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Bone Changes in Atrophic Maxilla Treated by Split-crest Technique

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02836678
Enrollment
40
Registered
2016-07-19
Start date
2017-01-31
Completion date
2019-09-30
Last updated
2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophy; Edentulous Ridge

Brief summary

The effect of adding Nanobone on horizontal bone gain in ridge splitting.

Detailed description

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.

Interventions

BIOLOGICALRidge splitting, immediate implant, Nanobone with PRF.

* 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).

BIOLOGICALRidge splitting, immediate implantand PRF.

* 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).

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Horizontal bone gain in millimeters5 monthusing Cone beam computed tomography

Secondary

MeasureTime frame
Post-operative pain Using Numerical rating scale2 weeks
Post-operative swelling Using Descriptive 4-point scale of swelling2 weeks

Contacts

Primary ContactMaged Anis, Assisstant lecturer
magedwadie@hotmail.com00201000618605
Backup ContactRasha Attia, Assisstant lecturer
periorasha1@gmail.com00201009032255

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026