RecruitingNot ApplicableNCT06429540

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

Evaluation of Post Extraction Hard Tissue Alteration Following Ridge Preservation Using Partially Demineralized Dentin Block Versus Xenograft in the Esthetic Zone: A Randomized Controlled Clinical Trial

Sponsor

Cairo University

Enrollment

22 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Socket Preservation

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

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.

Exclusion Criteria5

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.

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Interventions

BIOLOGICALPartially Demineralized Dentin Block

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.

BIOLOGICALXenograft

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.