Bone Changes in Atrophic Maxilla Treated by Split-crest Technique

Study Overview
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Brief Summary
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The effect of adding Nanobone on horizontal bone gain in ridge splitting.

Detailed Description
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In cases of a very narrow ridge, One of the augmentation protocols is alveolar ridge-splitting techniques (RST) or alveolar ridge expansion techniques with simultaneous implant insertion. The piezoelectric surgical devices implemented for conducting bone osteotomy through the use of micrometric ultrasonic vibrations have been widely used in recent years in maxillofacial surgery. Its biggest advantages are that it allows for cutting with micrometric sensitivity while cutting hard tissues, it offers a clear vision of the surgical site due to its cavitation effect, it does not cause any damage to the soft tissues while performing these cuts, and that the bone tissue heals more quickly and seamlessly, after the cuts made by piezosurgery device. The fully synthetic bone substitute, NanoBone® (Artoss, Rostock, Germany), which will be applied in this clinical study, is basically a nanocrystalline hydroxyapatite embedded in a silica gel matrix, achieved by means of specific sol-gel techniques. Features such as interconnecting pores on the nanoscale, the open SiOH or SiO groups of polysilicic acid, its large internal surface, and the high porosity of this biomaterial are all related to the calcification processes observed within the implantation bed. While the HA component is responsible for NanoBone osteoconductive properties, the silica component is believed to induce connective tissue formation, osteoblast proliferation, bone matrix mineralization, and calcification, thus combining osteoconductive and osteoinductive properties. This phenomenon is associated with the rearrangement of the silica matrix, which could be observed in vivo.

Official Title
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Bone Changes in Atrophic Maxilla Treated by Split-crest Technique and Dental Implants With Platelet Rich Fibrin and Nanobone® Versus Platelet Rich Fibrin Alone; Randomized Controlled Trial

Conditions
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Atrophy; Edentulous Ridge

Intervention / Treatment
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* Biological: Ridge splitting, immediate implant, Nanobone with PRF.
* Biological: Ridge splitting, immediate implantand PRF.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-70. Patients with an edentulous site in maxilla. Ridge width of <6mm at the edentulous site. Ridge height of >9mm at the edentulous site. Patients who are compliant to oral hygiene measures for 4 weeks. Patient consent approval and signing. Exclusion Criteria: Smokers. Systemic disease that contraindicates implant placement or surgical procedures. No or poor patient's compliance. History of radio or chemo-therapy. Psychological problems. Pathology at the site of intervention. Pregnancy. Insufficient crown height space or mesio-distal dimension that contradict the placement of a dental implant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Ridge splitting, immediate implantand PRF. | Biological: Ridge splitting, immediate implantand PRF.<br>* Dental implant (is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis). PRF platelet rich fibrin. (second-generation Platelet rich plasma where autologous platelets and leucocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue).<br>|
| Experimental: Test group<br>Ridge splitting, immediate implant, Nanobone with PRF. | Biological: Ridge splitting, immediate implant, Nanobone with PRF.<br>* Dental implant (is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis). Alloplast bone graft material (Nanobone) PRF platelet rich fibrin. (second-generation Platelet rich plasma where autologous platelets and leucocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Horizontal bone gain in millimeters | using Cone beam computed tomography | 5 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain Using Numerical rating scale |  | 2 weeks | 
| Post-operative swelling Using Descriptive 4-point scale of swelling |  | 2 weeks |