Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429540
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-21
Brief Title:
Post Extraction Changes Following Ridge Preservation Using Partially Demineralized Dentin Block Versus Xenograft
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Evaluation of Post Extraction Hard Tissue Alteration Following Ridge Preservation Using Partially Demineralized Dentin Block Versus Xenograft in the Esthetic Zone A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to clinically and radiographically evaluate the dimensional changes of hard tissue after using Partially Demineralized Dentin Block versus Xenograft in the esthetic zone
The main question In patients with unrestorable teeth will the use of partially demineralized Dentin Block be more effective than Xenograft in preserving vertical and horizontal ridge dimensions
After enrollment a thorough preoperative assessment including history taking clinical and radiographic examinations will be conducted
Initial therapy includes periodontal treatment phase 1 therapy followed by random assignment to one of two treatment groups ridge preservation using Partially Demineralized Dentin Block or Xenograft
Both groups will undergo atraumatic extraction
For the test group an autogenous partially demineralized dentin graft will be prepared involving tooth cleaning grinding and partial demineralization with the Tooth Transformer device followed by Leukocyte-Platelet Rich Fibrin L-PRF membrane and liquid fibrinogen preparation The L-PRF membranes will be cut mixed with dentin particles and combined with liquid fibrinogen to form a compact graft The block will be placed inside the socket and covered by an L-PRF membrane and secured with a cross-suture
In the control group Xenograft will be used and the socket filled with deproteinized bovine bone mineral covered with a collagen membrane and secured with a cross-suture
After a healing period of 6 months at the time of implant placement a biopsy will be taken using a trephine bur
The main question In patients with unrestorable teeth will the use of partially demineralized Dentin Block be more effective than Xenograft in preserving vertical and horizontal ridge dimensions
After enrollment a thorough preoperative assessment including history taking clinical and radiographic examinations will be conducted
Initial therapy includes periodontal treatment phase 1 therapy followed by random assignment to one of two treatment groups ridge preservation using Partially Demineralized Dentin Block or Xenograft
Both groups will undergo atraumatic extraction
For the test group an autogenous partially demineralized dentin graft will be prepared involving tooth cleaning grinding and partial demineralization with the Tooth Transformer device followed by Leukocyte-Platelet Rich Fibrin L-PRF membrane and liquid fibrinogen preparation The L-PRF membranes will be cut mixed with dentin particles and combined with liquid fibrinogen to form a compact graft The block will be placed inside the socket and covered by an L-PRF membrane and secured with a cross-suture
In the control group Xenograft will be used and the socket filled with deproteinized bovine bone mineral covered with a collagen membrane and secured with a cross-suture
After a healing period of 6 months at the time of implant placement a biopsy will be taken using a trephine bur
Detailed Description:
Objective of the study The aim of this study is to evaluate post extraction hard tissue changes following ridge preservation using Partially Demineralized Dentin Block versus Xenograft in the esthetic zone
Research Procedure Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department Faculty of Dentistry Cairo University
General operative procedures Patients who fulfill the inclusion criteria will be enrolled The nature of the study will be explained to each patient as well as the importance of compliance with pre- and post-operative instructions and follow-up visits
Preoperative preparation A thorough preoperative assessment of all patients will be carried out including history taking clinical examination and radiographic examination
History Each patient will be interviewed to obtain a comprehensive history
Clinical examination Proper intraoral examination will be done to evaluate the following parameters for the tooth of interest 1 Restorability of the tooth 2 Periodontal condition of the tooth to be extracted and the adjacent teeth
Radiographic examination
1 Periapical radiographs will be done to rule out the presence of any periapical infection and evaluate the presence of caries or periodontal disease in the adjacent teeth
2 In cases that meet the inclusion criteria cone beam computed tomography CBCT will be taken at three time points before the surgery immediately after socket preservation and after 6 months The CBCT before the surgery will be used to assess the type of socket while the baseline CBCT immediately after socket preservation will be used to evaluate the horizontal ridge width at 1 3 and 5 mm below the most coronal aspect of the crest and buccal and palatal ridge height The CBCT taken after 6 months will serve to superimpose the two scans and assess long-term changes
Initial Therapy The initial therapy will consist of periodontal treatment phase I therapy including supragingival scaling subgingival debridement if needed adjustment of faulty restorations and polishing Mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques
Patients will be randomly assigned to one of the treatment groups
Test Group Ridge preservation using Partially Demineralized Dentin Block in the esthetic zone
Control Group Ridge preservation using Xenograft in the esthetic zone
Surgical Procedure
Atraumatic extraction
The patient will rinse with 012 Chlorhexidine Hexitol ADCO Pharma Co Egypt
The operator will administer 4 articaine hydrochloride with 1100000 epinephrine Septodent Co for Pharmaceuticals France
Flapless and atraumatic tooth extraction will be initiated by making an intrasulcular incision using a 15c blade
Next a periotome will be used to sever the periodontal ligament PDL fibers followed by the use of a straight elevator and extraction forceps for the extraction process
In the test group the autogenous partially demineralized dentin graft will be prepared as follows A high-speed fine finishing stone and saline irrigation will be used to clean the tooth and remove any decay restoration or foreign materials The tooth will be rinsed twice in phosphate buffered saline The tooth will be dried using air then ground and partially demineralized with the Tooth Transformer device following the manufacturers protocol Dentin particles will be obtained with dimensions of 400 - 800 μm
Dentin block preparation During the preparation of partially demineralized dentin Leukocyte-Platelet Rich Fibrin L-PRF membranes will also be prepared Vacutainer tubes without anticoagulant red cap glass coating will be used to collect four 10-cc blood samples which will then be immediately centrifuged at 2700 rpm for 12 minutes using the IntraSpin centrifuge IntraLock Florida USA Additionally two extra blood samples will be collected in 9-cc non-coated vacutainer tubes without anticoagulants white cap These samples will be centrifuged at 2700 rpm for 3 minutes The resulting yellow fluid liquid fibrinogen at the top of the white cap tubes will be carefully aspirated using a sterile syringe while avoiding red blood cells
The L-PRF clots obtained after 12 minutes of centrifugation will be placed in the Xpression box IntraSpin Intra-Lock Florida USA for 5 minutes to allow gentle compression by gravity into membranes
To prepare the L-PRF block the L-PRF membranes will be cut into small pieces and mixed with the dentin particles at a ratio of 2 membranes to 05 g of dentin providing a 11 volume ratio The liquid fibrinogen will be added to the homogeneous mixture and while shaping the mixture into the desired form it will be gently stirred for approximately 10 seconds Within a few minutes the fibrinogen will convert into fibrin primarily from the activated blood platelets in the chopped L-PRF membranes This process will effectively trap the biomaterial and the L-PRF pieces forming a sturdy block known as the dentin block which serves as a convenient and compact graft
Alveolar ridge preservation Following a thorough cleaning procedure the sockets will be carefully packed with customized dentin blocks that are shaped to match the individual size and contours of each socket Once the grafts are properly adapted to the sockets they will be covered with two layers of L-PRF membranes which will extend approximately 2 mm along the entire envelope formed between the periosteum and the bony boundaries of the sockets in a 360 fashion To ensure stability and prevent displacement the wounds will be secured using non-resorbable sutures Its important to note that the purpose of the sutures is to maintain the position of the grafts and membranes rather than closing the wounds entirely
In the control group The same extraction and socket debridement procedure will be performed Following that the extraction socket will be thoroughly filled with deproteinized bovine bone mineral and a collagen membrane will be employed to cover the socket The membrane will be shaped to extend 2-3 mm beyond the margins of the extraction socket and positioned just beneath the marginal mucosa To ensure its stability a cross-suture will be performed securing the membrane in place
The sutures will be removed two weeks after the surgery
Biopsy collection After a healing period of 6 months at the time of implant placement a biopsy will be taken from the central area of the grafted site using a 3-mm trephine bur The biopsy will be promptly fixed in 10 neutral buffered formalin followed by dehydration through a series of alcohol baths with increasing concentrations ranging from 50 to 100 Subsequently the specimen will be embedded in paraffin Finally a tissue section with a thickness of 4 μm will be prepared and subjected to hematoxylin-eosin staining for subsequent histological analysis
Outcomes Radiographic vertical buccal bone changes vertical palatal bone changes horizontal bone changes percentage of new vital bone formation percentage of residual bone graft and implant primary stability
Research Procedure Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department Faculty of Dentistry Cairo University
General operative procedures Patients who fulfill the inclusion criteria will be enrolled The nature of the study will be explained to each patient as well as the importance of compliance with pre- and post-operative instructions and follow-up visits
Preoperative preparation A thorough preoperative assessment of all patients will be carried out including history taking clinical examination and radiographic examination
History Each patient will be interviewed to obtain a comprehensive history
Clinical examination Proper intraoral examination will be done to evaluate the following parameters for the tooth of interest 1 Restorability of the tooth 2 Periodontal condition of the tooth to be extracted and the adjacent teeth
Radiographic examination
1 Periapical radiographs will be done to rule out the presence of any periapical infection and evaluate the presence of caries or periodontal disease in the adjacent teeth
2 In cases that meet the inclusion criteria cone beam computed tomography CBCT will be taken at three time points before the surgery immediately after socket preservation and after 6 months The CBCT before the surgery will be used to assess the type of socket while the baseline CBCT immediately after socket preservation will be used to evaluate the horizontal ridge width at 1 3 and 5 mm below the most coronal aspect of the crest and buccal and palatal ridge height The CBCT taken after 6 months will serve to superimpose the two scans and assess long-term changes
Initial Therapy The initial therapy will consist of periodontal treatment phase I therapy including supragingival scaling subgingival debridement if needed adjustment of faulty restorations and polishing Mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques
Patients will be randomly assigned to one of the treatment groups
Test Group Ridge preservation using Partially Demineralized Dentin Block in the esthetic zone
Control Group Ridge preservation using Xenograft in the esthetic zone
Surgical Procedure
Atraumatic extraction
The patient will rinse with 012 Chlorhexidine Hexitol ADCO Pharma Co Egypt
The operator will administer 4 articaine hydrochloride with 1100000 epinephrine Septodent Co for Pharmaceuticals France
Flapless and atraumatic tooth extraction will be initiated by making an intrasulcular incision using a 15c blade
Next a periotome will be used to sever the periodontal ligament PDL fibers followed by the use of a straight elevator and extraction forceps for the extraction process
In the test group the autogenous partially demineralized dentin graft will be prepared as follows A high-speed fine finishing stone and saline irrigation will be used to clean the tooth and remove any decay restoration or foreign materials The tooth will be rinsed twice in phosphate buffered saline The tooth will be dried using air then ground and partially demineralized with the Tooth Transformer device following the manufacturers protocol Dentin particles will be obtained with dimensions of 400 - 800 μm
Dentin block preparation During the preparation of partially demineralized dentin Leukocyte-Platelet Rich Fibrin L-PRF membranes will also be prepared Vacutainer tubes without anticoagulant red cap glass coating will be used to collect four 10-cc blood samples which will then be immediately centrifuged at 2700 rpm for 12 minutes using the IntraSpin centrifuge IntraLock Florida USA Additionally two extra blood samples will be collected in 9-cc non-coated vacutainer tubes without anticoagulants white cap These samples will be centrifuged at 2700 rpm for 3 minutes The resulting yellow fluid liquid fibrinogen at the top of the white cap tubes will be carefully aspirated using a sterile syringe while avoiding red blood cells
The L-PRF clots obtained after 12 minutes of centrifugation will be placed in the Xpression box IntraSpin Intra-Lock Florida USA for 5 minutes to allow gentle compression by gravity into membranes
To prepare the L-PRF block the L-PRF membranes will be cut into small pieces and mixed with the dentin particles at a ratio of 2 membranes to 05 g of dentin providing a 11 volume ratio The liquid fibrinogen will be added to the homogeneous mixture and while shaping the mixture into the desired form it will be gently stirred for approximately 10 seconds Within a few minutes the fibrinogen will convert into fibrin primarily from the activated blood platelets in the chopped L-PRF membranes This process will effectively trap the biomaterial and the L-PRF pieces forming a sturdy block known as the dentin block which serves as a convenient and compact graft
Alveolar ridge preservation Following a thorough cleaning procedure the sockets will be carefully packed with customized dentin blocks that are shaped to match the individual size and contours of each socket Once the grafts are properly adapted to the sockets they will be covered with two layers of L-PRF membranes which will extend approximately 2 mm along the entire envelope formed between the periosteum and the bony boundaries of the sockets in a 360 fashion To ensure stability and prevent displacement the wounds will be secured using non-resorbable sutures Its important to note that the purpose of the sutures is to maintain the position of the grafts and membranes rather than closing the wounds entirely
In the control group The same extraction and socket debridement procedure will be performed Following that the extraction socket will be thoroughly filled with deproteinized bovine bone mineral and a collagen membrane will be employed to cover the socket The membrane will be shaped to extend 2-3 mm beyond the margins of the extraction socket and positioned just beneath the marginal mucosa To ensure its stability a cross-suture will be performed securing the membrane in place
The sutures will be removed two weeks after the surgery
Biopsy collection After a healing period of 6 months at the time of implant placement a biopsy will be taken from the central area of the grafted site using a 3-mm trephine bur The biopsy will be promptly fixed in 10 neutral buffered formalin followed by dehydration through a series of alcohol baths with increasing concentrations ranging from 50 to 100 Subsequently the specimen will be embedded in paraffin Finally a tissue section with a thickness of 4 μm will be prepared and subjected to hematoxylin-eosin staining for subsequent histological analysis
Outcomes Radiographic vertical buccal bone changes vertical palatal bone changes horizontal bone changes percentage of new vital bone formation percentage of residual bone graft and implant primary stability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None