Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477887
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-05
Brief Title:
Post Extraction Changes Following Ridge Preservation Using Allogenis Dentin Vs Autogenous Partially Demineralized Dentin
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Evaluation Of Post Extraction Hard Tissue Alteration Following Ridge Preservation in The Esthetic Zone Using Allogeneic Dentin Matrix Versus Autogenous Partially Demineralized Dentine Matrix 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:
Research question
In patients with unrestorable anterior teeth will the use of allogenic dentin matrix be more effective than autogenous partially demineralized dentine matrix APDDM in reducing hard tissue changes after post-extraction ridge preservation in the aesthetic zone After enrolment periodontal and radiographic examinations will be conducted and patients with badly unrestorable teeth in the aesthetic zone will be identified These patients will undergo measurements of mesio-distal distance between adjacent teeth corono-apical height of bone the presence of a labial undercut dehiscence or fenestration and the relationship to adjacent teeth using the transgival probing technique and a preapical radiograph or CBCT
In both groups the desired tooth will be atraumatically extracted under local anaesthesia using peritomies and surgical forceps
In the intervention group preparation of the allogenic dentin matrix
Steps of Allogenic Dentin Processing
Washing with distilled water for 30-120 minutes Ultrasonic cleaning cycles 1st with distilled water for 5-10 minutes 2nd with 5-7 hydrogen peroxide 10-30 minutes then 3 minutes with distilled water for 5-10 minutes at 60-80 Defatting with Chloroform Methanol Solution 105 for 3-12 hours Demineralization with 05 HCL for 10-60 min Dehydration with Neutral Ethyl Alcohol for 30 minutes then defatting with Chloroform Methanol Solution 105 for 3-12 hours Washing with normal saline and freeze-drying then sterilisation using ethylene oxide gas
After the recovery period of 6 months a biopsy is taken for cases from the site of the operation for histological evaluation during implant placement
In the control group the teeth will be cleaned and dried and then the dentin will be ground to obtain particles of a certain size which will be partially demineralized by using a tooth transformer machine In both groups the dentin graft will be placed inside the socket and then a 50 proline suture will be used to fix the collagen membranes to cover the graft After the recovery period of 6 months a biopsy is taken for cases from the site of the operation for histological evaluation during implant placement
Outcome
Radiographic bucco-lingual ridge width loss Radiographic palatal vertical bone changes Radiographic buccal vertical bone changes Percentage of new vital bone formation Percentage of residual bone graft Implant Primary Stability
In patients with unrestorable anterior teeth will the use of allogenic dentin matrix be more effective than autogenous partially demineralized dentine matrix APDDM in reducing hard tissue changes after post-extraction ridge preservation in the aesthetic zone After enrolment periodontal and radiographic examinations will be conducted and patients with badly unrestorable teeth in the aesthetic zone will be identified These patients will undergo measurements of mesio-distal distance between adjacent teeth corono-apical height of bone the presence of a labial undercut dehiscence or fenestration and the relationship to adjacent teeth using the transgival probing technique and a preapical radiograph or CBCT
In both groups the desired tooth will be atraumatically extracted under local anaesthesia using peritomies and surgical forceps
In the intervention group preparation of the allogenic dentin matrix
Steps of Allogenic Dentin Processing
Washing with distilled water for 30-120 minutes Ultrasonic cleaning cycles 1st with distilled water for 5-10 minutes 2nd with 5-7 hydrogen peroxide 10-30 minutes then 3 minutes with distilled water for 5-10 minutes at 60-80 Defatting with Chloroform Methanol Solution 105 for 3-12 hours Demineralization with 05 HCL for 10-60 min Dehydration with Neutral Ethyl Alcohol for 30 minutes then defatting with Chloroform Methanol Solution 105 for 3-12 hours Washing with normal saline and freeze-drying then sterilisation using ethylene oxide gas
After the recovery period of 6 months a biopsy is taken for cases from the site of the operation for histological evaluation during implant placement
In the control group the teeth will be cleaned and dried and then the dentin will be ground to obtain particles of a certain size which will be partially demineralized by using a tooth transformer machine In both groups the dentin graft will be placed inside the socket and then a 50 proline suture will be used to fix the collagen membranes to cover the graft After the recovery period of 6 months a biopsy is taken for cases from the site of the operation for histological evaluation during implant placement
Outcome
Radiographic bucco-lingual ridge width loss Radiographic palatal vertical bone changes Radiographic buccal vertical bone changes Percentage of new vital bone formation Percentage of residual bone graft Implant Primary Stability
Detailed Description:
This study aims to evaluate the radiographical and histomorphometrical differences between the allogenic dentin matrix and the autogenous partially demineralized dentin matrix APDDM in ridge preservation after tooth extraction in the aesthetic 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 The patients who fulfil the inclusion criteria will be enrolled The nature of the study will be explained to each patient as follows as well as the importance of compliance with pre- and post-operative instructions
and follow-up visits Each patient will be asked to sign an informed consent form After enrolment periodontal and radiographic examination and Patients with badly unrestorable teeth in the aesthetic zone will be identified
These patients will undergo mesio-distal distance between adjacent teeth corono-apical height of bone presence of labial undercut dehiscence or fenestration and relation to adjacent teeth measurements using transgival probing technique and a preapical radiograph or CBCT Initial Therapy The initial therapy will consist of periodontal treatment phase I therapy including supra-gingival scaling and subgingival debridement if needed adjustment of faulty restoration and polishing The mechanical plaque Control instructions for each patient include brushing and interdental cleaning
techniques
Atraumatic extraction
Local anaesthesia will be administered via buccal and palatal infiltration prior to any surgical procedure
In both groups flapless atraumatic tooth extraction will be performed which includes an intrasulcular incision using a 15c blade then a The periotome is inserted between the root and the surrounding bone in a wedging action on all sides around the root Afterwards a small A straight elevator will be used to luxate the root and the remaining root Forceps will be used to deliver it Lucas Curette will be used to clean the extraction socket of any apical pathology and granulation tissue
In the intervention group 2 Group 1 an allogeneic dentin matrix will be used
Preparation of the allogenic dentin matrix
Steps of Allogenic Dentin Processing
Washing with distilled water for 30-120 mins Soft and pulp tissues are to be removed from the dental root then washed with distilled water for about 30 minutes to about 2 hours
Quick Freezing with Liquid Nitrogen at 160 oC for 30-120 min Then grind to a particle size of 300-800 µm
The dental root will be processed by quick-freezing and crushing into powder whose average particle diameter is about 200 mm to about 1500 mm The powder may be washed with distilled water for about 30 minutes to about 2 hours to remove contaminants and residual soft tissue
Ultrasonic cleaning cycles 1st with distilled water for 5-10 minutes 2nd with 5-7 hydrogen peroxide 10-30 minutes then 3 minutes with distilled water for 5-10 minutes at 60-80 The powder will be cleaned using three cycles of ultrasonic cleaning each of which consists of the following steps a first washing step in which the powder will be cleaned using ultrasonic technology for about five to ten minutes in sterilised or clean water a second washing step in which the powder will be cleaned using ultrasonic technology for about ten to thirty minutes in hydrogen peroxide solution and a third washing step in which the powder will be cleaned using ultrasonic technology for about five to ten minutes in pure water
Defatting with Chloroform Methanol Solution 105 for 3-12 hours The powder washed in the above-described step will be primarily degreased using a chloroform-methanol solution where the ratio between the chloroform and methanol is about 105 to about 12 by weight for about 3 hours to about 12 hours
Demineralization with 05 N HCL for 10-60 min The above-mentioned powder that has been principally degreased will be delimed demineralized for 10 minutes to an hour in an aqueous solution of about 05N hydrochloric acid that has a volume that is 5-10 times more than that of the powder
Dehydration with Neutral Ethyl Alcohol for 30 minutes then Defatting with Chloroform Methanol Solution 105 for 3-12 hours The deli powder will next be dehydrated for up to two hours with neutral ethyl alcohol The dehydrated powder may undergo a second degreasing step using a chloroform-methanol solution with a chloroform-to-methanol weight ratio of about 105 to about 12 over a duration of about 3 hours to about 12 hours
Washing with normal saline and freeze drying then sterilisation using ethylene oxide gas The degreased delimed and dehydrated powders are then freeze-dried and the freeze-dried powders are then sterilised using ethylene oxide gas
In the control group the partially demineralized dentin graft will be prepared as follows The extracted tooth will be decontaminated and cleaned with a diamond under abundant irrigation with physiological water All filling materials gutta-percha composite luting cements etc will be removed with the outmost care Subsequently the tooth will be cut into fragments 5 5 mm and 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
Alveolar ridge preservation
After socket debridement each socket will be carefully filled with dentin graft
Once the grafts are properly adapted to the sockets they will be covered with collagen membranes extending 2 mm in the envelope prepared between the periosteum
and the bony borders of the socket 360 around The wound will be secured using 50 proline interrupted sutures not with the intention to close the wound but simply to keep the graft and membranes are stable in position After a 6-month healing period at the moment of the implant placement a A biopsy from the core of the grafted site will be obtained using a 2-mm trephine
bur The biopsy will be immediately fixed in 10 neutral buffered formalin and then dehydrated through baths of progressively more concentrated water from 50 to 100 alcohol and subsequently embedded in paraffin Finally a tissue A section of 4 μm thick will be prepared and stained with hematoxylin-eosin for histological analysis
Late implant placement
After complete bone healing of the extraction socket 6 months following tooth extraction and late implant placement will be performed
Local anaesthesia in which Septocaine Articaine hydrochloride 4 with 1100000 Epinephrine will be administered via buccal and palatal infiltration prior to any surgical procedure For both groups a triangular flap design will be used which involves a midcrestal horizontal incision with an intrasulcular incision on each distal tooth to the edentulous area Then two vertical releases Incisions will be made at the line angles of the adjacent teeth This will be followed by full-thickness flap elevation
The implant osteotomy will then be prepared using sequential drilling according to to the manufacturers instructions to allow implant placement in proper 3D prosthetic Finally the implant will be inserted into the prepared osteotomy
Outcome
Radiographic bucco-lingual ridge width loss Radiographic palatal vertical bone changes Radiographic buccal vertical bone changes Percentage of new vital bone formation Percentage of residual bone graft Implant Primary Stability The results were directly postoperative and 6 months postoperatively
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 The patients who fulfil the inclusion criteria will be enrolled The nature of the study will be explained to each patient as follows as well as the importance of compliance with pre- and post-operative instructions
and follow-up visits Each patient will be asked to sign an informed consent form After enrolment periodontal and radiographic examination and Patients with badly unrestorable teeth in the aesthetic zone will be identified
These patients will undergo mesio-distal distance between adjacent teeth corono-apical height of bone presence of labial undercut dehiscence or fenestration and relation to adjacent teeth measurements using transgival probing technique and a preapical radiograph or CBCT Initial Therapy The initial therapy will consist of periodontal treatment phase I therapy including supra-gingival scaling and subgingival debridement if needed adjustment of faulty restoration and polishing The mechanical plaque Control instructions for each patient include brushing and interdental cleaning
techniques
Atraumatic extraction
Local anaesthesia will be administered via buccal and palatal infiltration prior to any surgical procedure
In both groups flapless atraumatic tooth extraction will be performed which includes an intrasulcular incision using a 15c blade then a The periotome is inserted between the root and the surrounding bone in a wedging action on all sides around the root Afterwards a small A straight elevator will be used to luxate the root and the remaining root Forceps will be used to deliver it Lucas Curette will be used to clean the extraction socket of any apical pathology and granulation tissue
In the intervention group 2 Group 1 an allogeneic dentin matrix will be used
Preparation of the allogenic dentin matrix
Steps of Allogenic Dentin Processing
Washing with distilled water for 30-120 mins Soft and pulp tissues are to be removed from the dental root then washed with distilled water for about 30 minutes to about 2 hours
Quick Freezing with Liquid Nitrogen at 160 oC for 30-120 min Then grind to a particle size of 300-800 µm
The dental root will be processed by quick-freezing and crushing into powder whose average particle diameter is about 200 mm to about 1500 mm The powder may be washed with distilled water for about 30 minutes to about 2 hours to remove contaminants and residual soft tissue
Ultrasonic cleaning cycles 1st with distilled water for 5-10 minutes 2nd with 5-7 hydrogen peroxide 10-30 minutes then 3 minutes with distilled water for 5-10 minutes at 60-80 The powder will be cleaned using three cycles of ultrasonic cleaning each of which consists of the following steps a first washing step in which the powder will be cleaned using ultrasonic technology for about five to ten minutes in sterilised or clean water a second washing step in which the powder will be cleaned using ultrasonic technology for about ten to thirty minutes in hydrogen peroxide solution and a third washing step in which the powder will be cleaned using ultrasonic technology for about five to ten minutes in pure water
Defatting with Chloroform Methanol Solution 105 for 3-12 hours The powder washed in the above-described step will be primarily degreased using a chloroform-methanol solution where the ratio between the chloroform and methanol is about 105 to about 12 by weight for about 3 hours to about 12 hours
Demineralization with 05 N HCL for 10-60 min The above-mentioned powder that has been principally degreased will be delimed demineralized for 10 minutes to an hour in an aqueous solution of about 05N hydrochloric acid that has a volume that is 5-10 times more than that of the powder
Dehydration with Neutral Ethyl Alcohol for 30 minutes then Defatting with Chloroform Methanol Solution 105 for 3-12 hours The deli powder will next be dehydrated for up to two hours with neutral ethyl alcohol The dehydrated powder may undergo a second degreasing step using a chloroform-methanol solution with a chloroform-to-methanol weight ratio of about 105 to about 12 over a duration of about 3 hours to about 12 hours
Washing with normal saline and freeze drying then sterilisation using ethylene oxide gas The degreased delimed and dehydrated powders are then freeze-dried and the freeze-dried powders are then sterilised using ethylene oxide gas
In the control group the partially demineralized dentin graft will be prepared as follows The extracted tooth will be decontaminated and cleaned with a diamond under abundant irrigation with physiological water All filling materials gutta-percha composite luting cements etc will be removed with the outmost care Subsequently the tooth will be cut into fragments 5 5 mm and 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
Alveolar ridge preservation
After socket debridement each socket will be carefully filled with dentin graft
Once the grafts are properly adapted to the sockets they will be covered with collagen membranes extending 2 mm in the envelope prepared between the periosteum
and the bony borders of the socket 360 around The wound will be secured using 50 proline interrupted sutures not with the intention to close the wound but simply to keep the graft and membranes are stable in position After a 6-month healing period at the moment of the implant placement a A biopsy from the core of the grafted site will be obtained using a 2-mm trephine
bur The biopsy will be immediately fixed in 10 neutral buffered formalin and then dehydrated through baths of progressively more concentrated water from 50 to 100 alcohol and subsequently embedded in paraffin Finally a tissue A section of 4 μm thick will be prepared and stained with hematoxylin-eosin for histological analysis
Late implant placement
After complete bone healing of the extraction socket 6 months following tooth extraction and late implant placement will be performed
Local anaesthesia in which Septocaine Articaine hydrochloride 4 with 1100000 Epinephrine will be administered via buccal and palatal infiltration prior to any surgical procedure For both groups a triangular flap design will be used which involves a midcrestal horizontal incision with an intrasulcular incision on each distal tooth to the edentulous area Then two vertical releases Incisions will be made at the line angles of the adjacent teeth This will be followed by full-thickness flap elevation
The implant osteotomy will then be prepared using sequential drilling according to to the manufacturers instructions to allow implant placement in proper 3D prosthetic Finally the implant will be inserted into the prepared osteotomy
Outcome
Radiographic bucco-lingual ridge width loss Radiographic palatal vertical bone changes Radiographic buccal vertical bone changes Percentage of new vital bone formation Percentage of residual bone graft Implant Primary Stability The results were directly postoperative and 6 months postoperatively
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