Effect of Osseodensification on the Peri-implant Condition

Evaluation of the Effect of Osseodensification on the Peri-implant Condition

The goal of this clinical trial is to evaluate the effects of osseodensification vs. traditional implant site preparation clinically , radiographically, bio-chemically. in patients of both sexes, ages 25 to 45, who had bilaterally missed maxillary teeth. The main questions it aims to answer are :which technique was the better results give at implant placement? Researchers will compare Osseodensification maneuver in implant placement to see if implant stability increased also peri-implant tissue accurately formed or the same in traditional implant site preparation. Participants will receiving dental implants in narrow maxillary posterior ridge via small diameter implant in conventional method in first entity while in second entity implant by osseodensification technique using densah bur.

Study Overview

• Status: Completed
• Conditions: Implant Therapy
• Intervention / Treatment: Procedure: conventional implant placement method; Procedure: Osseodensification to implant placement using densah bur kit

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71524
    • Faculty of dental medicine, Al-Azhar University (Assiut branch)

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• All patients were free from any systemic diseases
• Individuals above age of 18 who have thin ridges and missing bilateral maxillary posterior teeth

Exclusion Criteria:

• Severe skeletal discrepancy.
• Para functional habits.
• Patients who had already received or lost implants in the potential implantation site.
• Smoker patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: patients with narrow ridge received small diameter implant in conventional method.	Procedure: conventional implant placement method; Site marking was the first step in preparing the place for implantation. Subsequently, using a high speed surgical handpiece and a surgical motor, a pilot drill was revolved at 1200 RPM in a clockwise rotation to the desired depth, creating a 1.5 mm first pilot osteotomy. An X-ray was obtained using paralleling pins to validate the angle between the surrounding teeth and the implants. Eventually the implant's precise placement was established. To prepare the osteotomy site to the desired diameter, drills are used sequentially at 1200 RPM in a clockwise motion. Gradually bigger drill diameters were used for incremental drilling. Based on the diameter of the desired implant, bur sizes were utilized in ascending order
Active Comparator: patients with narrow ridge received implant by OD technique using densah bur.	Procedure: Osseodensification to implant placement using densah bur kit; Beginning with site marking, the area was prepared for implantation. A high speed surgical handpiece and a surgical motor (surgic pro® NSK, Japan) were then used to construct a 1.5 mm initial pilot osteotomy using a pilot drill spun at 1200 RPM in a clockwise rotation to the desired depth. In order to verify the angle between the surrounding teeth and the implants, paralleling pins were used to capture an X-ray. After it was determined that the implant was in the proper location, OD was used to extend the osteotomy using a Densah® Bur VT1525 2.0-mm (VersahTM, LLC, USA) in non-cutting anticlockwise rotation at 1200 RPM (Densifying Mode). The osteotomy was expanded to the desired diameter by repeatedly using a DensahTM Bur operating in a non-cutting anticlockwise (CCW) direction at 1200 RPM (Densifying Mode). Gradually increasing drill diameters were used for incremental drilling. Based on the diameter of the desired implant, bur sizes (diameters) were utilised in ascending order

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant primary stability	Osstell® Mentor magnetic resonance instrument used to measure primary stability	A single time point (once immediately after implant placement)
Bone density	Measuring of bone density (BD) through using the image J analysis software application	From enrollment to the end of treatment at 24 weeks" (at the beginning, one, three-, and six-months following implant insertion)
Assessment of interleukin -6		From enrollment to the end of treatment at 24 weeks" (at the beginning, one, three-, and six-months following implant insertion)
Assessment of Vascular endothelial growth factor		[Time Frame: From enrollment to the end of treatment at 24 weeks" (at the beginning, one, three-, and six-months following implant insertion)]

Secondary Outcome Measures

Outcome Measure	Time Frame
Peri-implant probing depth	From enrollment to the end of treatment at 24 weeks" (at the beginning, three-, and six-months following implant insertion)

Collaborators and Investigators

• Sponsor: Al-Azhar University

Publications and helpful links

General Publications

• Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep. Implant Dent. 2016 Feb;25(1):24-31. doi: 10.1097/ID.0000000000000358.
• Strietzel FP, Nowak M, Kuchler I, Friedmann A. Peri-implant alveolar bone loss with respect to bone quality after use of the osteotome technique: results of a retrospective study. Clin Oral Implants Res. 2002 Oct;13(5):508-13. doi: 10.1034/j.1600-0501.2002.130510.x.
• Johnson RB, Serio FG, Dai X. Vascular endothelial growth factors and progression of periodontal diseases. J Periodontol. 1999 Aug;70(8):848-52. doi: 10.1902/jop.1999.70.8.848.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): October 29, 2023
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Osseodensification
• Other Study ID Numbers: Osseodensification in implant

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No