CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
conventional implant placement method +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06689969
NCT06689969Phase 2Completed

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

Al-Azhar University·interventional·Posted Nov 15, 2024·Updated Nov 15, 2024

In Brief

A Phase 2 clinical trial evaluating conventional implant placement method and Osseodensification to implant placement using densah bur kit for Implant Therapy. Completed, enrolled 16 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImplant Therapy
CountriesEgypt
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedNov 15, 2024
Enrollment StartJan 3, 2022
Primary CompletionOct 29, 2023
Study CompletionMar 15, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 1.6 years ago

Interventions

conventional implant placement methodprocedure

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

Osseodensification to implant placement using densah bur kitprocedure

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