Alveolar Ridge Preservation After Tooth Extraction Using Autologous Dentin Matrix

NCT06541236 | Recruiting

• 1 other identifier: Autologous Dentin Matrix (CMF)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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% vertically.Despite 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.

Conditions

To Evaluate the Quality of the Newly Formed Cortical Tissue in the Area of the Condylar Condyle Using Different Bone Grafting Materials

Outcome Measures

Primary Outcomes (1)

• Level of bone persorption after Alveolar Ridge Preservation Using Autologous Dentin Matrix

  3 and 6 months after surgery

Study Arms (1)

Use of different bone grafting materials for alveolar ridge preservation of the socket

EXPERIMENTAL

All patients (n=80) 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 patient's 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

Procedure: Alveolar Ridge Preservation After Tooth Extraction Using Autologous Dentin Matrix

Interventions

Alveolar Ridge Preservation After Tooth Extraction Using Autologous Dentin Matrix PROCEDURE

Incorporation of various bone grafting materials for alveolar ridge preservation

Use of different bone grafting materials for alveolar ridge preservation of the socket

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included in the study, the treatment plan was discussed with each patient before surgery and an informed release form approved by the ethics committee was signed. Moreover, they met the following criteria: 1) Age from 18-70 years, 2) The presence of indications for tooth extraction: periapical periodontitis, fracture of the root or crown of the tooth without the possibility of rehabilitation, chronic periodontitis, 3) satisfactory oral hygiene.

You may not qualify if:

• Patients under 18 years of age, pregnant women, and patients with severe comor-bidity in the stage of decompensation were not included in the study.

Sponsors & Collaborators

• Moscow State University of Medicine and Dentistry: lead

Study Sites (1)

Moscow State Univerciry of medicine and dentistry

Moscow, 123022, Russia

RECRUITING

Central Study Contacts

Nikolai Redko, PhD

CONTACT

+79169544444; dr.redko@mail.ru

Alexei Drobyshev

CONTACT

+74956114336; 9544444n@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of maxillo-facial and plastic sutgery

Model Details: . The study included 80 patients in need of extraction of tooth and further dental im-plantation following proposed inclusion criteria. After selection, complex oral rehabil-itation was carried out to restore chewing function. All patients (n=80) were divided into 4 equal groups depending on the used preservative material.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: September 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)