- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05720143
Evaluation of Dental Implants After Using Several Bone Splitting Techniques
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).
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Damascus, Syria
- University of Damascus
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Osseodensification group:
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
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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.
|
|
Experimental: Magnetic mallet group:
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: 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.
|
|
Experimental: Piezo-surgery group
Ridge splitting and expansion were performed with piezosurgery inserts, followed by bone expanders
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The marginal bone loss
Time Frame: Assessments will be conducted 4 months after surgery and 6 months after functional loading.
|
Changes in bone height following ridge splitting and expansion were assessed radiographically.
Measurements were performed using cone beam computed tomography (CBCT) and periapical radiography
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Assessments will be conducted 4 months after surgery and 6 months after functional loading.
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The bone width gain radiographically
Time Frame: At baseline, after surgery, 4 months after surgery, and 6 months after functional loading.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant stability quotients (ISQ)
Time Frame: Measurements will be taken at the time of surgery and again 4 months postoperatively.
|
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.
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Measurements will be taken at the time of surgery and again 4 months postoperatively.
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Insertion Torque
Time Frame: During the surgical procedure.
|
The implant insertion torque was measured during implant placement using a dental implant torque wrench and recorded in Newton-centimeters (N·cm).
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During the surgical procedure.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmad Albassal, MSc, Department of Oral and Maxillofacial Surgery, University of Damascus Faculty of Dentistry, Damascus
- Study Director: 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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDDS-OMFS-01-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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