Assessment Of Guided Bone Regeneration Using Xenograft Mixed With Allogenic Bone Graft Versus Xenograft Mixed With Autogenous Graft For Augmentation Of Maxillary Alveolar Ridges

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorCairo University

About this trial

This study aims to evaluate the effect of Allogenic bone graft mixed with Xenograft in ratio 1:1, on the radiographic and histomorphometric assessment versus Autologous bone graft mixed with Xenograft in ratio 1:1 in maxillary deficient ridges، In guided bone regeneration of deficient edentulous maxillary ridges, will the application of Xenograft mixed with Allograft (1:1) be as effective as Xenograft mixed with Autogenous graft (1:1) in terms of dimensional ridge changes and Quality of newly formed bone?

Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene and pathological conditions.

A full thickness flap will be elevated with two releasing incisions, decortication of the buccal aspect of the ridge, placing of grafting material which will be covered by collagen pericardium membranes, tacks placement at the labial side to fix the membrane in place, horizontal mattress sutures as well as single interrupted and continuous with resorbable sutures for closure.

Intervention group: will be filled with mixture of Xenogenic graft and the Allogenic bone graft chips.

Control group: will be filled with mixture of Xenogenic graft and Autogenous bone particulate harvested either the ramus.

For both groups, All the subjects will be taking CBCT at pre surgical and 6 months post surgical. outcomes : Bucco-Palatal horizontal bone gain, Alveolar ridge height, Percentage of new vital bone formation and Percentage of residual bone graft 6 months post-surgical.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 20-50 years.

Totally or partially edentulous maxillary ridges.

Patients with insufficient bone for an implant placement.

Residual alveolar width ranging from 2 to 4 mm.

Disqualifiers

Pathological lesions in the defect site.

Systemic diseases that would interfere with bone metabolism. Uncontrolled diabetic patients.

Ongoing treatment or a history of recent chemotherapy or radiotherapy.

Patient with medical condition that contraindicates surgical procedures.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Allogenic bone graft mixed with Xenograft in ratio 1:1

    Biological/Vaccine

    Xenogenic graft is then to be mixed in equal 1:1 volume of particles size 0.25-1 mm with the Allogenic bone graft chips to create 1:1 composite graft.

  • Autologous bone graft mixed with Xenograft in ratio 1:1

    Biological/Vaccine

    Autogenous bone particulate will be harvested from the mandibular ramus. Mandibular ramus as a donor site: A submarginal incision will be placed within the keratinized mucosa opposite to the lower first molar and extending 1 cm along the ramus of the mandible.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Allogenic bone graft mixed with Xenograft in ratio 1:1Experimental treatment 1 intervention
Group B: Autologous bone graft mixed with Xenograft in ratio 1:1Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bucco-Palatal horizontal bone gain

Bone width will be measured from the reformatted cross-sectional image of the CBCT 2 mm below the tip of the crest at every single deficient site taking a specific anatomical landmark in the opposing teeth as a reference point for the measurements taking into consideration that the patients are biting in maximum intercuspation. The average of these measurements will be calculated to be a representative value of the preoperative width for each case from the preoperative CBCT. Immediate and 6 months postoperative CBCT will be done while the patients are also biting in maximum intercuspation and the same measurements will be taken from the same reference areas previously selected from the preoperative scan.

Time frame
6 months postoperatively

Secondary outcomes

1

Alveolar ridge height:

It will be measured from the crest of the ridge to the nasal floor or sinus floor.

Time frame
6 months postoperatively
2

Percentage of new vital bone formation

core biopsies will be preserved in a 10% formalin solution. Following that, they will undergo four weeks of EDTA decalcification. The specimens will be treated and embedded in paraffin after decalcification to generate tissue blocks. The paraffin blocks will be split into longitudinal sections of 5m thickness. For histological examination and histomorphometric analysis, these slices will be stained with hematoxylin and eosin (H\&E) or Masson's trichromatic (MT) stains. A digital light microscope will be used to photograph the stained sections. Histomorphometric analysis will be undertaken to determine the percentage of the total analysed histological area occupied by bone, graft particles, and soft tissue stroma using (Leica QWin 500 image analysis software, Leica Microsystems, Switzerland).

Time frame
6 months postoperatively
3

Percentage of residual bone graft

core biopsies will be preserved in a 10% formalin solution. Following that, they will undergo four weeks of EDTA decalcification. The specimens will be treated and embedded in paraffin after decalcification to generate tissue blocks. The paraffin blocks will be split into longitudinal sections of 5m thickness. For histological examination and histomorphometric analysis, these slices will be stained with hematoxylin and eosin (H\&E) or Masson's trichromatic (MT) stains. A digital light microscope will be used to photograph the stained sections. Histomorphometric analysis will be undertaken to determine the percentage of the total analysed histological area occupied by bone, graft particles, and soft tissue stroma using (Leica QWin 500 image analysis software, Leica Microsystems, Switzerland).

Time frame
6 months postoperatively

Other outcomes

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