Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318650
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-11
Brief Title:
Post Extraction Changes After Ridge Preservation Using Allogeneic Dentin Matrix Vs Demineralized Freeze Dried Allograft
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 Demineralized Freeze-Dried Bone Allograft A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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 establish if there are clinical radio-graphical and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft DFDBA 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 zoneWill ridge preservation using Allogeneic Dentin Matrix be more effective than Demineralized Freeze-Dried Bone Allograft in managing the post extraction hard tissue alterations
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 alginate impression will be taken to fabricate an acrylic stent to be used as reference for measurements of width of ridge clinically
Flapless and atraumatic tooth extraction will be initiated Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft DFDBA up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket criss-cross horizontal mattress suturing technique
Intervention group The socket will be filled with Allogeneic Dentin Matrix Control group The socket will be filled with Demineralized freeze-dried bone allograft DFDBA
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 ridge width clinically after 6 months Change in the radiographic buccal vertical bone level Change in the radiographic palatal vertical bone levelChange in the radiographic horizontal bone levelPercentage of new vital bone formationPercentage of residual bone graft and Implant Primary Stability
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 alginate impression will be taken to fabricate an acrylic stent to be used as reference for measurements of width of ridge clinically
Flapless and atraumatic tooth extraction will be initiated Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft DFDBA up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket criss-cross horizontal mattress suturing technique
Intervention group The socket will be filled with Allogeneic Dentin Matrix Control group The socket will be filled with Demineralized freeze-dried bone allograft DFDBA
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 ridge width clinically after 6 months Change in the radiographic buccal vertical bone level Change in the radiographic palatal vertical bone levelChange in the radiographic horizontal bone levelPercentage of new vital bone formationPercentage of residual bone graft and Implant Primary Stability
Detailed Description:
This study aims to evaluate clinical radiographic and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft DFDBA in alveolar ridge preservation after tooth extraction in the esthetic 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
Test group
preparation of Allogenic Demineralized Dentin Matrix Extracted teeth will be collected from the Departments of oral maxillofacial surgery and periodontics Cairo university Cleaning the teeth from any caries Filings cement tartar soft tissue debris and prosthetic components will be performed using a diamond bur under abundant irrigation with physiological water Then it will be proceeded to the following steps
1 Washing with Distilled water for 30-120 mins The dental root that has had its soft and pulp tissues removed is cleaned with distilled water for anywhere between 30 minutes and two hours The dental root includes residual dentin and cementum even though soft and pulp tissues have been removed
2 Quick Freezing with liquid nitrogen -160 o C for 30-120 mins Then Grinding to particle size of 300- 800 μm The dental root is processed into powder by quick-freezing and crushing the same method used for the dental crown with an average particle diameter of 200 mm to 1500 mm To eliminate impurities and remaining soft tissue the powder will be washed with distilled water for 30 minutes to 2 hours
3 Ultrasonic Cleaning cycles 1st with Distilled water for 5-10 mins 2nd with 5-7 Hydrogen Perioxide10-30 mins then 3rd with Distilled water for 5-10 mins at 60-80 o Each cycle of ultrasonic cleaning includes a first washing step in which the powder is processed with ultrasonic cleaning for about 5 minutes to about 10 minutes in pure water or sterilized distilled water a second washing step in which the powder is processed with ultrasonic cleaning for about 10 minutes to about 30 minutes in hydrogen peroxide solution and a third washing step in which the powder is processed with ultrasonic cleaning for about 10 minutes to about 30 minutes in hydrogen peroxide solution The concentration of the hydrogen peroxide solution is around 5 to 7 the volume of the washing fluid of each washing step is approximately 5 times to approximately 10 times that of the powder and the temperature of the washing fluid may be approximately 60C to 80C
4 Defatting with Chloroform Methanol Solution105 for 3-12 hours The powder cleaned in the preceding step can be largely degreased using a chloroform methanol solution with a chloroform to methanol weight ratio of about 105 to about 12 for 3 to 12 hours The largely degreased powder can be centrifuged to remove floating fat and rinsed with distilled water for at least 1 hour
5 Demineralization with05N HCL for 10-60 mins For about 10 minutes to about 1 hour the principally degreased powder is delimed Demineralized with about 05N hydrochloric acid aqueous solution whose volume is about 5 times to about 10 times that of the powder
6 Dehydration with Neutral Ethyl Alcohol for 30 mins then Defatting with Chloroform Methanol Solution 105 for 3-12 hours The delimed powder is next dehydrated with neutral ethyl alcohol for 30 minutes to 2 hours The dehydrated powder can be secondary degreased using a chloroform methanol solution with a chloroform to methanol weight ratio of approximately 105 to about 12 for 3 to 12 hours
7 Washing with Normal Saline Freeze Drying then Sterilization using Ethylene oxide gas The above-mentioned powder is degreased delimed and dehydrated before being post-treated with the steps of washing with normal saline solution and freeze-drying the degreased delimed and dehydrated powder and sterilization will be done using ethylene oxide gas
Alveolar ridge preservation
Following extraction curettes will be used to remove granulation tissues and the socket will be irrigated with sterile normal saline
Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft DFDBA in control group up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket Suturing technique will be a criss-cross horizontal mattress to ensure that most of the grafting material is covered
Postoperative Care and follow up
Participants will be instructed to avoid causing any damage to the operated site to prevent interfering with the sutures and to avoid consuming hot meals or vigorous rinsing
They will be encouraged to continue cleaning their teeth only avoiding the operated site Moderate tooth brushing for the operation site will be recommended after two weeks
Participants will be given Amoxicillin 500 mg three times a day for seven days or doxycycline 100 mg twice a day if they are penicillin sensitive
Ibuprofen 600 mg will be provided for severe pain
Participants will be asked to use a 012 Chlorhexidine mouthwash twice daily for two weeks to assist gentle rinsing
Sutures will be removed two weeks after the surgery
A baseline cone-beam computed tomography CBCT scan will be conducted on the same day postoperative A final follow-up visits and CBCT scan will be scheduled for six months postoperative to evaluate the dimensions of the alveolus before implant placement
Biopsy collection After a 6-months healing period a biopsy will be collected from the central area of the grafted site with a 3- mm trephine bur at the time of implant implantation The biopsy will be immediately fixed in 10 neutral buffered formalin followed by dehydration in a series of increasing concentration alcohol baths varying from 50 to 100 The specimen will then be encased in paraffin Finally a 4 m thick tissue section will be cut and stained with hematoxylin and eosin for subsequent histological investigation
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
Test group
preparation of Allogenic Demineralized Dentin Matrix Extracted teeth will be collected from the Departments of oral maxillofacial surgery and periodontics Cairo university Cleaning the teeth from any caries Filings cement tartar soft tissue debris and prosthetic components will be performed using a diamond bur under abundant irrigation with physiological water Then it will be proceeded to the following steps
1 Washing with Distilled water for 30-120 mins The dental root that has had its soft and pulp tissues removed is cleaned with distilled water for anywhere between 30 minutes and two hours The dental root includes residual dentin and cementum even though soft and pulp tissues have been removed
2 Quick Freezing with liquid nitrogen -160 o C for 30-120 mins Then Grinding to particle size of 300- 800 μm The dental root is processed into powder by quick-freezing and crushing the same method used for the dental crown with an average particle diameter of 200 mm to 1500 mm To eliminate impurities and remaining soft tissue the powder will be washed with distilled water for 30 minutes to 2 hours
3 Ultrasonic Cleaning cycles 1st with Distilled water for 5-10 mins 2nd with 5-7 Hydrogen Perioxide10-30 mins then 3rd with Distilled water for 5-10 mins at 60-80 o Each cycle of ultrasonic cleaning includes a first washing step in which the powder is processed with ultrasonic cleaning for about 5 minutes to about 10 minutes in pure water or sterilized distilled water a second washing step in which the powder is processed with ultrasonic cleaning for about 10 minutes to about 30 minutes in hydrogen peroxide solution and a third washing step in which the powder is processed with ultrasonic cleaning for about 10 minutes to about 30 minutes in hydrogen peroxide solution The concentration of the hydrogen peroxide solution is around 5 to 7 the volume of the washing fluid of each washing step is approximately 5 times to approximately 10 times that of the powder and the temperature of the washing fluid may be approximately 60C to 80C
4 Defatting with Chloroform Methanol Solution105 for 3-12 hours The powder cleaned in the preceding step can be largely degreased using a chloroform methanol solution with a chloroform to methanol weight ratio of about 105 to about 12 for 3 to 12 hours The largely degreased powder can be centrifuged to remove floating fat and rinsed with distilled water for at least 1 hour
5 Demineralization with05N HCL for 10-60 mins For about 10 minutes to about 1 hour the principally degreased powder is delimed Demineralized with about 05N hydrochloric acid aqueous solution whose volume is about 5 times to about 10 times that of the powder
6 Dehydration with Neutral Ethyl Alcohol for 30 mins then Defatting with Chloroform Methanol Solution 105 for 3-12 hours The delimed powder is next dehydrated with neutral ethyl alcohol for 30 minutes to 2 hours The dehydrated powder can be secondary degreased using a chloroform methanol solution with a chloroform to methanol weight ratio of approximately 105 to about 12 for 3 to 12 hours
7 Washing with Normal Saline Freeze Drying then Sterilization using Ethylene oxide gas The above-mentioned powder is degreased delimed and dehydrated before being post-treated with the steps of washing with normal saline solution and freeze-drying the degreased delimed and dehydrated powder and sterilization will be done using ethylene oxide gas
Alveolar ridge preservation
Following extraction curettes will be used to remove granulation tissues and the socket will be irrigated with sterile normal saline
Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft DFDBA in control group up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket Suturing technique will be a criss-cross horizontal mattress to ensure that most of the grafting material is covered
Postoperative Care and follow up
Participants will be instructed to avoid causing any damage to the operated site to prevent interfering with the sutures and to avoid consuming hot meals or vigorous rinsing
They will be encouraged to continue cleaning their teeth only avoiding the operated site Moderate tooth brushing for the operation site will be recommended after two weeks
Participants will be given Amoxicillin 500 mg three times a day for seven days or doxycycline 100 mg twice a day if they are penicillin sensitive
Ibuprofen 600 mg will be provided for severe pain
Participants will be asked to use a 012 Chlorhexidine mouthwash twice daily for two weeks to assist gentle rinsing
Sutures will be removed two weeks after the surgery
A baseline cone-beam computed tomography CBCT scan will be conducted on the same day postoperative A final follow-up visits and CBCT scan will be scheduled for six months postoperative to evaluate the dimensions of the alveolus before implant placement
Biopsy collection After a 6-months healing period a biopsy will be collected from the central area of the grafted site with a 3- mm trephine bur at the time of implant implantation The biopsy will be immediately fixed in 10 neutral buffered formalin followed by dehydration in a series of increasing concentration alcohol baths varying from 50 to 100 The specimen will then be encased in paraffin Finally a 4 m thick tissue section will be cut and stained with hematoxylin and eosin for subsequent histological investigation
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