Osseodensification in Enhancing Implant Stability and Ridge Expansion in Esthetic Region

Effectiveness of Osseodensification in Enhancing Implant Stability and Ridge Expansion in Esthetic Region (a Randomized Controlled Clinical Trial)

Dental implants supported restorations have been widely accepted as one of the treatment modalities to replace missing teeth and to restore human masticatory function. Successful osseointegration from the clinical standpoint is a measured by implant stability, which occurs after implant integration. Osseodensification is a bio-mechanical site preparation technique. It utilizes a multi-fluted densifying bur technology that creates and expands a pilot hole without excavating significant amounts of bone tissue through a unique, highly controllable, fast, and efficient procedure with minimal heat elevation.

Aim of the study: Is to evaluate and compare the efficacy of using osseodensification compared to conventional bone expansion in implant stability and ridge expansion.

Study Overview

• Status: Completed
• Conditions: Dental Implant; Bone Expantion
• Intervention / Treatment: Device: Osseodesification densah burs; Device: Microdent

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Missing maxillary anterior tooth, having moderate horizontal ridge defect in which the alveolar ridge width is( 3-4) mm, and its height is not less than 10 mm.
• Presence of adequate keratinized mucosa.
• Patients with good oral hygiene.
• Patients are free from any systemic diseases that might affect healing.
• Presence of adequate inter-occlusal and mesiodistal space that permits placement of fixed prosthesis.

Exclusion Criteria:

• Heavy smokers and bad oral hygiene patients.
• Medically compromised patients that affecting placement of implant.
• Alcohol or drug abuse.
• Pregnant women.
• Patients suffering from osteoporosis.
• Current chemotherapy or radiotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Device: Microdent; No. 1 Microdent expander will be placed and screwed slowely (to avoid heat generation) into the osteotomy site till reaching the full desired length. N0. 2 microdent expander will be placed and screwed into the osteotomy site as the same step. Then no. 3 Microdent expander will be inserted for placing 3.5mm implant diameter; Other Names: Conventional manual bone expanders
Experimental: Study group	Device: Osseodesification densah burs; Drill no. VT1525 (2mm) of densah burs will be used first in counter clockwise (in the osteotomy site). Then drill no. VT2535 (3mm) of densah burs will be used in counter clockwise to put 3.5mm implant diameter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in implant stability	Implant stability will be measured using the Ostell device.	Baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bone density	The patients will be examined radiographically using CBCT	Baseline and 16 weeks
Change in ridge expansion	The patients will be examined radiographically using CBCT	Baseline and 16 weeks
Change in bone loss	The patients will be examined radiographically using CBCT	Baseline and 16 weeks

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Actual): September 28, 2021
• Study Completion (Actual): September 28, 2021

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 0105-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No