Dental ImplantsALB-PRFE-PRFNCT06643468
Effectiveness of ALB-PRF With Two Types of Bone Grafts With Putty Form Around Immediate Dental Implants.
A study testing participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen membrane., participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane. and participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and collagen membrane. in people with Dental Implants and Immediate Implant Soft Tissue Healing, run by Mansoura University at 1 site in Egypt.
Trial summary
The goals of this clinical trial study is to evaluate the additive effect, of using ALB-PRF membrane combined with two different types of bone grafts with putty form in treatment of peri-implant bony defects around immediate dental implant within the maxillary esthetic zone. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Immediate Implant Soft Tissue Healing, Immediate Implant With Bone Graft
- What is being tested?
- participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen membrane., participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane. and participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and collagen membrane.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Aug 2024to 1 Jun 2025
- 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
- - Patient between 20-40 years old.
- Unrestorable maxillary tooth/ teeth in the aesthetic zone.
- Adequate keratinized soft tissue.
- Favorable pattern of occlusion.
- Good oral hygiene.
- Patient ability to comply with the required recall visits.
- Patients with type II socket.
Who cannot join
- Local or systemic diseases that contraindicate implant placement or surgery.
- Smokers
- Patients with parafunctional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of ALB-PRF With Two Types of Bone Grafts With Putty Form in the Treatment of Peri-Implant Bony Defects Around Immediate Dental Implants in the Maxillary Aesthetic Zone.
The goals of this clinical trial study is to evaluate the additive effect, of using ALB-PRF membrane combined with two different types of bone grafts with putty form in treatment of peri-implant bony defects around immediate dental implant within the maxillary esthetic zone.
Researchers will compare the ALB- PRF membrane extracted from patient blood with synthetic collagen membrane in addition to the putty form bone graft The main questions it aims to answer are:
Read more
Is the ALB-PRF is considered suitable alternative to synthetic collagen membrane in GBR techniques? also, growth factors releasing form ALB-PRF can continue over 21 days.
Participants will:
receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen as membrane. Also, in other hand participant will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and collagen as membrane. and compered with participants receive the same bone and implant technique except for ALB-PRF membrane instead of collagen.
Read the detailed description
- Patient selection Participants will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University. All patients will be informed regarding the study nature of the surgical procedures, time of treatment, benefits, the suspected risk or complications and follow-up schedule visits and requested to sign a written consent. This study will be performed after getting approval by the ethics committee of the Faculty of Dentistry at Mansoura University.(A02090230M)
Inclusion criteria:
- Patient between 20-40 years old.
- Unrestorable maxillary tooth/ teeth in the aesthetic zone.
- Adequate keratinized soft tissue.
- Favorable pattern of occlusion.
- Good oral hygiene.
- Patient ability to comply with the required recall visits.
- Patients with type II socket.
Exclusion Criteria:
- Local or systemic diseases that contraindicate implant placement or surgery.
- Smokers
- Patients with parafunctional habits.
Study design:
Selected participants will receive forty implants that will be placed immediately after extraction of unrestorable maxillary tooth/ teeth in the aesthetic zone. According to the type of the used bone graft and membrane, the participants will be randomly divided into 4 equal groups:
Group I: will include 10 patients, in which participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen as membrane. Group II: will include 10 patients, in which participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and collagen as membrane.
Group III: will include 10 patients, in which participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane. Group IV: will include 10 patients, in which participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and ALB- PRF as membrane.
Procedures:
Pre-surgical phase:
- Pre-operative CBCT will be used to evaluate the mesiodistal width (inter-radicular distance), residual bone beyond the apex, socket width and root angulation.
- Study cast analysis to evaluate teeth inclinations, inter-arch space and occlusion. - Diagnostic waxing up of missing tooth.
- Premedication: Patients will be premedicated by Amoxicillin 2 gm one hour before surgery as a prophylactic antibiotic, in addition patient will instructed to rinse with a 0.2% chlorhexidine mouth wash for 1 minute immediately prior to surgery.
Surgical phase:
- Injection of local anesthetic Articaine hydrochloride 4% with Epinephrine (1:100,000).
- Atraumatic removal of remaining root or tooth then implant will be placed according to the standard protocol.
- Sulcular incision with be made 15c blade Minimally vertical releasing incision.
- Implant placement with copious irrigation.
- Membranes placement: either ALB-PRF or collagen followed by insertion of putty form of bone graft materials according to the study design.
- Customized healing abutment application.
- Suturing of wound edges with 0.5 suture around the customized healing abutment.
Post-surgical instruction:
- Patients will be instructed to use 0.2% chlorhexidine gluconate mouth wash for 1 minute twice a day for 2 weeks.
- Patients will be maintained on amoxicillin 1gm twice a day for six days postoperatively.
- Ibuprofen 400 mg will be prescribed to be taken 2 to 4 times a day during meals as analgesic.
Loading on implant will be done four months after the implant insertion.
Evaluation:
- Clinical Evaluation: all the following clinical parameters will be reassessed at 0,6,12 months.
- Esthetics: Will be evaluated according to pink esthetic score (PES).
- Peri-implant pocket depth: The distance between the base of the pocket and the gingival margin will be measured using a graduated plastic probe.
- Plaque index (PI) : Plaque index will be taken as an indicator for the patient oral hygiene.
- Implant stability evaluation: Using Resonance Frequency Analysis device (Osstell), implant stability will be assessed in both groups at baseline, 6 months , and 12 months postoperative
- Modified bleeding index. Modified bleeding index will be taken as an indicator gingival inflammation.
II) Radiographic Evaluation:
Using cone beam CT (CBCT) scan, the changes in the marginal bone level and the thickness of buccal plate will be measured at baseline, 6 months and 12 months postoperative.
III) Laboratory analysis :
Samples will be collected using sterile paper strip at day of surgery, one, two, four, and eight weeks postoperatively for analysis of the growth factors concentration according to manufacture instruction using multiplex immunoassay.
Statistical analysis:
The data will be collected and statistical analysis will be done
- Being tested
- participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen membrane., participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane., participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and collagen membrane., participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and ALB-PRF membrane.
- Keywords
- ALB-PRF, putty form bone graft, e- PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen membrane.Procedure or surgery
- Injection of local anesthetic Articaine hydrochloride 4% with Epinephrine (1:100,000).
- Atraumatic removal of remaining root or tooth then implant will be placed according to the standard protocol.
- Sulcular incision with be made 15c blade .
- Implant placement with copious irrigation.
- Membranes placement: collagen followed by insertion of nano-crystalline putty hydroxyapatite.
- Customized healing abutment application.
- Suturing of wound edges with 0.5 suture around the customized healing abutment.
participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane.Procedure or surgery
- Injection of local anesthetic Articaine hydrochloride 4% with Epinephrine (1:100,000).
- Atraumatic removal of remaining root or tooth then implant will be placed according to the standard protocol.
- Sulcular incision with be made 15c blade without vertical releasing incision.
- Implant placement with copious irrigation.
- Membranes placement: ALB-PRF followed by insertion of nano-crystalline putty hydroxyapatite..
- Customized healing abutment application.
- Suturing of wound edges with 0.5 suture around the customized healing abutment.
participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and collagen membrane.Procedure or surgery
- Injection of local anesthetic Articaine hydrochloride 4% with Epinephrine (1:100,000).
- Atraumatic removal of remaining root or tooth then implant will be placed according to the standard protocol.
- Sulcular incision with be made 15c blade .
- Implant placement with copious irrigation.
- Membranes placement: collagen followed by insertion of eta-tricalcium phosphate + calcium sulphate bone graft.
- Customized healing abutment application.
- Suturing of wound edges with 0.5 suture around the customized healing abutment.
participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and ALB-PRF membrane.Procedure or surgery
- Injection of local anesthetic Articaine hydrochloride 4% with Epinephrine (1:100,000).
- Atraumatic removal of remaining root or tooth then implant will be placed according to the standard protocol.
- Sulcular incision with be made 15c blade .
- Implant placement with copious irrigation.
- Membranes placement: ALB-PRF followed by insertion of eta-tricalcium phosphate + calcium sulphate bone graft.
- Customized healing abutment application.
- Suturing of wound edges with 0.5 suture around the customized healing
| Study group | Role | What they receive |
|---|---|---|
| beta-tricalcium phosphate + calcium sulphate bone graft and collagen membrane | Active comparator | will include 10 patients, in which participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and collagen as membrane. Receives: Procedure: participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and collagen membrane. |
| beta-tricalcium phosphate + calcium sulphate bone graft and ALB- PRF membrane | Active comparator | will include 10 patients, in which participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and ALB- PRF as membrane. Receives: Procedure: participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and ALB-PRF membrane. |
| nano-crystalline putty hydroxyapatite bone graft and collagen membrane | Active comparator | will include 10 patients, in which participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen as membrane. Receives: Procedure: participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen membrane. |
| nano-crystalline putty hydroxyapatite bone graft and ALB- PRF membrane | Active comparator | will include 10 patients, in which participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane. Receives: Procedure: participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane. |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft tissue healing. in relation to different membrane and putty form bone
Evaluate if the ALB-PRF membrane in combination with the two tested putty form bone graft materials play a role in acceleration of soft tissues healing.
assessment of soft tissue healing which evaluated according to pink esthetic score (PES).
The pink esthetic score evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14
Measured: clinical parameters will be reassessed at plate will be measured at baseline, 6 months and 12 months postoperative.
Hard tissue healing .
Hard tissue healing evaluation; Using cone beam CT (CBCT) scan, the changes in the marginal bone level and the thickness of buccal plate will be measured at baseline, 6 months and 12 months postoperative.
CBCT will be evaluated and assessed by subtraction methods to notice the gained and loosed bone in millimeters.
Measured: baseline, 6 months and 12 months postoperative
Secondary outcomes (4)
Peri-implant pocket depth
The distance between the base of the pocket and the gingival margin will be measured using a graduated plastic probe.
Measured: baseline, 6 months and 12 months postoperative.
Implant stability evaluation
Using Resonance Frequency Analysis device (Osstell®), implant stability will be assessed in both groups
Measured: baseline, 6 months , and 12 months postoperative
Modified bleeding index
Modified bleeding index will be taken as an indicator gingival inflammation.
Measured: baseline, 6 months , and 12 months postoperative
growth factors concentration
Samples will be collected using sterile paper strip at day of surgery, one, two, four, and eight weeks postoperatively for analysis of the growth factors concentration according to manufacture instruction using multiplex immunoassay
Measured: one, two, four, and eight weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start14 Aug 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
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 Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamzah Abdulatef Mansoor, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643468
- Sponsor's protocol ID
- A02090230M
- Acronym
- ALB-PRFE-PRF
- Status last verified
- Oct 2024
- First submitted
- 22 Sep 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after Completing the study ; the data will be available when requested
Publications
Alsabahi H, Mowafey B, Kandil I, Elgohary N, Youssef J. Clinical and radiographic evaluation of autologous albumin-rich platelet-rich fibrin membrane versus synthetic collagen membrane for immediate dental implant placement in the maxillary esthetic zone: a preliminary randomized clinical trial. BMC Oral Health. 2026 Jan 9;26(1):292. doi: 10.1186/s12903-026-07683-2.
PubMed 41514411
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of ALB-PRF With Two Types of Bone Grafts With Putty Form in the Treatment of Peri-Implant Bony Defects Around Immediate Dental Implants in the Maxillary Aesthetic Zone.
- ClinicalTrials.gov ID
- NCT06643468
- Acronym / sponsor ID
- ALB-PRFE-PRF / A02090230M
- Keywords
- ALB-PRF, putty form bone graft, e- PRF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 16 Oct 2024 (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 goals of this clinical trial study is to evaluate the additive effect, of using ALB-PRF membrane combined with two different types of bone grafts with putty form in treatment of peri-implant bony defects around immediate dental implant within the maxillary esthetic zone.
Researchers will compare the ALB- PRF membrane extracted from patient blood with synthetic collagen membrane in addition to the putty form bone graft The main questions it aims to answer are:
Is the ALB-PRF is considered suitable alternative to synthetic collagen membrane in GBR techniques? also, growth factors releasing form ALB-PRF can continue over 21 days.
Participants will:
receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen as membrane. Also, in other hand participant will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and collagen as membrane. and compered with participants receive the same bone and implant technique except for ALB-PRF membrane instead of collagen.
Detailed description
- Patient selection Participants will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University. All patients will be informed regarding the study nature of the surgical procedures, time of treatment, benefits, the suspected risk or complications and follow-up schedule visits and requested to sign a written consent. This study will be performed after getting approval by the ethics committee of the Faculty of Dentistry at Mansoura University.(A02090230M)
Inclusion criteria:
- Patient between 20-40 years old.
- Unrestorable maxillary tooth/ teeth in the aesthetic zone.
- Adequate keratinized soft tissue.
- Favorable pattern of occlusion.
- Good oral hygiene.
- Patient ability to comply with the required recall visits.
- Patients with type II socket.
Exclusion Criteria:
- Local or systemic diseases that contraindicate implant placement or surgery.
- Smokers
- Patients with parafunctional habits.
Study design:
Selected participants will receive forty implants that will be placed immediately after extraction of unrestorable maxillary tooth/ teeth in the aesthetic zone. According to the type of the used bone graft and membrane, the participants will be randomly divided into 4 equal groups:
Group I: will include 10 patients, in which participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen as membrane. Group II: will include 10 patients, in which participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and collagen as membrane.
Group III: will include 10 patients, in which participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane. Group IV: will include 10 patients, in which participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and ALB- PRF as membrane.
Procedures:
Pre-surgical phase:
- Pre-operative CBCT will be used to evaluate the mesiodistal width (inter-radicular distance), residual bone beyond the apex, socket width and root angulation.
- Study cast analysis to evaluate teeth inclinations, inter-arch space and occlusion. - Diagnostic waxing up of missing tooth.
- Premedication: Patients will be premedicated by Amoxicillin 2 gm one hour before surgery as a prophylactic antibiotic, in addition patient will instructed to rinse with a 0.2% chlorhexidine mouth wash for 1 minute immediately prior to surgery.
Surgical phase:
- Injection of local anesthetic Articaine hydrochloride 4% with Epinephrine (1:100,000).
- Atraumatic removal of remaining root or tooth then implant will be placed according to the standard protocol.
- Sulcular incision with be made 15c blade Minimally vertical releasing incision.
- Implant placement with copious irrigation.
- Membranes placement: either ALB-PRF or collagen followed by insertion of putty form of bone graft materials according to the study design.
- Customized healing abutment application.
- Suturing of wound edges with 0.5 suture around the customized healing abutment.
Post-surgical instruction:
- Patients will be instructed to use 0.2% chlorhexidine gluconate mouth wash for 1 minute twice a day for 2 weeks.
- Patients will be maintained on amoxicillin 1gm twice a day for six days postoperatively.
- Ibuprofen 400 mg will be prescribed to be taken 2 to 4 times a day during meals as analgesic.
Loading on implant will be done four months after the implant insertion.
Evaluation:
- Clinical Evaluation: all the following clinical parameters will be reassessed at 0,6,12 months.
- Esthetics: Will be evaluated according to pink esthetic score (PES).
- Peri-implant pocket depth: The distance between the base of the pocket and the gingival margin will be measured using a graduated plastic probe.
- Plaque index (PI) : Plaque index will be taken as an indicator for the patient oral hygiene.
- Implant stability evaluation: Using Resonance Frequency Analysis device (Osstell), implant stability will be assessed in both groups at baseline, 6 months , and 12 months postoperative
- Modified bleeding index. Modified bleeding index will be taken as an indicator gingival inflammation.
II) Radiographic Evaluation:
Using cone beam CT (CBCT) scan, the changes in the marginal bone level and the thickness of buccal plate will be measured at baseline, 6 months and 12 months postoperative.
III) Laboratory analysis :
Samples will be collected using sterile paper strip at day of surgery, one, two, four, and eight weeks postoperatively for analysis of the growth factors concentration according to manufacture instruction using multiplex immunoassay.
Statistical analysis:
The data will be collected and statistical analysis will be done
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| beta-tricalcium phosphate + calcium sulphate bone graft and collagen membrane | Active comparator | Procedure: participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and collagen membrane.will include 10 patients, in which participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and collagen as membrane. |
| beta-tricalcium phosphate + calcium sulphate bone graft and ALB- PRF membrane | Active comparator | Procedure: participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and ALB-PRF membrane.will include 10 patients, in which participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and ALB- PRF as membrane. |
| nano-crystalline putty hydroxyapatite bone graft and collagen membrane | Active comparator | Procedure: participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen membrane.will include 10 patients, in which participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen as membrane. |
| nano-crystalline putty hydroxyapatite bone graft and ALB- PRF membrane | Active comparator | Procedure: participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane.will include 10 patients, in which participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- - Patient between 20-40 years old.
- Unrestorable maxillary tooth/ teeth in the aesthetic zone.
- Adequate keratinized soft tissue.
- Favorable pattern of occlusion.
- Good oral hygiene.
Key exclusion criteria (3 listed)
- Local or systemic diseases that contraindicate implant placement or surgery.
- Smokers
- Patients with parafunctional habits.
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 |
|---|---|---|
| participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen membrane.1. Injection of local anesthetic Articaine hydrochloride 4% with Epinephrine (1:100,000). 2. Atraumatic removal of remaining root or tooth then implant will be placed according to the standard protocol. 3. Sulcular incision with be made 15c blade . 4. Implant placement with copious irrigation. 5. Membranes placement: collagen followed by insertion of nano-crystalline putty hydroxyapatite. 6. Customized healing abutment application. 7. Suturing of wound edges with 0.5 suture around the customized healing abutment. | Procedure or surgery | nano-crystalline putty hydroxyapatite bone graft and collagen membrane |
| participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane.1. Injection of local anesthetic Articaine hydrochloride 4% with Epinephrine (1:100,000). 2. Atraumatic removal of remaining root or tooth then implant will be placed according to the standard protocol. 3. Sulcular incision with be made 15c blade without vertical releasing incision. 4. Implant placement with copious irrigation. 5. Membranes placement: ALB-PRF followed by insertion of nano-crystalline putty hydroxyapatite.. 6. Customized healing abutment application. 7. Suturing of wound edges with 0.5 suture around the customized healing abutment. | Procedure or surgery | nano-crystalline putty hydroxyapatite bone graft and ALB- PRF membrane |
| participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and collagen membrane.1. Injection of local anesthetic Articaine hydrochloride 4% with Epinephrine (1:100,000). 2. Atraumatic removal of remaining root or tooth then implant will be placed according to the standard protocol. 3. Sulcular incision with be made 15c blade . 4. Implant placement with copious irrigation. 5. Membranes placement: collagen followed by insertion of eta-tricalcium phosphate + calcium sulphate bone graft. 6. Customized healing abutment application. 7. Suturing of wound edges with 0.5 suture around the customized healing abutment. | Procedure or surgery | beta-tricalcium phosphate + calcium sulphate bone graft and collagen membrane |
| participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and ALB-PRF membrane.1. Injection of local anesthetic Articaine hydrochloride 4% with Epinephrine (1:100,000). 2. Atraumatic removal of remaining root or tooth then implant will be placed according to the standard protocol. 3. Sulcular incision with be made 15c blade . 4. Implant placement with copious irrigation. 5. Membranes placement: ALB-PRF followed by insertion of eta-tricalcium phosphate + calcium sulphate bone graft. 6. Customized healing abutment application. 7. Suturing of wound edges with 0.5 suture around the customized healing | Procedure or surgery | beta-tricalcium phosphate + calcium sulphate bone graft and ALB- PRF membrane |
Primary outcome
soft tissue healing. in relation to different membrane and putty form bone
Time frame: clinical parameters will be reassessed at plate will be measured at baseline, 6 months and 12 months postoperative.
Evaluate if the ALB-PRF membrane in combination with the two tested putty form bone graft materials play a role in acceleration of soft tissues healing. assessment of soft tissue healing which evaluated according to pink esthetic score (PES). The pink esthetic score evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14
Hard tissue healing .
Time frame: baseline, 6 months and 12 months postoperative
Hard tissue healing evaluation; Using cone beam CT (CBCT) scan, the changes in the marginal bone level and the thickness of buccal plate will be measured at baseline, 6 months and 12 months postoperative. CBCT will be evaluated and assessed by subtraction methods to notice the gained and loosed bone in millimeters.
4 secondary outcomes
Peri-implant pocket depth
Time frame: baseline, 6 months and 12 months postoperative.
Implant stability evaluation
Time frame: baseline, 6 months , and 12 months postoperative
Modified bleeding index
Time frame: baseline, 6 months , and 12 months postoperative
growth factors concentration
Time frame: one, two, four, and eight weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 41514411Alsabahi H, Mowafey B, Kandil I, Elgohary N, Youssef J. Clinical and radiographic evaluation of autologous albumin-rich platelet-rich fibrin membrane versus synthetic collagen membrane for immediate dental implant placement in the maxillary esthetic zone: a preliminary randomized clinical trial. BMC Oral Health. 2026 Jan 9;26(1):292. doi: 10.1186/s12903-026-07683-2.
- Individual participant dataSharing planned: No. after Completing the study ; the data will be available when requested
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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 participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen membrane., participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane. and participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate bone graft and collagen membrane. in people with Dental Implants and Immediate Implant Soft Tissue Healing, run by Mansoura 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 7 inclusion and 3 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 16 Oct 2024. 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?
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?
soft tissue healing. in relation to different membrane and putty form bone (time frame: clinical parameters will be reassessed at plate will be measured at baseline, 6 months and 12 months postoperative.). 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 NCT06643468, 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 16 Oct 2024.