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Bone Changes in Atrophic Maxilla Treated by Split-crest Technique

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ClinicalTrials.gov Identifier: NCT02836678
Recruitment Status : Unknown
Verified January 2017 by Maged Wadie Anis, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : July 19, 2016
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Maged Wadie Anis, Cairo University

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

Condition or disease Intervention/treatment Phase
Atrophy; Edentulous Ridge Biological: Ridge splitting, immediate implant, Nanobone with PRF. Biological: Ridge splitting, immediate implantand PRF. Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019
Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Horizontal bone gain in millimeters [ Time Frame: 5 month ]
    using Cone beam computed tomography


Secondary Outcome Measures :
  1. Post-operative pain Using Numerical rating scale [ Time Frame: 2 weeks ]
  2. Post-operative swelling Using Descriptive 4-point scale of swelling [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836678


Contacts
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Contact: Maged Anis, Assisstant lecturer 00201000618605 magedwadie@hotmail.com
Contact: Rasha Attia, Assisstant lecturer 00201009032255 periorasha1@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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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
More Information
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Publications:
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

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Responsible Party: Maged Wadie Anis, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT02836678    
Other Study ID Numbers: CEBD-2016-03-150
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical