Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541236
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Alveolar Ridge Preservation After Tooth Extraction Using Autologous Dentin Matrix
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Effectiveness of Autologous Dentin Matrix for Al-veolar Ridge Preservation
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:
ADM for ARP
Brief Summary:
According to the scientific literature the loss of any tooth can be accompanied by a pronounced resorption of the alveolar ridge in the corresponding area which leads to the formation of various defects In the post-extraction period bone tissue resorption 4 months after tooth extraction is up to 45 horizontally and 43 verticallyDespite the considerable amount of research on this problem the improvement of pre-implantation preparation of patients with adentia after tooth extraction continues to be an extremely urgent task The solution to this problem requires a comprehensive approach based on a unified assessment of the success of dental implantation in the post-extraction zone The aim of our study is to conduct a comprehensive comparative analysis of osteoplastic materials after preservation of the extraction wells of extracted teeth The null hypothesis is that the ADM technique can be used in patients and the newly formed bone regenerate will be sufficient for implant placement
Detailed Description:
The study was conducted in accordance with the rules and principles of evidence-based medicine in compliance with the requirements of the Declaration of Helsinki of the World Medical Association 2013 and was approved by the Interuniversity Committee on Ethics protocol No 04-18 dated April 19 2018
The recruitment of patients and their treatment was carried out within the framework of the University Clinic of A I Evdokimov Moscow State University of 67 from 2018 to 2020 Study type randomized clinical intervention prospective longitudinal study The study included 80 patients in need of extraction of tooth and further dental implantation following proposed inclusion criteria After selection complex oral rehabilitation was carried out to restore chewing function All patients n80 were divided into 4 equal groups depending on the used preservative material A total of 151 teeth were extracted In the 1st group the preservation was carried out using the Cerabone xenograft Botiss Germany In the 2nd group Plasma Rich in Growth Factors PRGF was used obtained from the patients venous blood 20-30 minutes before the tooth extraction BTI Endoret Spain The third group consisted of patients who underwent preservation of the extracted tooth socket with crushed autologous dentin matrix ADM obtained from their own tooth using Smart Dentin Grinder KometaBio Inc USA In the 4th group a material based on hydroxyapatite Kollapan-L with lincomycin Intermedapatit Russia was used as a preservation graft
4 months after tooth extraction dental implants were installed according to the standard ITI protocol Chen S Buser D 2007 In the postoperative period a standard course of antibacterial and anti-inflammatory therapy was carried out
The recruitment of patients and their treatment was carried out within the framework of the University Clinic of A I Evdokimov Moscow State University of 67 from 2018 to 2020 Study type randomized clinical intervention prospective longitudinal study The study included 80 patients in need of extraction of tooth and further dental implantation following proposed inclusion criteria After selection complex oral rehabilitation was carried out to restore chewing function All patients n80 were divided into 4 equal groups depending on the used preservative material A total of 151 teeth were extracted In the 1st group the preservation was carried out using the Cerabone xenograft Botiss Germany In the 2nd group Plasma Rich in Growth Factors PRGF was used obtained from the patients venous blood 20-30 minutes before the tooth extraction BTI Endoret Spain The third group consisted of patients who underwent preservation of the extracted tooth socket with crushed autologous dentin matrix ADM obtained from their own tooth using Smart Dentin Grinder KometaBio Inc USA In the 4th group a material based on hydroxyapatite Kollapan-L with lincomycin Intermedapatit Russia was used as a preservation graft
4 months after tooth extraction dental implants were installed according to the standard ITI protocol Chen S Buser D 2007 In the postoperative period a standard course of antibacterial and anti-inflammatory therapy was carried out
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