Back to resultsAscending Ramus Versus Chin Cortical Plates for Reconstruction of Atrophic Maxilla
Primary Purpose
Atrophy of Edentulous Maxillary Alveolar Ridge
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Atrophic maxillary alveolar ridge augmentation
Sponsored by
About this trial
This is an interventional health services research trial for Atrophy of Edentulous Maxillary Alveolar Ridge focused on measuring Atrophic, augmetation, bone regeneration
Eligibility Criteria
Inclusion Criteria:
- Patients with atrophic maxilla with residual bone height from 3 to 4mm.
- Both sexes
Exclusion Criteria:
- Intraoral soft and hard tissue pathology.
- Systemic condition that contraindicate implant basement.
- Psychiatric problems
Sites / Locations
- Faculty of Dentistry, Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ascending ramus group
Chin Group
Arm Description
Local anesthesia will be given to the patient flap will be reflected to expose the facial wall of the maxilla then The ascending ramus is accessed. A disc bur will be used to make a rectangular osteotomy The block bone graft is removed from ascending ramus to recipient site the fixed by mini screws Doner site flap is closed by using interrupted internal sutures. after atrophic maxillary alveolar ridge augmentation,sub mucosal periosteal releasing cuts is done Post-operative medications will be prescribed as follows: amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, metronidazole 5 mg/kg every 8 hours for 7 days
Local anesthesia will be given to the patient flap will be reflected to expose the facial wall of the maxilla then The chin is accessed. A disc bur will be used to make a rectangular osteotomy The block bone graft is removed from chin to recipient site the fixed by mini screws Doner site flap is closed by using interrupted internal sutures after atrophic maxillary alveolar ridge augmentation,submucosal periosteal releasing cuts is done Post-operative medications will be prescribed as follows: amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, metronidazole 5 mg/kg every 8 hours for 7days
Outcomes
Primary Outcome Measures
width and height of the bone gained by the procedure and the new measures from a physiologic vital structures e.g( nasal floor, maxillary sinus or even occlusal plan)
new bone formation
Secondary Outcome Measures
Histomorphometric analysis bone area percent
Nature and quality of new bone histology
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03629860
Brief Title
Ascending Ramus Versus Chin Cortical Plates for Reconstruction of Atrophic Maxilla
Official Title
Assessment of Mandibular Ascending Ramus Cortical Plates for Reconstruction of Atrophic Maxillary Ridges Versus Chin Cortical Plates(Randomized Clinical Tial)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
February 8, 2019 (Anticipated)
Study Completion Date
April 9, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)
Detailed Description
Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial) To know what is better and more efficient chin or ascending ramus cortical plates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy of Edentulous Maxillary Alveolar Ridge
Keywords
Atrophic, augmetation, bone regeneration
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)
Masking
Participant
Masking Description
Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ascending ramus group
Arm Type
Active Comparator
Arm Description
Local anesthesia will be given to the patient
flap will be reflected to expose the facial wall of the maxilla then The ascending ramus is accessed.
A disc bur will be used to make a rectangular osteotomy
The block bone graft is removed from ascending ramus to recipient site the fixed by mini screws
Doner site flap is closed by using interrupted internal sutures.
after atrophic maxillary alveolar ridge augmentation,sub mucosal periosteal releasing cuts is done
Post-operative medications will be prescribed as follows: amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, metronidazole 5 mg/kg every 8 hours for 7 days
Arm Title
Chin Group
Arm Type
Active Comparator
Arm Description
Local anesthesia will be given to the patient
flap will be reflected to expose the facial wall of the maxilla then The chin is accessed.
A disc bur will be used to make a rectangular osteotomy
The block bone graft is removed from chin to recipient site the fixed by mini screws
Doner site flap is closed by using interrupted internal sutures
after atrophic maxillary alveolar ridge augmentation,submucosal periosteal releasing cuts is done
Post-operative medications will be prescribed as follows: amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, metronidazole 5 mg/kg every 8 hours for 7days
Intervention Type
Procedure
Intervention Name(s)
Atrophic maxillary alveolar ridge augmentation
Intervention Description
Autogenous bone blocks from chin and ascending ramus are obtained and used for reconstruction of atrophic maxillary ridges
Primary Outcome Measure Information:
Title
width and height of the bone gained by the procedure and the new measures from a physiologic vital structures e.g( nasal floor, maxillary sinus or even occlusal plan)
Description
new bone formation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Histomorphometric analysis bone area percent
Description
Nature and quality of new bone histology
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with atrophic maxilla with residual bone height from 3 to 4mm.
Both sexes
Exclusion Criteria:
Intraoral soft and hard tissue pathology.
Systemic condition that contraindicate implant basement.
Psychiatric problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Y Zayed, BSD
Phone
00201111634311
Ext
00201140425144
Email
ahmed.zayed@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Y Usry, BSD
Phone
00201140425144
Ext
00201140425144
Email
ahmed.zayed.imlantology@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Y Yousri, Bsd
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
State/Province
Al-Manial
ZIP/Postal Code
11553
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Y Zayed, BSD
Phone
01111634311
Email
ahmed.zayed@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Ahmed Y Usry, BSD
Phone
01140425144
Email
ahmed.zayed.implantology@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Websites and papers
Citations:
PubMed Identifier
25183902
Citation
Ali SA, Karthigeyan S, Deivanai M, Kumar A. Implant rehabilitation for atrophic maxilla: a review. J Indian Prosthodont Soc. 2014 Sep;14(3):196-207. doi: 10.1007/s13191-014-0360-4. Epub 2014 Apr 22.
Results Reference
background
PubMed Identifier
15800467
Citation
Sorni M, Guarinos J, Garcia O, Penarrocha M. Implant rehabilitation of the atrophic upper jaw: a review of the literature since 1999. Med Oral Patol Oral Cir Bucal. 2005 Apr 1;10 Suppl 1:E45-56. English, Spanish.
Results Reference
background
PubMed Identifier
22117951
Citation
Dym H, Huang D, Stern A. Alveolar bone grafting and reconstruction procedures prior to implant placement. Dent Clin North Am. 2012 Jan;56(1):209-18, x. doi: 10.1016/j.cden.2011.09.005.
Results Reference
background
PubMed Identifier
19418861
Citation
Bellini CM, Romeo D, Galbusera F, Agliardi E, Pietrabissa R, Zampelis A, Francetti L. A finite element analysis of tilted versus nontilted implant configurations in the edentulous maxilla. Int J Prosthodont. 2009 Mar-Apr;22(2):155-7.
Results Reference
background
PubMed Identifier
23522364
Citation
Bidra AS, Almas K. Mini implants for definitive prosthodontic treatment: a systematic review. J Prosthet Dent. 2013 Mar;109(3):156-64. doi: 10.1016/S0022-3913(13)60035-9.
Results Reference
background
PubMed Identifier
16104964
Citation
Chiriac G, Herten M, Schwarz F, Rothamel D, Becker J. Autogenous bone chips: influence of a new piezoelectric device (Piezosurgery) on chip morphology, cell viability and differentiation. J Clin Periodontol. 2005 Sep;32(9):994-9. doi: 10.1111/j.1600-051X.2005.00809.x.
Results Reference
background
PubMed Identifier
7000788
Citation
Enneking WF, Eady JL, Burchardt H. Autogenous cortical bone grafts in the reconstruction of segmental skeletal defects. J Bone Joint Surg Am. 1980 Oct;62(7):1039-58.
Results Reference
background
PubMed Identifier
22851285
Citation
Menini M, Signori A, Tealdo T, Bevilacqua M, Pera F, Ravera G, Pera P. Tilted implants in the immediate loading rehabilitation of the maxilla: a systematic review. J Dent Res. 2012 Sep;91(9):821-7. doi: 10.1177/0022034512455802. Epub 2012 Jul 31.
Results Reference
background
PubMed Identifier
10453671
Citation
Peleg M, Mazor Z, Garg AK. Augmentation grafting of the maxillary sinus and simultaneous implant placement in patients with 3 to 5 mm of residual alveolar bone height. Int J Oral Maxillofac Implants. 1999 Jul-Aug;14(4):549-56.
Results Reference
background
PubMed Identifier
20595216
Citation
Topolovec-Vranic J, Canzian S, Innis J, Pollmann-Mudryj MA, McFarlan AW, Baker AJ. Patient satisfaction and documentation of pain assessments and management after implementing the adult nonverbal pain scale. Am J Crit Care. 2010 Jul;19(4):345-54; quiz 355. doi: 10.4037/ajcc2010247.
Results Reference
background
Learn more about this trial
Ascending Ramus Versus Chin Cortical Plates for Reconstruction of Atrophic Maxilla
We'll reach out to this number within 24 hrs