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Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University.
- General operative procedures: The patients who fulfil the inclusion criteria will be enrolled. The nature of the study will be explained to each patient as well as the importance of compliance with pre- and post-operative instructions and follow-up visits. Each patient will be asked to sign an informed consent (appendix 1). 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 .
- Initial Therapy: The initial therapy will consist of periodontal treatment (phase I therapy) including supra-gingival 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.
Atraumatic extraction:
In intervention group, the partially demineralized dentin graft will be prepared as follows:
✓ The extracted tooth will be decontaminated and cleaned with a diamond bur under abundant irrigation with physiological water. All filling materials (gutta-percha, composite, luting cements, etc.) will be removed with the outmost care. Subsequently, the tooth will be cut into fragments (5 × 5 mm) and will be dried using air and ground with the Tooth Transformer device following the manufacturer's protocol. Dentin particles will be obtained with a dimension of 400 - 800 μm.
L-PRF membranes will be prepared as follows:
At the same time, L-PRF membranes will be prepared. Four 10-cc blood samples will be collected in vacutainer tubes without anticoagulant (red cap, glass coating) and immediately centrifuged at 2700 rpm (408g) for 12 min (IntraSpin, Intra- Lock, Florida, USA).
To 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 16 L-PRF pieces, forming a sturdy block known as the "dentin block," which serves as a convenient and compact graft.
Alveolar ridge preservation:
In the control group: The same procedure will be performed for preparing the L-PRF block by mixing the L-PRF membranes with xenograft.
Biopsy collection:
After a 4-months healing period, at the moment of the implant placement, a biopsy from the core of the grafted site will be obtained using a trephine bur with an outer diameter of 3 mm and an inner diameter of 2.2 mm. The biopsy will be immediately fixed in 10% neutral buffered formalin and then dehydrated through baths of progressively more concentrated (from 50 to 100%) alcohol and subsequently embedded in paraffin. Finally, a tissue section of 4-μm thick will be prepared and stained with hematoxylin-eosin for histological analysis.
- Late implant placement:
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 6 months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic vertical bone changes | 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 reference,the most apical point of the extraction socket will be identified on the baseline image, and two reference lines will be drawn. | after 6 months of the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic horizontal bone changes | CBCT scans will be performed at baseline and 6 months postoperatively. | after 6 months of the surgery |
| Percentage of new vital bone formation and residual graft |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manal Hosny, Professor | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry Cairo University | Cairo | Elmanil | 4240101 | Egypt |
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A Randomized Controlled Pilot Trial
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| 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. |
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The biopsies will be stored in a 10% formalin solution for preservation. Afterward, they will undergo decalcification in EDTA for a duration of four weeks. Following decalcification, the specimens will be processed and embedded in paraffin to create tissue blocks. Longitudinal sections of 5μm thickness will be cut from the paraffin blocks. These sections will be stained using hematoxylin and eosin (H&E) or Masson's trichromatic (MT) stains for histological evaluation and histomorphometric analysis. Photomicrographs of the stained sections will be captured using a digital light microscope (Leica Digital Microscope, Leica Microsystems, Germany).
| after 6 months of the surgery |
| Implant Primary Stability | will be assessed using the Osstell Mentor Resonance Frequency Analyzer (Osstell AB, Goteborg, Sweden). Two measurements will be taken in the buccolingual and mesiodistal directions for each implant. The average of these two measurements will be recorded as the representative implant stability quotient (ISQ) for each individual implant. | after 6 months of the surgery |