Clinical trial NCT02836678: Bone Changes in Atrophic Maxilla Treated by Split-crest Technique
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Atrophy; Edentulous Ridge
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Horizontal bone gain in millimeters
timeFrame: 5 month
Secondary outcomes:
measure: Post-operative pain Using Numerical rating scale
timeFrame: 2 weeks
measure: Post-operative swelling Using Descriptive 4-point scale of swelling
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Oral Medicine, Periodontology and Oral Diagnosis
name: Amr Zahran, Professor
role: STUDY_CHAIR
affiliation: Lecturer of Oral Medicine, Periodontology, and Oral Diagnosis
name: Ahmed Reda, Lecturer
role: STUDY_DIRECTOR
References:
citation: Gerber, T., Holzhüter, G., Knoblich, B., Dörfling, P., Bienengräber, V., & Henkel, K. O. (2000). Development of bioactive sol-gel material template for in vitro and in vivo synthesis of bone material. Journal of Sol-Gel Science and Technology, 19(1-3), 441-445. http://doi.org/10.1023/A:10087995
citation: Porter AE, Patel N, Skepper JN, Best SM, Bonfield W. Effect of sintered silicate-substituted hydroxyapatite on remodelling processes at the bone-implant interface. Biomaterials. 2004 Jul;25(16):3303-14. doi: 10.1016/j.biomaterials.2003.10.006.