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

NCT06318650 | Recruiting DMC

• 1 other identifier: 19124PER6_3_1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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 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

Keywords

Socket preservation; Ridge preservation; Allogeneic dentin matrix; Demineralized freeze dried bone allograft; DFDBA

Outcome Measures

Primary Outcomes (1)

• Change in Ridge width over 6 months

  Before surgical intervention, baseline and 6-month postoperative examination will be conducted. Before surgical procedure ridge width will be measured using caliper, a resin acrylic stent will be placed measurements of 3mm and 5mm from gingival margin will be marked and measures the ridge width through it, this will be repeated after extraction (baseline) and 6 months postoperative.

  after 6 months postoperatively

Secondary Outcomes (4)

• Change in the radiographic vertical bone level

  after 6 months postoperatively

• Change in the radiographic horizontal bone level

  after 6 months postoperatively

• Percentage of new vital bone formation and residual graft

  after 6 months postoperatively

• Implant Primary Stability

  after 6 months postoperatively

Study Arms (2)

Allogenic Demineralized Dentin Matrix

EXPERIMENTAL

Following atraumatic tooth 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 with Allogeneic Dentin Matrix (that has been prepared before) 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.

Biological: Demineralized Dentin Matrix

Demineralized Freeze-Dried Bone Allograft

ACTIVE COMPARATOR

Following atraumatic tooth 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 with Demineralized freeze-dried bone allograft (DFDBA) 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.

Biological: Demineralized freeze-dried bone allograft (DFDBA)

Interventions

Demineralized Dentin Matrix BIOLOGICAL

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).

Allogenic Demineralized Dentin Matrix

Demineralized freeze-dried bone allograft (DFDBA) BIOLOGICAL

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

Demineralized Freeze-Dried Bone Allograft

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients between the age of 20-55.
• Single rooted, non-restorable or hopeless tooth with adjacent teeth.
• Extraction socket with no more than 50% buccal bone loss
• Patients accept 6-months follow-up period (cooperative patients).
• Patients provide an informed consent.

You may not qualify if:

• Patients with uncontrolled systemic disease.
• Patient with severe para-functional habits.
• Patients with poor maintenance of oral hygiene.
• Pregnancy.
• Smokers.
• Patients taking any medications that could compromise healing.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Demineralized Dentin Matrix

Study Officials

• Manal M. Hosny, Professor

  Cairo University

  STUDY DIRECTOR

• Fatima M. Saleem Bin Nuhaid, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

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

  Cairo University

  STUDY CHAIR

Central Study Contacts

Fatima M. Saleem Bin Nuhaid, Bachelor

CONTACT

+201017873596; fatima.mubarak@dentistry.cu.edu.eg

Weam El-Battawy, Ass. Prof.

CONTACT

weamelbattawy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Fatima Mubarak Master Degree student, Periodontology department, Faculty of Dentistry, Cairo University

Model Details: A Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 19, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

EG (1)