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Jaw, EdentulousNCT05720143

Evaluation of Dental Implants After Using Several Bone Splitting Techniques

A study testing Osseodensification, Magnetic mallet and Piezo-surgery in people with Jaw, Edentulous, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Jaw, Edentulous
What is being tested?
Osseodensification, Magnetic mallet and Piezo-surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteSyria
Study dates
25 Jan 2023to 28 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • University of Damascus

    Damascus

Other trials in Syria

About this study

Official title: Evaluation of Clinical and Radiographic Outcomes of Immediate Dental Implants After Using Three Bone Splitting Techniques in Narrow Mandibular Alveolar Ridges: A Randomized Controlled Clinical Study

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).

Read more

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.

Read the detailed description

The objective of this study is to compare ridge width gain following ridge splitting and expansion with simultaneous implant placement using osseodensification, piezosurgery, or a magnetic mallet in individuals with narrow mandibular alveolar ridges.

Thirty-nine patients will be randomly allocated into three groups. In Group 1, ridge splitting and expansion will be performed using piezosurgery and bone expanders, followed by simultaneous implant placement.

In Group 2, osseodensification burs will be used after ridge splitting, with simultaneous implant placement.

In Group 3, a magnetic mallet will be used after ridge splitting, with simultaneous implant placement.

Conditions
Jaw, Edentulous
Being tested
Osseodensification, Magnetic mallet, Piezo-surgery
Keywords
Osseodensification, Piezosurgery, Magnetic mallet
Medical subject headings
Jaw, Edentulous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OsseodensificationProcedure or surgery

    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.

  • Magnetic malletProcedure or surgery

    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.

  • Piezo-surgeryProcedure or surgery

    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.

Study groups in NCT05720143
Study groupRoleWhat they receive
Osseodensification group:ExperimentalRidge splitting and expansion were carried out by creating horizontal and vertical cuts with piezosurgery, followed by expansion of the alveolar ridge using osseodensification burs
Receives: Procedure: Osseodensification
Magnetic mallet group:ExperimentalRidge splitting and expansion were performed using piezosurgery to create horizontal and vertical cuts, followed by chisels with a magnetic mallet to expand the ridge
Receives: Procedure: Magnetic mallet
Piezo-surgery groupExperimentalRidge splitting and expansion were performed with piezosurgery inserts, followed by bone expanders
Receives: Procedure: Piezo-surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

Secondary outcomes (2)

  1. Implant stability quotients (ISQ)

    The Implant Stability Quotient (ISQ), measured using the MEGA device, provides a numerical assessment of both primary and secondary stability of dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability and a higher likelihood of successful osseointegration.

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

  2. Insertion Torque

    The implant insertion torque was measured during implant placement using a dental implant torque wrench and recorded in Newton-centimeters (N·cm).

    Measured: During the surgical procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2023
  2. Study start25 Jan 2023
  3. Primary completion28 Feb 2025
  4. Study completion28 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05720143
Sponsor's protocol ID
UDDS-OMFS-01-2023
Status last verified
Jan 2026
First submitted
28 Jan 2023
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26800171

  • 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.

    PubMed 16968389

  • 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.

    PubMed 25586966

  • 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.

    PubMed 9586460

  • 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.

    PubMed 11952734

Questions about this trial

What is this clinical trial studying?

A study testing Osseodensification, Magnetic mallet and Piezo-surgery in people with Jaw, Edentulous, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The marginal bone loss (time frame: Assessments will be conducted 4 months after surgery and 6 months after functional loading.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05720143, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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