One Stage Ridge Splitting Using 2 Different Techniques in the Posterior Mandible

NCT06891313 | Recruiting

• 1 other identifier: 000-0001-6142-0568
• 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. The control group ridge splitting with simultaneous implants using the conventional technique and study group ridge splitting with simultaneous implants using the piezo surgery.

• Pre operative procedures 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, incision of full thickness mucoperiosteal flap inorder to obtain, three-line pyramidal flap, followed by flap reflection.
• The defective site is reevaluated.
• Flap advancement using periosteal releasing incision.
• In the Study group: Piezo surgery bone inserts are used.
• In the Control group: Bone discs diameter are used.
• Followed by bone chisels.
• The point and pilot implant drills are used followed by the sequential use of bone expanders. Based on the preexisting bone, the defect morphology and bone quality. The implant is submerged below the alveolar crest.
• 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.
• Double line closure using horizontal mattress sutures followed by interrupted sutures on top to allow contact area and wound edge eversion.

Conditions

Ridge Augmentation; Bone Augmentation

Keywords

ridge augmentation; One stage ridge splitting in posterior mandible.; Piezo Surgery

Outcome Measures

Primary Outcomes (1)

• Bone Quantity of bone gain.

  Measured using linear measurements from Cone Beam Computed Tomography 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

Piezo surgery bone inserts is used to cut crestal osteotomy in the center of the alveolar bone ridge bucco-lingual traversing the compact bone into the spongiosa Followed by two semi vertical osteotomies at least 1.5mm away from the adjacent teeth.

Device: Piezo Surgery.

Control Group B: Bone Discs.

ACTIVE COMPARATOR

Bone discs diameter 7mm mounted on contra angled 1:1 is used to cut crestal osteotomy in the center of the alveolar bone ridge bucco-lingual traversing the compact bone into the spongiosa, followed by two semi vertical osteotomies at least 1.5mm away from the adjacent teeth using bone discs diameter 6.5mm mounted on external irrigation straight hand piece.

Procedure: Bone Discs

Interventions

Piezo Surgery. DEVICE

Using bone cutting inserts.

Study Group A: Piezo Surgery.

Bone Discs PROCEDURE

Selected bone discs diameters mounted on contra angled hand piece and external irrigation hand piece at gear ratio 1:1.

Control Group B: Bone Discs.

Eligibility Criteria

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

You may qualify if:

• Patients with mandibular 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 (13)

• Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.

  PMID: 18437791 BACKGROUND

• Jensen OT, Bell W, Cottam J. Osteoperiosteal flaps and local osteotomies for alveolar reconstruction. Oral Maxillofac Surg Clin North Am. 2010 Aug;22(3):331-46, vi. doi: 10.1016/j.coms.2010.04.003.

  PMID: 20713266 BACKGROUND

• Bravi F, Bruschi GB, Ferrini F. A 10-year multicenter retrospective clinical study of 1715 implants placed with the edentulous ridge expansion technique. Int J Periodontics Restorative Dent. 2007 Dec;27(6):557-65.

  PMID: 18092450 BACKGROUND

• Tolstunov L, Hamrick JFE, Broumand V, Shilo D, Rachmiel A. Bone Augmentation Techniques for Horizontal and Vertical Alveolar Ridge Deficiency in Oral Implantology. Oral Maxillofac Surg Clin North Am. 2019 May;31(2):163-191. doi: 10.1016/j.coms.2019.01.005.

  PMID: 30947846 BACKGROUND

• Tolstunov L. Classification of the alveolar ridge width: implant-driven treatment considerations for the horizontally deficient alveolar ridges. J Oral Implantol. 2014 Jul;40 Spec No:365-70. doi: 10.1563/aaid-joi-D-14-00023. Epub 2014 Feb 27.

  PMID: 24575743 BACKGROUND

• Hammerle CH, Jung RE. Bone augmentation by means of barrier membranes. Periodontol 2000. 2003;33:36-53. doi: 10.1046/j.0906-6713.2003.03304.x. No abstract available.

  PMID: 12950840 BACKGROUND

• Urban IA, Nagursky H, Lozada JL. Horizontal ridge augmentation with a resorbable membrane and particulated autogenous bone with or without anorganic bovine bone-derived mineral: a prospective case series in 22 patients. Int J Oral Maxillofac Implants. 2011 Mar-Apr;26(2):404-14.

  PMID: 21483894 BACKGROUND

• Urban IA, Nagursky H, Lozada JL, Nagy K. Horizontal ridge augmentation with a collagen membrane and a combination of particulated autogenous bone and anorganic bovine bone-derived mineral: a prospective case series in 25 patients. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):299-307. doi: 10.11607/prd.1407.

  PMID: 23593623 BACKGROUND

• Pellegrino G, Lizio G, Corinaldesi G, Marchetti C. Titanium Mesh Technique in Rehabilitation of Totally Edentulous Atrophic Maxillae: A Retrospective Case Series. J Periodontol. 2016 May;87(5):519-28. doi: 10.1902/jop.2016.150432. Epub 2016 Jan 12.

  PMID: 26759078 BACKGROUND

• Misch CM. Comparison of intraoral donor sites for onlay grafting prior to implant placement. Int J Oral Maxillofac Implants. 1997 Nov-Dec;12(6):767-76.

  PMID: 9425757 BACKGROUND

• Montazem A, Valauri DV, St-Hilaire H, Buchbinder D. The mandibular symphysis as a donor site in maxillofacial bone grafting: a quantitative anatomic study. J Oral Maxillofac Surg. 2000 Dec;58(12):1368-71. doi: 10.1053/joms.2000.18268.

  PMID: 11117684 BACKGROUND

• Clavero J, Lundgren S. Ramus or chin grafts for maxillary sinus inlay and local onlay augmentation: comparison of donor site morbidity and complications. Clin Implant Dent Relat Res. 2003;5(3):154-60. doi: 10.1111/j.1708-8208.2003.tb00197.x.

  PMID: 14575631 BACKGROUND

• Pourabbas R, Nezafati S. Clinical results of localized alveolar ridge augmentation with bone grafts harvested from symphysis in comparison with ramus. J Dent Res Dent Clin Dent Prospects. 2007 Spring;1(1):7-12. doi: 10.5681/joddd.2007.002. Epub 2007 Jun 10.

  PMID: 23277827 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 going to be 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)