One Stage Ridge Splitting Using 2 Different Techniques in Maxilla

NCT06891261 | Recruiting

• 1 other identifier: 00-0001-6142-0568
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

• The selected patients will be informed of the nature of the research work and informed consent will be obtained.
• Patients of both groups will be subjected to CBCT.
• Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months.
• Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine) Both the study and control group will receive:
• In Recipient site, full thickness mucoperiosteal flap pyramidal flap, reflection using mucoperiosteal elevator.
• The defective site is reevaluated.
• Flap advancement inorder to allow tension free flap closure.
• In the Study group: Piezo surgery bone inserts is used to cut crestal osteotomies.
• In the Control group: Bone discs diameter is used.
• Followed by, the use of bone chisels.
• The point and pilot implant drills are used followed by bone expanders. Based on the preexisting bone, the defect morphology and bone quality. The implant is submerged below the alveolar crest to compensate for crestal bone resorption.
• Following partial immobilization of the buccal bone segment either book or island pattern. The fixture is inserted submerged below the alveolar bone crest. Followed by bone smoothening and roundation under external saline irrigation at recommended speed of 38000rpm and gear ratio 1:1 calibrated on fesiodespenser.
• Xenogenic bone particle size of 0.5 mm to 1mm is going to be condensed into the dead space.
• Recheck adequate flap advancement to allow tension free closure.
• Double line closure using horizontal mattress followed by interrupted sutures to allow contact area and wound edge eversion.

Conditions

Ridge Augmentation; Bone Augmentation

Keywords

ridge augmentation; One stage ridge splitting in maxilla.; Piezo Surgery

Outcome Measures

Primary Outcomes (1)

• Bone Quality of bone gain.

  Measured using linear measurements from CBCT in millimeters.

  At 4 months from ridge augmentation.

Secondary Outcomes (1)

• Soft Tissue Dehiscence.

  Baseline 1st Week.

Study Arms (2)

Study Group A: Piezo Surgery.

ACTIVE COMPARATOR

Straight and angled bone inserts were utilized.

Device: Piezo Surgery.

Control Group B: Conventional Technique.

ACTIVE COMPARATOR

using bone discs of 7mm diameter mounted on contra angled 1:1 and 6.5mm diameter bone discs mounted on 1:1 external irrigation straight hand piece.

Procedure: Bone Discs.

Interventions

Piezo Surgery. DEVICE

Piezotome woodpecker®: Surgic touch.

Study Group A: Piezo Surgery.

Bone Discs. PROCEDURE

bone discs mounted on staight hand piece and contra angled 1:1 gear ratio.

Control Group B: Conventional Technique.

Eligibility Criteria

• Age: 20 Years - 48 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with maxilla residual alveolar bone height not less than 8 mm.
• Alveolar bone width from 5mm to 3mm.
• Both genders.
• At least single missing tooth.
• Previous failed implants.
• Tapered or cylinder cross sectioned alveolar bone defect pattern.

You may not qualify if:

• Heavy smokers more than 20 cigarettes per day.
• Patients with bone disease that may affect normal healing, example; hyperparathyroidism.
• Patients had radiotherapy and chemotherapy in head and neck.
• Patients had neoplasms in sites to be grafted.
• Patients with Metabolic diseases uncontrolled diabetic patients, Glycated hemoglobin (Hb A1c) more than 7 mg\\dl.
• Pregnant females.
• Patients with Para functional habits, apprehensive and non-cooperative.
• Bone pathology related to the site to be grafted.
• Psychological problems, stress situation (socially or professionally), emotional instability, and unrealistic patients' expectations.
• Intraoral soft and hard tissue pathology.
• Systemic condition that contraindicates implant placement.
• Under the age of 18 years.
• Hourglass defects or defects with bone concavities and or undercuts.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, 11553, Egypt

RECRUITING

Related Publications (9)

• Spin-Neto R, Landazuri Del Barrio RA, Pereira LA, Marcantonio RA, Marcantonio E, Marcantonio E Jr. Clinical similarities and histological diversity comparing fresh frozen onlay bone blocks allografts and autografts in human maxillary reconstruction. Clin Implant Dent Relat Res. 2013 Aug;15(4):490-7. doi: 10.1111/j.1708-8208.2011.00382.x. Epub 2011 Aug 11.

  PMID: 21834864 BACKGROUND

• Acocella A, Bertolai R, Ellis E 3rd, Nissan J, Sacco R. Maxillary alveolar ridge reconstruction with monocortical fresh-frozen bone blocks: a clinical, histological and histomorphometric study. J Craniomaxillofac Surg. 2012 Sep;40(6):525-33. doi: 10.1016/j.jcms.2011.09.004. Epub 2011 Nov 9.

  PMID: 22075326 BACKGROUND

• Dasmah A, Thor A, Ekestubbe A, Sennerby L, Rasmusson L. Particulate vs. block bone grafts: three-dimensional changes in graft volume after reconstruction of the atrophic maxilla, a 2-year radiographic follow-up. J Craniomaxillofac Surg. 2012 Dec;40(8):654-9. doi: 10.1016/j.jcms.2011.10.032. Epub 2011 Dec 3.

  PMID: 22137760 BACKGROUND

• AlGhamdi AS. Post-surgical complications of symphyseal block graft with and without soft tissue grafting. Saudi Med J. 2013 Jun;34(6):609-15.

  PMID: 23756926 BACKGROUND

• Monje A, Monje F, Chan HL, Suarez F, Villanueva-Alcojol L, Garcia-Nogales A, Wang HL. Comparison of microstructures between block grafts from the mandibular ramus and calvarium for horizontal bone augmentation of the maxilla: a case series study. Int J Periodontics Restorative Dent. 2013 Nov-Dec;33(6):e153-61. doi: 10.11607/prd.1664.

  PMID: 24116370 BACKGROUND

• Aloy-Prosper A, Penarrocha-Oltra D, Penarrocha-Diago M, Penarrocha-Diago M. The outcome of intraoral onlay block bone grafts on alveolar ridge augmentations: a systematic review. Med Oral Patol Oral Cir Bucal. 2015 Mar 1;20(2):e251-8. doi: 10.4317/medoral.20194.

  PMID: 25662543 BACKGROUND

• Reininger D, Cobo-Vazquez C, Monteserin-Matesanz M, Lopez-Quiles J. Complications in the use of the mandibular body, ramus and symphysis as donor sites in bone graft surgery. A systematic review. Med Oral Patol Oral Cir Bucal. 2016 Mar 1;21(2):e241-9. doi: 10.4317/medoral.20938.

  PMID: 26827063 BACKGROUND

• Khoury F: Augmentation of severe bony defects with intraoral bone grafts: biological approach and long-term results J Oral Maxillo Fac Surg 2017Volume 46, Supplement 1, Pages 26-27.

  BACKGROUND

• Claudino M, Julio C L, Luis E M, Bernardo M, Fernando G, tomographic evaluation of atrophic maxilla rehabilitated with autogenous and xenogeneic block grafts. Journal of Research in Dentistry 2017, 4(4):112-117.

  BACKGROUND

MeSH Terms

Interventions

Piezosurgery

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Mohannad A. Ismail, MSc.

CONTACT

01222968444; mohannadahmed@hotmail.com

Ahmed M Youssef, PhD

CONTACT

01067941236; Ahmed.Youssef@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The patients were randomly allocated into two groups utilizing Random Allocation Software version 2.0. then the allocation was concealed in opaque sealed envelopes. In the study group (A) Piezo Surgery inserts are going to be used to create alveolar bone osteotomies, while in the control group (B) bone discs are used. All procedures were performed by one surgeon in both groups, the allocation was revealed to the operator just before the surgery. On the other hand, the patients, outcome assessor and the statistician who analyzed the collected data and performed the statistical analysis were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: March 24, 2025
• Study Start: February 26, 2025
• Primary Completion: July 30, 2025
• Study Completion: October 31, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)