate implant placement. Several classifications for fresh extraction sockets were proposed to facilitate the selection of optimum treatment for individual cases.
Currently, a serious of studies has shown that iPRF can produce significantly greater concentrations of platelets and leukocytes when compared to the L-PRF and A-PRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deficient facial plate of bone management VST only | Experimental | Procedure: Immediate implant with VSTSockets with deficient facial plate of bone and intact soft tissue will receive VST only. |
| deficient facial plate of bone management with VST and iPRF. | Active comparator | Procedure: Immediate implant with VST and i-prfSockets with deficient facial plate of bone and intact soft tissue will receive VST and iPRF. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients has one hopeless tooth in the maxillary anterior region with TYPE II according to Elian classification of sockets (10) and sufficient bone apically and palatally.
- The presence of a natural contralateral tooth for the tooth being replaced.
Key exclusion criteria (5 listed)
- Extraction sockets were grade III.
- Acute infection related to hopeless tooth.
- Allergy to any material or medication used in the study.
- Medically compromised patients according to modified Cornell Medical Index.
- Heavy smokers.
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 with VSTPreoperative procedure: cone beam computed tomography (CBCT) scan will be used for diagnosis and treatment planning. Nonsurgical periodontal treatment including scaling and root planning will be performed as needed. Under local anesthesia sulcular incisions will be made, and then hopeless teeth will be extracted atraumatically using periotomes. Socket lavage and curettage will be done thoroughly, and dental implants will be inserted. | Procedure or surgery | deficient facial plate of bone management VST only |
| Immediate implant with VST and i-prfPreoperative procedure: cone beam computed tomography (CBCT) scan will be used for diagnosis and treatment planning. Nonsurgical periodontal treatment including scaling and root planning will be performed as needed. Under local anesthesia sulcular incisions will be made, and then hopeless teeth will be extracted atraumatically using periotomes. Socket lavage and curettage will be done thoroughly, and dental implants will be inserted with i-prf. | Procedure or surgery | deficient facial plate of bone management with VST and iPRF. |
Primary outcome
assessment of pink aesthetic score of the gingiva
Time frame: 6 and 9 months.
Assessment of clinical and aesthetic parameters after the newly proposed immediate implant placement technique. using pik aesthetic score of gingiva, The Pink Esthetic Score (PES) is a dental assessment tool scoring gingival aesthetics around implants, evaluating mesial/distal papillae, tissue level/contour/color/texture, and alveolar deficiency. Scoring System 0 (Poor): Marked deficiency or abnormality. 1. (Fair): Slight change or minor discrepancy. 2. (Excellent): Healthy, normal, ideal appearance.
1 secondary outcome
Facial bone thickness
Time frame: base line, 6 and 9 months.
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 26 Dec 2025.
Related trials for Esthetic Zone
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Association Between Peri-implant Soft Tissue Thickness and Midfacial Marginal Mucosal Recession
Midfacial Mucosal Recession
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Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
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Hyaluronic Acid Combined With Xenograft Versus Xenograft Alone in Immediate Implant Placement
Immediate Implant Placement in the Esthetic Zone, NON-RESTORABLE TOOTH IN ESTHETIC ZONE
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Evaluation of Bone Regeneration Outcomes Following Guided Bone Regeneration in the Anterior Maxillary Region
Implant Placement in Maxillary Esthetic Zone
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Guided Root Slice Replantation vs. Socket Shielding for Immediate Implant Placement in Esthetic Zone
TEETH EXTRACTION, Esthetic Zone Implantology
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.
abdullah el-shamy, MSC principal investigator
Al-Azhar University
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 with VST and Immediate implant with VST and i-prf in people with Esthetic Zone, run by Al-Azhar 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 2 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: under way, not looking for participants, as of the sponsor's last update on 26 Dec 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?
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?
assessment of pink aesthetic score of the gingiva (time frame: 6 and 9 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 26 Dec 2025.