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)

Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)

Study Overview

• Status: Unknown
• Conditions: Atrophy of Edentulous Maxillary Alveolar Ridge
• Intervention / Treatment: Procedure: Atrophic maxillary alveolar ridge augmentation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al-Manial
    • Cairo, Al-Manial, Egypt, 11553
      • Recruiting
      • Faculty of Dentistry, Cairo University
      • Contact: Ahmed Y Zayed, BSD; Phone Number: 01111634311; Email: ahmed.zayed@dentistry.cu.edu.eg
      • Contact: Ahmed Y Usry, BSD; Phone Number: 01140425144; Email: ahmed.zayed.implantology@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ascending ramus group; 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	Procedure: Atrophic maxillary alveolar ridge augmentation; Autogenous bone blocks from chin and ascending ramus are obtained and used for reconstruction of atrophic maxillary ridges
Active Comparator: Chin Group; 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	Procedure: Atrophic maxillary alveolar ridge augmentation; Autogenous bone blocks from chin and ascending ramus are obtained and used for reconstruction of atrophic maxillary ridges

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histomorphometric analysis bone area percent	Nature and quality of new bone histology	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ahmed Y Yousri, Bsd, Cairo University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): February 8, 2019
• Study Completion (Anticipated): April 9, 2019

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Atrophic, augmetation, bone regeneration
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: Ahmed yousri

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Websites and papers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No