Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552793
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
Post Extraction Alterations Following Ridge Preservation In The Esthetic Zone Using Partially Demineralized Autogenous Dentine Graft Versus Xenograft
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Post Extraction Hard Tissue Alteration Following Ridge Preservation In The Esthetic Zone Using Partially Demineralized Autogenous Dentine Graft Versus Xenograft 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 this study is to establish if there are clinical radio-graphical and histomorphometrical differences between using Partially Demineralized Dentin graft versus Xenograft in the esthetic zone as a clinical application in alveolar bone regeneration procedures related to implant dentistry including socket preservation alveolar ridge augmentation after tooth extraction in the esthetic zone After extraction of non-restorable teeth in the esthetic zone will ridge preservation with application of partially demineralized autogenous dentin graft produce less hard tissue changes compared to xenograft
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 collagen membrane 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
Intervention group The socket will be filled with partially demineralized autogenous dentin graft Control group The socket will be filled with xenograft For both groups All the subjects will be evaluated at pre-surgical baseline and 6 months post surgical months for clinical parameters and baseline immediate post-surgical and 6 months post-surgical Outcomes Change in radiographic horizontal ridge width at 1mm below the most coronal aspect of the crest Change in radiographic horizontal ridge width at 3 and 5mm below the most coronal aspect of the crestChange in radiographic buccal ridge height Change in radiographic buccal ridge height Change in radiographic Palatal ridge heightPercentage of new vital bone formationPercentage of residual bone graftImplant Primary Stability
Detailed Description This study aims to evaluate clinical radiographic and histomorphometrica
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 collagen membrane 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
Intervention group The socket will be filled with partially demineralized autogenous dentin graft Control group The socket will be filled with xenograft For both groups All the subjects will be evaluated at pre-surgical baseline and 6 months post surgical months for clinical parameters and baseline immediate post-surgical and 6 months post-surgical Outcomes Change in radiographic horizontal ridge width at 1mm below the most coronal aspect of the crest Change in radiographic horizontal ridge width at 3 and 5mm below the most coronal aspect of the crestChange in radiographic buccal ridge height Change in radiographic buccal ridge height Change in radiographic Palatal ridge heightPercentage of new vital bone formationPercentage of residual bone graftImplant Primary Stability
Detailed Description This study aims to evaluate clinical radiographic and histomorphometrica
Detailed Description:
The study aims to radiographically evaluate the dimentionsal changes of hard tissue after application of partailly deminerlized dentin graft verus xenograft in the esthatic zone
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 surgical interventions Atraumatic extractionThe patient will rinse their mouth with 012 Chlorhexidine Administration of 4 articaine hydrochloride with 1100000 epinephrine will be as local anesthetic agentFlapless and atraumatic tooth extraction will be initiated using 15C blade intrasulcular incision will be performedA periotome will be utilized to sever the periodontal ligament PDL fibers followed by extraction witha straight elevator and extraction forceps
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 Tooth will be rinsed twice in phosphate buffered saline The tooth will be dried using air and ground with the Tooth Transformer device following the manufacturers protocol Dentin particles will be obtained with a dimension of 400 - 800 μm
Preparation of the autogenous partially demineralized dentin matrix
The extracted tooth will be cleaned with a diamond bur under abundant irrigation with physiological water All filling materials gutta-percha composite luting cements etc will be removed with the outmost care and under magnification
Subsequently the tooth will be cut into fragments 5 5 mm and inserted into the milling device According to the manufacturer a disposable box containing disposable liquid solutions will be inserted into the device to ensure the demineralization of the graft with 01 M hydrochloric acid 10 hydrogen peroxide and demineralized water as a wash
The decontamination of the granules will take place through UVA rays and ultrasounds with temperature variations always lower than 43 C to avoid damage to proteins
After 25 min particle graft biomaterials will be obtained The particles size will range from 815 µm with peaks up to 1110 µm
All bone defects will be filled with the graft obtained from the TT grinder
Device for Tooth Processing The Tooth Transformer TT
Part 1 Tooth Cleaning After extraction the tooth must be cleaned of tooth decay tartar soft tissue debris fillings cement and prosthetic components For the TT which calls for cutting the tooth into sections for the trituration stage
Part 2 Tooth Grinding The TT is equipped with a multipurpose sterilizable system that operates at low speed which makes it possible to avoid the loss of tooth substance during pulverisation despite the drawback of not being able to enter an entire tooth into the shredder
Part 3 Treatment by Device The shredder is closed and inserted once the tooth has been placed When the door is closed and the button is pressed a liquid cartridge and a cylinder with a granulate collection cup maker are placed into the apparatus in their respective housings the cartridge is activated by punching and the procedure starts
In control group
Xenograft will be prepared in a separate room to keep patients blinded where the allocated material will be administered 15 minutes after tooth extraction A xenograft will be implanted in the alveolus
Alveolar ridge preservation
Following a thorough cleaning procedure
Biopsy collection
After 6 months healing a local anesthesia will be given a full thickness mucoperiosteal flap will be detached in the augmented areas and a bone biopsy will be collected using a 4 mm trephine bur
Implant placement
After 6 months healing a local anesthesia will be given a full thickness mucoperiosteal flap will be detached in the augmented areas an implant placement with sequences drill will be done
Postoperative Care and follow up
Participants will be given instructions to avoid any trauma to the operative site refrain from interfering with the sutures and to avoid consuming hot food or engaging in vigorous rinsing
They will be encouraged to continue tooth brushing for the other parts of their dentition while gentle tooth brushing for the operative site will be advised to be resumed after a two-week period
Participants will be prescribed either Amoxicillin 500 mg Misr Co for Pharmaceutical Industries Egypt three times daily for seven days or doxycycline 100 mg Doxymycin Nile Co for Pharmaceuticals and Chemical Industries Egypt twice daily if they are sensitive to penicillin In case of severe pain Ibuprofen 600 mg Brufen Kahira Pharmaceuticals Egypt will be prescribed To facilitate gentle rinsing participants will be instructed to use a 012 Chlorhexidine mouthwash twice daily for a duration of two weeks
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
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 surgical interventions Atraumatic extractionThe patient will rinse their mouth with 012 Chlorhexidine Administration of 4 articaine hydrochloride with 1100000 epinephrine will be as local anesthetic agentFlapless and atraumatic tooth extraction will be initiated using 15C blade intrasulcular incision will be performedA periotome will be utilized to sever the periodontal ligament PDL fibers followed by extraction witha straight elevator and extraction forceps
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 Tooth will be rinsed twice in phosphate buffered saline The tooth will be dried using air and ground with the Tooth Transformer device following the manufacturers protocol Dentin particles will be obtained with a dimension of 400 - 800 μm
Preparation of the autogenous partially demineralized dentin matrix
The extracted tooth will be cleaned with a diamond bur under abundant irrigation with physiological water All filling materials gutta-percha composite luting cements etc will be removed with the outmost care and under magnification
Subsequently the tooth will be cut into fragments 5 5 mm and inserted into the milling device According to the manufacturer a disposable box containing disposable liquid solutions will be inserted into the device to ensure the demineralization of the graft with 01 M hydrochloric acid 10 hydrogen peroxide and demineralized water as a wash
The decontamination of the granules will take place through UVA rays and ultrasounds with temperature variations always lower than 43 C to avoid damage to proteins
After 25 min particle graft biomaterials will be obtained The particles size will range from 815 µm with peaks up to 1110 µm
All bone defects will be filled with the graft obtained from the TT grinder
Device for Tooth Processing The Tooth Transformer TT
Part 1 Tooth Cleaning After extraction the tooth must be cleaned of tooth decay tartar soft tissue debris fillings cement and prosthetic components For the TT which calls for cutting the tooth into sections for the trituration stage
Part 2 Tooth Grinding The TT is equipped with a multipurpose sterilizable system that operates at low speed which makes it possible to avoid the loss of tooth substance during pulverisation despite the drawback of not being able to enter an entire tooth into the shredder
Part 3 Treatment by Device The shredder is closed and inserted once the tooth has been placed When the door is closed and the button is pressed a liquid cartridge and a cylinder with a granulate collection cup maker are placed into the apparatus in their respective housings the cartridge is activated by punching and the procedure starts
In control group
Xenograft will be prepared in a separate room to keep patients blinded where the allocated material will be administered 15 minutes after tooth extraction A xenograft will be implanted in the alveolus
Alveolar ridge preservation
Following a thorough cleaning procedure
Biopsy collection
After 6 months healing a local anesthesia will be given a full thickness mucoperiosteal flap will be detached in the augmented areas and a bone biopsy will be collected using a 4 mm trephine bur
Implant placement
After 6 months healing a local anesthesia will be given a full thickness mucoperiosteal flap will be detached in the augmented areas an implant placement with sequences drill will be done
Postoperative Care and follow up
Participants will be given instructions to avoid any trauma to the operative site refrain from interfering with the sutures and to avoid consuming hot food or engaging in vigorous rinsing
They will be encouraged to continue tooth brushing for the other parts of their dentition while gentle tooth brushing for the operative site will be advised to be resumed after a two-week period
Participants will be prescribed either Amoxicillin 500 mg Misr Co for Pharmaceutical Industries Egypt three times daily for seven days or doxycycline 100 mg Doxymycin Nile Co for Pharmaceuticals and Chemical Industries Egypt twice daily if they are sensitive to penicillin In case of severe pain Ibuprofen 600 mg Brufen Kahira Pharmaceuticals Egypt will be prescribed To facilitate gentle rinsing participants will be instructed to use a 012 Chlorhexidine mouthwash twice daily for a duration of two weeks
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
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