Post Extraction Changes Following Ridge Preservation Using Partially Demineralized Dentin Block Versus L- PRF Block

NCT06275490 | Recruiting DMC

• 1 other identifier: 181123PER6_3_1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

• The aim is to evaluate post extraction hard tissue changes following ridge preservation using partially demineralized dentin block versus L-PRF block in intact socket in the esthetic zone.
• The main question: In patients with un restorable tooth, Will ridge preservation using partially demineralized dentin block be more effective than L-PRF block in managing the post extraction hard tissue alterations?
• After enrolment, periodontal and radiographic examination and patients with badly un-restorative tooth in the esthetic zone will be identified. These patients will undergo to mesio-distal distance between adjacent teeth, corono-apical height of bone, presence of labial undercut, dehiscence, or fenestration and Relation to adjacent teeth measurements using trans gingival probing technique, and preapical radiograph or CBCT .
• In both groups, the desired tooth will be extracted under local anesthesia using peritomies and surgical forceps.
• In intervention group: the teeth will be cleaned and dried, and then the dentin will be ground to obtain particles of a certain size then partially demineralize dentin will obtained by using a tooth transformer machine. At the same time, blood samples are collected and processed to obtain fibrin membranes rich in platelets and leukocytes. This tissue is then mixed with partially demineralized dentin to create a solid mass called a "dentin block". During the process of preserving the alveolar bumps after extraction, this solid mass "dentin mass" is placed inside the dental pockets and covered with fibrin membranes rich in platelets and white blood cells, then 5/0 proline suture are used to fix the fibrin membranes and dentin mass in place. After the recovery period "4-6 months", a biopsy is taken for some cases from the site of the operation for histological evaluation during implant placement.
• In control group: the same steps as the first group will be used, but by replacing the partially demineralized dental graft with a xenograft.
• Outcomes: Radiographic vertical buccal bone changes, vertical Palatal bone changes, horizontal bone changes, Percentage of new vital bone formation, Percentage of residual bone graft, Implant Primary Stability. The results directly postoperative and 4-6 months postoperatively.

Conditions

Socket Preservation

Keywords

Socket Preservation; L-PRF block; Xenograft

Outcome Measures

Primary Outcomes (1)

• Radiographic vertical bone changes

  CBCT scans will be performed at baseline and 4-6 months postoperatively. Measurements will be taken at both time points using identical reference points and lines. To establish reference,the most apical point of the extraction socket will be identified on the baseline image, and two reference lines will be drawn.

  after 4-6 months of the surgery

Secondary Outcomes (3)

• Radiographic horizontal bone changes

  after 4-6 months of the surgery

• Percentage of new vital bone formation and residual graft

  after 4-6 months of the surgery

• Implant Primary Stability

  after 4-6 months of the surgery

Study Arms (2)

Partially Demineralized Dentin Block

EXPERIMENTAL

The extracted tooth will undergo grinding using the tooth transformer device. The produced dentin graft will be of a particle size 400-800 μm. Afterwards. -Prepare the partially demineralized dentin block, the L-PRF membranes will be cut into small pieces and mixed with the dentin particles at a ratio of 2 membranes to 0.5 g of dentin, providing a 1:1 volume ratio. The liquid fibrinogen will be added to the homogeneous mixture, and while shaping the mixture into the desired form it will be gently stirred for approximately 10 seconds. 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 a sturdy block known as the "dentin block," which serves as a convenient and compact graft .The extracted socket will be filled with partially demineralized autogenous dentin graft.

Biological: Partially Demineralized Dentin Block; Biological: L-PRF block

L- PRF Block

ACTIVE COMPARATOR

The same procedure will be performed for preparing the L-PRF block by mixing the L-PRF membranes with xenograft. In both groups, the placed graft will be covered with a L-PRF membrane .The L-PRF clots obtained after 12 min of centrifugation will be placed in the Xpression box (IntraSpin, Intra-Lock, Florida, USA) for 5 min to gently compress (by gravity) into membranes. Finally, tension free wound closure will be attained after periosteal releasing incision and suturing using 5/0 proline interrupted sutures. An immediate postoperative CBCT scan will be done following the surgical procedure.

Biological: Partially Demineralized Dentin Block; Biological: L-PRF block

Interventions

Partially Demineralized Dentin Block BIOLOGICAL

The extracted tooth will undergo grinding using the tooth transformer device. The produced dentin graft will be of a particle size 400-800 μm. Afterwards. -Prepare the partially demineralized dentin block, the L-PRF membranes will be cut into small pieces and mixed with the dentin particles at a ratio of 2 membranes to 0.5 g of dentin, providing a 1:1 volume ratio. The liquid fibrinogen will be added to the homogeneous mixture, and while shaping the mixture into the desired form it will be gently stirred for approximately 10 seconds. 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 a sturdy block known as the "dentin block," which serves as a convenient and compact graft .The extracted socket will be filled with partially demineralized autogenous dentin graft.

L- PRF Block; Partially Demineralized Dentin Block

L-PRF block BIOLOGICAL

The same procedure will be performed for preparing the L-PRF block by mixing the L-PRF membranes with xenograft. In both groups, the placed graft will be covered with a L-PRF membrane .The L-PRF clots obtained after 12 min of centrifugation will be placed in the Xpression box (IntraSpin, Intra-Lock, Florida, USA) for 5 min to gently compress (by gravity) into membranes.

L- PRF Block; Partially Demineralized Dentin Block

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged ≥18 years.
• Healthy individuals with no medical history.
• Patients who have a single non-restorable tooth in the esthetic zone.
• Post-extraction socket with four bone walls, the buccal plate is partially missing following extraction of the tooth. (Type II Extraction socket).
• Patients capable of understanding or signing the informed consent form before surgery and capable of meeting oral cleaning requirements for implant placement.

You may not qualify if:

• Systemic disease that might impair bone metabolism, antiresorptive therapy (as bisphosphonates),pregnancy, psychiatric conditions.
• Heavy smokers (\> 10 cigarettes)
• The presence of acute or chronic infection at the site of tooth extraction with lack of treatment for periodontal disease, or x-rays showing loss of alveolar bone on the adjacent teeth.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry Cairo University

Cairo, Elmanil, 4240101, Egypt

RECRUITING

Study Officials

• Manal Hosny, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Alaa Ah Al-Hazmi, Bachelor

CONTACT

+201271952129; alaa.alhazmi@dentistry.cu.edu.eg

Weam Eibattawy, 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 Alaa Ahmed

Model Details: A Randomized Controlled Pilot Trial

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 23, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 15, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-02

Locations

EG (1)