Evaluation of Dental Implants After Using Several Bone Splitting Techniques

NCT05720143 | Completed DMC

• 1 other identifier: UDDS-OMFS-01-2023
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

In both complete and partial tooth loss, the use of dental implants as artificial replacements for missing teeth is a well-established and effective treatment modality, leading to high patient satisfaction and improved quality of life (1). Horizontal deficiencies of the alveolar ridge can hinder implant-supported rehabilitation due to insufficient bone volume to support implant dimensions, negatively affecting the final prosthetic outcome from both functional and esthetic perspectives (2). The split-crest technique reduces treatment time, the number of required surgical procedures, and the risk of complications, making it more acceptable to patients. Additionally, it allows for dental implant placement during the same surgical procedure and eliminates the need for a donor site for graft harvesting (3). In this study, patients with posterior tooth loss in a narrow mandibular ridge underwent dental implant rehabilitation following alveolar ridge splitting and expansion performed using osseodensification, piezosurgery, or a magnetic mallet.

Conditions

Jaw, Edentulous

Keywords

Osseodensification; Piezosurgery; Magnetic mallet

Outcome Measures

Primary Outcomes (2)

• The marginal bone loss

  Changes in bone height following ridge splitting and expansion were assessed radiographically. Measurements were performed using cone beam computed tomography (CBCT) and periapical radiography

  Assessments will be conducted 4 months after surgery and 6 months after functional loading.

• The bone width gain radiographically

  The extent of bony expansion represents the increase in alveolar ridge width in the buccolingual direction, as determined by radiographic assessment using CBCT.

  At baseline, after surgery, 4 months after surgery, and 6 months after functional loading.

Secondary Outcomes (2)

• Implant stability quotients (ISQ)

  Measurements will be taken at the time of surgery and again 4 months postoperatively.

• Insertion Torque

  During the surgical procedure.

Study Arms (3)

Osseodensification group:

EXPERIMENTAL

Ridge splitting and expansion were carried out by creating horizontal and vertical cuts with piezosurgery, followed by expansion of the alveolar ridge using osseodensification burs

Procedure: Osseodensification

Magnetic mallet group:

EXPERIMENTAL

Ridge splitting and expansion were performed using piezosurgery to create horizontal and vertical cuts, followed by chisels with a magnetic mallet to expand the ridge

Procedure: Magnetic mallet

Piezo-surgery group

EXPERIMENTAL

Ridge splitting and expansion were performed with piezosurgery inserts, followed by bone expanders

Procedure: Piezo-surgery

Interventions

Osseodensification PROCEDURE

Procedure: Two horizontal and one vertical osteotomies will be performed using piezosurgery, followed by ridge expansion with osseodensification burs. Immediate implant placement will then be performed.

Osseodensification group:

Magnetic mallet PROCEDURE

Procedure: Two horizontal and one vertical osteotomies will be performed using piezosurgery, followed by ridge expansion using chisels with a magnetic mallet. Immediate implant placement will then be performed.

Magnetic mallet group:

Piezo-surgery PROCEDURE

Two horizontal and one vertical osteotomies will be performed using piezosurgery, followed by ridge expansion using piezosurgery inserts and bone expanders. Immediate implant placement will then be performed.

Piezo-surgery group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients able to attend follow-up appointments.
• Alveolar ridges with sufficient height for the placement of a standard dental implant.
• Presence of spongy bone with at least 1 mm of width between the cortical plates.
• Absence of systemic or local conditions that could affect bone metabolism.

You may not qualify if:

• Severe concavity on the vestibular or palatal side of the alveolar ridge.
• Uncontrolled periodontal disease.
• History of radiotherapy in the head and neck region.
• Smokers or patients with parafunctional habits.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (5)

• Pozzi A, Mura P. Immediate Loading of Conical Connection Implants: Up-to-2-Year Retrospective Clinical and Radiologic Study. Int J Oral Maxillofac Implants. 2016 Jan-Feb;31(1):142-52. doi: 10.11607/jomi.4061.

  PMID: 26800171 BACKGROUND

• Chiapasco M, Zaniboni M, Boisco M. Augmentation procedures for the rehabilitation of deficient edentulous ridges with oral implants. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:136-59. doi: 10.1111/j.1600-0501.2006.01357.x.

  PMID: 16968389 BACKGROUND

• Bassetti MA, Bassetti RG, Bosshardt DD. The alveolar ridge splitting/expansion technique: a systematic review. Clin Oral Implants Res. 2016 Mar;27(3):310-24. doi: 10.1111/clr.12537. Epub 2015 Jan 14.

  PMID: 25586966 BACKGROUND

• Buser D, Mericske-Stern R, Bernard JP, Behneke A, Behneke N, Hirt HP, Belser UC, Lang NP. Long-term evaluation of non-submerged ITI implants. Part 1: 8-year life table analysis of a prospective multi-center study with 2359 implants. Clin Oral Implants Res. 1997 Jun;8(3):161-72. doi: 10.1034/j.1600-0501.1997.080302.x.

  PMID: 9586460 BACKGROUND

• Cochran DL, Buser D, ten Bruggenkate CM, Weingart D, Taylor TM, Bernard JP, Peters F, Simpson JP. The use of reduced healing times on ITI implants with a sandblasted and acid-etched (SLA) surface: early results from clinical trials on ITI SLA implants. Clin Oral Implants Res. 2002 Apr;13(2):144-53. doi: 10.1034/j.1600-0501.2002.130204.x.

  PMID: 11952734 BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous

Interventions

Piezosurgery

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ahmad Albassal, MSc

  Department of Oral and Maxillofacial Surgery, University of Damascus Faculty of Dentistry, Damascus

  PRINCIPAL INVESTIGATOR

• Munir Harfouch, MSc PhD

  Department of Oral and Maxillofacial Surgery, University of Damascus Faculty of Dentistry, Damascus

  STUDY DIRECTOR

• Mazen Zenati, MSc PhD

  Department of Oral and Maxillofacial Surgery, University of Damascus Faculty of Dentistry, Damascus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinding Participant and Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 9, 2023
• Study Start: January 25, 2023
• Primary Completion: February 28, 2025
• Study Completion: June 28, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)