Effectiveness of ALB-PRF With Two Types of Bone Grafts With Putty Form Around Immediate Dental Implants.
ALB-PRFE-PRF
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.
1 other identifier
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 14, 2024
CompletedFirst Submitted
Initial submission to the registry
September 22, 2024
CompletedFirst Posted
Study publicly available on registry
October 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedOctober 16, 2024
October 1, 2024
8 months
September 22, 2024
October 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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.
baseline, 6 months and 12 months postoperative
Secondary Outcomes (4)
Peri-implant pocket depth
baseline, 6 months and 12 months postoperative.
Implant stability evaluation
baseline, 6 months , and 12 months postoperative
Modified bleeding index
baseline, 6 months , and 12 months postoperative
growth factors concentration
one, two, four, and eight weeks postoperatively
Study Arms (4)
beta-tricalcium phosphate + calcium sulphate bone graft and collagen membrane
ACTIVE COMPARATORwill 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 COMPARATORwill 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 COMPARATORwill 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 COMPARATORwill include 10 patients, in which participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane.
Interventions
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.
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.
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.
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
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- Local or systemic diseases that contraindicate implant placement or surgery.
- Smokers
- Patients with parafunctional habits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
faculty of dentistry Mansoura university ,
Al Mansurah, 022, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- B.D.S, M.S, Master Degree of Oral Medicine & Periodontology
Study Record Dates
First Submitted
September 22, 2024
First Posted
October 16, 2024
Study Start
August 14, 2024
Primary Completion
April 1, 2025
Study Completion
June 1, 2025
Last Updated
October 16, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
after Completing the study ; the data will be available when requested