Post Extraction Changes Following Ridge Preservation Using Partially Demineralized Dentin Block Versus Xenograft

NCT06429540 | Recruiting

• 1 other identifier: 12224PER6-3-1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to clinically and radiographically evaluate the dimensional changes of hard tissue after using Partially Demineralized Dentin Block versus Xenograft in the esthetic zone. The main question: In patients with unrestorable teeth, will the use of partially demineralized Dentin Block be more effective than Xenograft in preserving vertical and horizontal ridge dimensions? After enrollment, a thorough preoperative assessment, including history taking, clinical, and radiographic examinations, will be conducted. Initial therapy includes periodontal treatment (phase 1 therapy) followed by random assignment to one of two treatment groups: ridge preservation using Partially Demineralized Dentin Block or Xenograft. Both groups will undergo atraumatic extraction. For the test group, an autogenous partially demineralized dentin graft will be prepared, involving tooth cleaning, grinding, and partial demineralization with the Tooth Transformer device, followed by Leukocyte-Platelet Rich Fibrin (L-PRF) membrane and liquid fibrinogen preparation. The L-PRF membranes will be cut, mixed with dentin particles, and combined with liquid fibrinogen to form a compact graft. The block will be placed inside the socket and covered by an L-PRF membrane and secured with a cross-suture. In the control group, Xenograft will be used, and the socket filled with deproteinized bovine bone mineral, covered with a collagen membrane, and secured with a cross-suture. After a healing period of 6 months, at the time of implant placement, a biopsy will be taken using a trephine bur.

Conditions

Socket Preservation

Keywords

L-PRF; Xenograft; Collagen membrane; Dentin block; Partially demineralized dentin block; Socket preservation; Liquid fibrinogen

Outcome Measures

Primary Outcomes (1)

• Change in radiographic horizontal ridge width

  CBCT scans will be performed at baseline and 6 months postoperatively. Measurements will be taken at both time points using identical reference points and lines. To establish a reference, the most apical point of the extraction socket will be identified on the baseline image, and two reference lines will be drawn. The vertical reference line will be placed at the midpoint of the extraction socket, intersecting the apical reference point. Additionally, a horizontal reference line will be drawn perpendicular to the vertical line, passing through the apical reference point. The horizontal ridge width will be measured at three specific levels: 1 mm, 3 mm, and 5 mm below the most coronal aspect of the crest. These measurements will be denoted as HW-1, HW-3, and HW-5, respectively.

  at baseline and 6 months postoperatively

Secondary Outcomes (3)

• Change in radiographic buccal and palatal ridge height

  at baseline and 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)

Partially Demineralized Dentin Block

EXPERIMENTAL

The Partially Demineralized Dentin Block will be prepared using the Tooth Transformer device to grind the extracted tooth and partially demineralize it. Leukocyte-Platelet Rich Fibrin (L-PRF) and liquid fibrinogen will then be added to create a block graft.

Biological: Partially Demineralized Dentin Block

Xenograft

ACTIVE COMPARATOR

The Xenograft procedure will involve filling the socket with deproteinized bovine bone mineral, followed by the placement of a collagen membrane to cover the socket

Biological: Xenograft

Interventions

Partially Demineralized Dentin Block BIOLOGICAL

The extracted tooth will be dried using air, then ground and partially demineralized with the Tooth Transformer device following the manufacturer's protocol. Dentin particles will be obtained with dimensions of 400-800 μm. The partially demineralized dentin will then be prepared by cutting the Leukocyte-Platelet Rich Fibrin (L-PRF) membranes into small pieces and mixing them with the dentin particles. Liquid fibrinogen will be added to the homogeneous mixture. Within a few minutes, the fibrinogen will convert into fibrin primarily from the activated blood platelets in the chopped L-PRF membranes. This process will effectively trap the biomaterial and the L-PRF pieces, forming the "dentin block". After that, the sockets will be carefully packed with the dentin block and it will be covered with L-PRF membrane. To ensure stability and prevent displacement, the wounds will be secured using non-resorbable sutures.

Partially Demineralized Dentin Block

Xenograft BIOLOGICAL

In the control group using the Xenograft, the same extraction and socket debridement procedure will be performed. Following that, the extraction socket will be thoroughly filled with deproteinized bovine bone mineral, and a collagen membrane will be employed to cover the socket. The membrane will be shaped to extend 2-3 mm beyond the margins of the extraction socket and positioned just beneath the marginal mucosa. To ensure its stability, a cross-suture will be performed, securing the membrane in place.

Xenograft

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with non-restorable teeth and Type II extraction socket in the esthetic zone
• Healthy patients with adequate oral hygiene (bleeding on probing ≤20%; Plaque index ≤20%).
• Systemically healthy.

You may not qualify if:

• Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of \>6 mg/ml of nicotine).
• Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes).
• Patients with poor oral hygiene (bleeding on probing \>20%; Plaque index \>20%)
• The presence of acute periapical infection.
• The presence of severe periodontal destruction.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry Cairo University

Cairo, Elmanil, Egypt

RECRUITING

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Manal Hosny, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Danah Al Ghothani, Bachelor

CONTACT

1026826826; danah.tayseer@dentistry.cu.edu.eg

Weam Elbattawy, Ass. Prof

CONTACT

weamelbattawy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

EG (1)