Post Extraction Changes After Ridge Preservation Using Allogeneic Dentin Matrix Vs Demineralized Freeze Dried Allograft

NCT06318650 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-03-19

No results posted yet for this study

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 zone.Will 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 level,Change in the radiographic horizontal bone level,Percentage of new vital bone formation,Percentage of residual bone graft and Implant Primary Stability.

Conditions

  • Socket Preservation

Interventions

BIOLOGICAL

Demineralized Dentin Matrix

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 ) 2. (Quick Freezing with liquid nitrogen, then Grinding to particle size of 300- 800 μm). 3.(Ultrasonic Cleaning cycles, 1st with Distilled water , 2nd with 5-7% Hydrogen Perioxide then 3rd with Distilled water for at 60-80 o) 4. (Defatting with Chloroform Methanol Solution1:0.5. 5. (Demineralization with0.5N HCL) 6. (Dehydration with Neutral Ethyl Alcohol then Defatting with Chloroform Methanol Solution 1:0.5 for ) 7. (Washing with Normal Saline \& Freeze Drying then Sterilization using Ethylene oxide gas).

BIOLOGICAL

Demineralized freeze-dried bone allograft (DFDBA)

combination allograft, is a particulate bone graft combining 70% mineralized ground cortical with 30% demineralized ground cortical Particle sizing: 250 - 1000um.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Manal M. Hosny, Professor · Cairo University

  • Fatima M. Saleem Bin Nuhaid, Bachelor · Cairo University

  • Weam A. El-Battawy Study Chair, Ass. Prof. · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-06-01
Completion
2024-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06318650 on ClinicalTrials.gov