Bone Changes in Atrophic Maxilla Treated by Split-crest Technique
Primary Purpose
Atrophy; Edentulous Ridge
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ridge splitting, immediate implant, Nanobone with PRF.
Ridge splitting, immediate implantand PRF.
Sponsored by
About this trial
This is an interventional treatment trial for Atrophy; Edentulous Ridge
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Test group
Arm Description
Ridge splitting, immediate implantand PRF.
Ridge splitting, immediate implant, Nanobone with PRF.
Outcomes
Primary Outcome Measures
Horizontal bone gain in millimeters
using Cone beam computed tomography
Secondary Outcome Measures
Post-operative pain Using Numerical rating scale
Post-operative swelling Using Descriptive 4-point scale of swelling
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02836678
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy; Edentulous Ridge
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Ridge splitting, immediate implantand PRF.
Arm Title
Test group
Arm Type
Experimental
Arm Description
Ridge splitting, immediate implant, Nanobone with PRF.
Intervention Type
Biological
Intervention Name(s)
Ridge splitting, immediate implant, Nanobone with PRF.
Intervention Description
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).
Intervention Type
Biological
Intervention Name(s)
Ridge splitting, immediate implantand PRF.
Intervention Description
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).
Primary Outcome Measure Information:
Title
Horizontal bone gain in millimeters
Description
using Cone beam computed tomography
Time Frame
5 month
Secondary Outcome Measure Information:
Title
Post-operative pain Using Numerical rating scale
Time Frame
2 weeks
Title
Post-operative swelling Using Descriptive 4-point scale of swelling
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maged Anis, Assisstant lecturer
Phone
00201000618605
Email
magedwadie@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rasha Attia, Assisstant lecturer
Phone
00201009032255
Email
periorasha1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Zahran, Professor
Organizational Affiliation
Professor of Oral Medicine, Periodontology and Oral Diagnosis
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed Reda, Lecturer
Organizational Affiliation
Lecturer of Oral Medicine, Periodontology, and Oral Diagnosis
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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
Results Reference
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PubMed Identifier
14980425
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.
Results Reference
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Bone Changes in Atrophic Maxilla Treated by Split-crest Technique
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