Bone Changes in Atrophic Maxilla Treated by Split-crest Technique

Phase 2

• Conditions: Atrophy; Edentulous Ridge
• Interventions: Biological: Ridge splitting, immediate implant, Nanobone with PRF.; Biological: Ridge splitting, immediate implantand PRF.

• Registration Number: NCT02836678
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-19
• Status Verified: 2017-01
• Study Start: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16
• Primary Completion: 2018-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Ridge splitting, immediate implant, Nanobone with PRF.	Ridge splitting, immediate implant, Nanobone with PRF.
Control group	Ridge splitting, immediate implantand PRF.	Ridge splitting, immediate implantand PRF.

Primary Outcome Measures

Name	Time	Method
Horizontal bone gain in millimeters	5 month	using Cone beam computed tomography

Secondary Outcome Measures

Name	Time	Method
Post-operative swelling Using Descriptive 4-point scale of swelling	2 weeks
Post-operative pain Using Numerical rating scale	2 weeks