Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643468
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
Effectiveness of ALB-PRF With Two Types of Bone Grafts With Putty Form Around Immediate Dental Implants
Sponsor:
None
Organization:
None
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALB-PRFE-PRF
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
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:
I 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 UniversityA02090230M
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 02 chlorhexidine mouth wash for 1 minute immediately prior to surgery
Surgical phase
1 Injection of local anesthetic Articaine hydrochloride 4 with Epinephrine 1100000
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 Minimally vertical releasing incision
4 Implant placement with copious irrigation
5 Membranes placement either ALB-PRF or collagen followed by insertion of putty form of bone graft materials according to the study design
6 Customized healing abutment application
7 Suturing of wound edges with 05 suture around the customized healing abutment
Post-surgical instruction
Patients will be instructed to use 02 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
I Clinical Evaluation all the following clinical parameters will be reassessed at 0612 months
1 Esthetics
Will be evaluated according to pink esthetic score PES
2 Peri-implant pocket depth
The distance between the base of the pocket and the gingival margin will be measured using a graduated plastic probe
3 Plaque index PI
Plaque index will be taken as an indicator for the patient oral hygiene
4 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
5 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
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 02 chlorhexidine mouth wash for 1 minute immediately prior to surgery
Surgical phase
1 Injection of local anesthetic Articaine hydrochloride 4 with Epinephrine 1100000
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 Minimally vertical releasing incision
4 Implant placement with copious irrigation
5 Membranes placement either ALB-PRF or collagen followed by insertion of putty form of bone graft materials according to the study design
6 Customized healing abutment application
7 Suturing of wound edges with 05 suture around the customized healing abutment
Post-surgical instruction
Patients will be instructed to use 02 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
I Clinical Evaluation all the following clinical parameters will be reassessed at 0612 months
1 Esthetics
Will be evaluated according to pink esthetic score PES
2 Peri-implant pocket depth
The distance between the base of the pocket and the gingival margin will be measured using a graduated plastic probe
3 Plaque index PI
Plaque index will be taken as an indicator for the patient oral hygiene
4 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
5 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None