Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569264
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
Evaluation of Dentin Graft and I-PRF With and Without Vitamin C for Post-extraction Socket Preservation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical and Radiographic Evaluation of Dentin Graft and I-PRF With and Without Vitamin C for Post-extraction Socket Preservation 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to clinically and radio graphically evaluate marginal bone loss following autogenous demineralized dentin graft ADDG and i-PRF addition with and without vitamin C AA for post extraction socket preservation
The main question is
In patient with non-restorable teeth does adding vitamin C to dentin graft and i-PRF affect the marginal bone loss of post extraction sockets
Intervention group
Alveolar ridge preservation using vitamin C AA with autogenous demineralized dentin graft combined with i-PRF
Adding vitamin C to dentin graft and i-PRF might aid in reducing the dimensional changes and marginal bone loss since it increases osteoblast proliferation and viability during socket preservation Layers of osteoblast cell morphology can be seen at day 11 with the presence of 25mM of vitamin C By adding vitamin C to i-PRF we can add the advantages of improving soft tissue quality as well
Control group
Alveolar ridge preservation using autogenous demineralized denting graft combined with i-PRF Dentin particle can be used as an excellent autogenous graft material to replace other autogenous graft materials it can be used in socket preservation as it enhances bone formation and has shown an ability to maintain the alveolar ridge dimensions because of its osteo-conductive properties Moreover dentin graft is used as a cost-effective grafting material during socket preservation
The initial therapy consists of periodontal treatment phase I therapy including supragingival scaling subgingival debridement if needed adjustment of faulty restoration and polishing The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques Flapless and atraumatic tooth extraction will be initiated Then the sockets will be carefully packed with the allocated graft material 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 the corresponding graft material and an absorbable gelatin sponge gelfoam will be used for socket and graft material coverage and secured using an internal crisscross knot using 5-0 monofilament polypropylene suture material
The main question is
In patient with non-restorable teeth does adding vitamin C to dentin graft and i-PRF affect the marginal bone loss of post extraction sockets
Intervention group
Alveolar ridge preservation using vitamin C AA with autogenous demineralized dentin graft combined with i-PRF
Adding vitamin C to dentin graft and i-PRF might aid in reducing the dimensional changes and marginal bone loss since it increases osteoblast proliferation and viability during socket preservation Layers of osteoblast cell morphology can be seen at day 11 with the presence of 25mM of vitamin C By adding vitamin C to i-PRF we can add the advantages of improving soft tissue quality as well
Control group
Alveolar ridge preservation using autogenous demineralized denting graft combined with i-PRF Dentin particle can be used as an excellent autogenous graft material to replace other autogenous graft materials it can be used in socket preservation as it enhances bone formation and has shown an ability to maintain the alveolar ridge dimensions because of its osteo-conductive properties Moreover dentin graft is used as a cost-effective grafting material during socket preservation
The initial therapy consists of periodontal treatment phase I therapy including supragingival scaling subgingival debridement if needed adjustment of faulty restoration and polishing The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques Flapless and atraumatic tooth extraction will be initiated Then the sockets will be carefully packed with the allocated graft material 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 the corresponding graft material and an absorbable gelatin sponge gelfoam will be used for socket and graft material coverage and secured using an internal crisscross knot using 5-0 monofilament polypropylene suture material
Detailed Description:
Research objective
Socket preservation is one of the techniques utilized to maintain bone dimension and minimized post-extraction dimensional changes Adding vitamin C to dentin graft and i-PRF might aid in reducing the dimensional changes and marginal bone loss since it increases osteoblast proliferation and viability during socket preservation By adding vitamin C with i-PRF we can add the advantages of improving soft tissue quality as well Layers of osteoblast cell morphology can be seen at day 11 with the presence of 25mM of vitamin C Moreover dentin graft is used as a cost-effective grafting material during socket preservation
l Inclusion criteria
18 years of age
Single extraction of non-molar teeth with periodontally healthy adjacent teeth
Non-contributory medial history
Non- restorable teeth indicated for extraction
Requiring alveolar preservation after tooth extraction prior to placement of dental implant
Participants that are eligible for immediate implantation yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction ex Financial related factors - psychological psychological factors - time related factors
Cooperative patients who are willing to commit for 6 months follow up
II Exclusion criteria
Pregnant female
Acute infection at extraction site
Systemic conditions affecting healing eg diabetes medications as bisphosphonates
A participant who had radiotherapy or chemotherapy
Psychiatric patient or with a learning disability or unable to give consent
Research Procedure in brief
The study is to be conducted in the Oral Medicine and Periodontology department Faculty of Dentistry- Cairo University EgyptPatients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology clinic of the department of Oral surgery and clinic of the department of Endodontics -Cairo University The initial therapy consists of periodontal treatment phase I therapy including supragingival scaling subgingival debridement if needed adjustment of faulty restoration and polishing The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques Rinsing with 012 chlorhexidine will be instructed
In both groups tooth extraction under local anesthesia with articaine HCL 2 120000 epinephrine will be performed Flapless minimally traumatic extraction will be done using thin periotomes and luxators After thorough mechanical cleaning the sockets will be rinsed with 5 ml of an aqueous 0125 chlorhexidine digluconate solution followed by a 5 ml sterile saline rinse to remove tissue debris from the socket This procedure will be repeated three times for each socket Followed by inspection of extraction socket integrity using a Williams graduated periodontal probe Then extracted teeth will be cleaned from periodontal ligaments cementum soft tissue attachment caries or restorations if present using a high-speed fine finishing stone and saline irrigation The pulp chamber will be cleaned with sterile endodontic files Subsequently teeth will be ground using hand bone mill
The demineralized autogenous tooth graft ADDG particles prepared by demineralization of tooth particles in 06N hydrochloric acid for 30 min to achieve demineralized then washed twice in saline and dried with sterile gauze
For i-PRF preparation blood will be withdrawn in plastic tubes without anticoagulant
In the intervention group 25mM of pure vitamin C will be added to the fresh blood and the tube will be centrifuged at around 700 RPM for 3 minutes
The extraction socket will be filled with the corresponding graft material and an absorbable gelatin sponge gelfoam will be used for socket and graft material coverage and secured using an internal crisscross knot using 5-0 monofilament polypropylene suture material
Postoperative care and follow up
Patient will be instructed to abstain from trauma on the operative site not to interfere with the suture and to avoid hot food or vigorous rinsing
The patients will be advised to refrain from brushing at the surgical area for the first day after surgery
A soft surgical brush will be dispensed for the cleaning of the surgical area after the initial healing phase during the first 2 weeks post surgically
Antibiotics and analgesics will be prescribed for 5 days
Patients will be instructed to
1 Follow the instructions completely
2 Keep up a strict follow-up schedule
3 Not to touch the surgical area with the tongue or fingers
4 Do not wear any kind of dental appliances on or around the surgical site
The sutures will be removed two weeks after the surgery On the first day postoperatively a baseline cone-beam computed tomography CBCT scan will be conducted A final follow-up visit and CBCT scan will be scheduled for six months postoperatively
Face to face adherence reminder session will take place to stress the post-operative instructions at the following time intervals
3 days and 7 days post-operatively for clinical assessment of swelling wound dehiscence and other adverse events
2 weeks after the operation for follow up
Lastly 6 months before implant placement
Radiographs
Radiographic alveolar bone changes of marginal bone loss primary outcome buccolingual ridge width BLRW buccal ridge height BRH and lingual ridge height LRH secondary outcomes will be assessed by an independent examiner RW on CBCT scans obtained at baseline and 6 months postoperatively
Histological analysis
For both groups test and control before the implant insertion the grafted site is to be exposed and biopsies from all sites will be excised using a trephine cylindrical drill graduated to indicate the depth from 5 to 18 mm with abundant irrigation using sterile saline Immediate preservation of biopsies in a 10 formalin solution and then sent for histologic analysis to be analyzed
Socket preservation is one of the techniques utilized to maintain bone dimension and minimized post-extraction dimensional changes Adding vitamin C to dentin graft and i-PRF might aid in reducing the dimensional changes and marginal bone loss since it increases osteoblast proliferation and viability during socket preservation By adding vitamin C with i-PRF we can add the advantages of improving soft tissue quality as well Layers of osteoblast cell morphology can be seen at day 11 with the presence of 25mM of vitamin C Moreover dentin graft is used as a cost-effective grafting material during socket preservation
l Inclusion criteria
18 years of age
Single extraction of non-molar teeth with periodontally healthy adjacent teeth
Non-contributory medial history
Non- restorable teeth indicated for extraction
Requiring alveolar preservation after tooth extraction prior to placement of dental implant
Participants that are eligible for immediate implantation yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction ex Financial related factors - psychological psychological factors - time related factors
Cooperative patients who are willing to commit for 6 months follow up
II Exclusion criteria
Pregnant female
Acute infection at extraction site
Systemic conditions affecting healing eg diabetes medications as bisphosphonates
A participant who had radiotherapy or chemotherapy
Psychiatric patient or with a learning disability or unable to give consent
Research Procedure in brief
The study is to be conducted in the Oral Medicine and Periodontology department Faculty of Dentistry- Cairo University EgyptPatients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology clinic of the department of Oral surgery and clinic of the department of Endodontics -Cairo University The initial therapy consists of periodontal treatment phase I therapy including supragingival scaling subgingival debridement if needed adjustment of faulty restoration and polishing The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques Rinsing with 012 chlorhexidine will be instructed
In both groups tooth extraction under local anesthesia with articaine HCL 2 120000 epinephrine will be performed Flapless minimally traumatic extraction will be done using thin periotomes and luxators After thorough mechanical cleaning the sockets will be rinsed with 5 ml of an aqueous 0125 chlorhexidine digluconate solution followed by a 5 ml sterile saline rinse to remove tissue debris from the socket This procedure will be repeated three times for each socket Followed by inspection of extraction socket integrity using a Williams graduated periodontal probe Then extracted teeth will be cleaned from periodontal ligaments cementum soft tissue attachment caries or restorations if present using a high-speed fine finishing stone and saline irrigation The pulp chamber will be cleaned with sterile endodontic files Subsequently teeth will be ground using hand bone mill
The demineralized autogenous tooth graft ADDG particles prepared by demineralization of tooth particles in 06N hydrochloric acid for 30 min to achieve demineralized then washed twice in saline and dried with sterile gauze
For i-PRF preparation blood will be withdrawn in plastic tubes without anticoagulant
In the intervention group 25mM of pure vitamin C will be added to the fresh blood and the tube will be centrifuged at around 700 RPM for 3 minutes
The extraction socket will be filled with the corresponding graft material and an absorbable gelatin sponge gelfoam will be used for socket and graft material coverage and secured using an internal crisscross knot using 5-0 monofilament polypropylene suture material
Postoperative care and follow up
Patient will be instructed to abstain from trauma on the operative site not to interfere with the suture and to avoid hot food or vigorous rinsing
The patients will be advised to refrain from brushing at the surgical area for the first day after surgery
A soft surgical brush will be dispensed for the cleaning of the surgical area after the initial healing phase during the first 2 weeks post surgically
Antibiotics and analgesics will be prescribed for 5 days
Patients will be instructed to
1 Follow the instructions completely
2 Keep up a strict follow-up schedule
3 Not to touch the surgical area with the tongue or fingers
4 Do not wear any kind of dental appliances on or around the surgical site
The sutures will be removed two weeks after the surgery On the first day postoperatively a baseline cone-beam computed tomography CBCT scan will be conducted A final follow-up visit and CBCT scan will be scheduled for six months postoperatively
Face to face adherence reminder session will take place to stress the post-operative instructions at the following time intervals
3 days and 7 days post-operatively for clinical assessment of swelling wound dehiscence and other adverse events
2 weeks after the operation for follow up
Lastly 6 months before implant placement
Radiographs
Radiographic alveolar bone changes of marginal bone loss primary outcome buccolingual ridge width BLRW buccal ridge height BRH and lingual ridge height LRH secondary outcomes will be assessed by an independent examiner RW on CBCT scans obtained at baseline and 6 months postoperatively
Histological analysis
For both groups test and control before the implant insertion the grafted site is to be exposed and biopsies from all sites will be excised using a trephine cylindrical drill graduated to indicate the depth from 5 to 18 mm with abundant irrigation using sterile saline Immediate preservation of biopsies in a 10 formalin solution and then sent for histologic analysis to be analyzed
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