Ascending Ramus Versus Chin Cortical Plates for Reconstruction of Atrophic Maxilla
Assessment of Mandibular Ascending Ramus Cortical Plates for Reconstruction of Atrophic Maxillary Ridges Versus Chin Cortical Plates(Randomized Clinical Tial)
1 other identifier
interventional
12
1 country
1
Brief Summary
Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2019
CompletedAugust 14, 2018
August 1, 2018
9 months
August 6, 2018
August 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months
Secondary Outcomes (1)
Histomorphometric analysis bone area percent
6 months
Study Arms (2)
ascending ramus group
ACTIVE COMPARATOR* 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
Chin Group
ACTIVE COMPARATOR* 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
Interventions
Autogenous bone blocks from chin and ascending ramus are obtained and used for reconstruction of atrophic maxillary ridges
Eligibility Criteria
You may qualify if:
- Patients with atrophic maxilla with residual bone height from 3 to 4mm.
- Both sexes
You may not qualify if:
- Intraoral soft and hard tissue pathology.
- Systemic condition that contraindicate implant basement.
- Psychiatric problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry, Cairo University
Cairo, Al-Manial, 11553, Egypt
Related Publications (10)
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.
PMID: 25183902BACKGROUNDSorni 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.
PMID: 15800467BACKGROUNDDym 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.
PMID: 22117951BACKGROUNDBellini 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.
PMID: 19418861BACKGROUNDBidra 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.
PMID: 23522364BACKGROUNDChiriac 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.
PMID: 16104964BACKGROUNDEnneking 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.
PMID: 7000788BACKGROUNDMenini 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.
PMID: 22851285BACKGROUNDPeleg 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.
PMID: 10453671BACKGROUNDTopolovec-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.
PMID: 20595216BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Y Yousri, Bsd
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- B.D.S,Principal investigator,dentist
Study Record Dates
First Submitted
August 6, 2018
First Posted
August 14, 2018
Study Start
May 1, 2018
Primary Completion
February 8, 2019
Study Completion
April 9, 2019
Last Updated
August 14, 2018
Record last verified: 2018-08