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

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

Study Overview

• Status: Unknown
• Conditions: Atrophy; Edentulous Ridge
• Intervention / Treatment: Biological: Ridge splitting, immediate implantand PRF.; Biological: Ridge splitting, immediate implant, Nanobone with PRF.

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control group; Ridge splitting, immediate implantand PRF.	Biological: Ridge 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).
EXPERIMENTAL: Test group; Ridge splitting, immediate implant, Nanobone with PRF.	Biological: Ridge 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Amr Zahran, Professor, Professor of Oral Medicine, Periodontology and Oral Diagnosis; Study Director: Ahmed Reda, Lecturer, Lecturer of Oral Medicine, Periodontology, and Oral Diagnosis

Publications and helpful links

General Publications

• 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.
• 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

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (ESTIMATE): July 19, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): January 16, 2017
• Last Update Submitted That Met QC Criteria: January 13, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: CEBD-2016-03-150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED