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Effect of Osseodensification on the Peri-implant Condition

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06689969
Enrollment
16
Registered
2024-11-15
Start date
2022-01-03
Completion date
2024-03-15
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant Therapy

Keywords

Osseodensification

Brief 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.

Interventions

PROCEDUREconventional 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

PROCEDUREOsseodensification 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

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Implant primary stabilityA single time point (once immediately after implant placement)Osstell® Mentor magnetic resonance instrument used to measure primary stability
Bone densityFrom enrollment to the end of treatment at 24 weeks (at the beginning, one, three-, and six-months following implant insertion)Measuring of bone density (BD) through using the image J analysis software application
Assessment of interleukin -6From 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

MeasureTime frame
Peri-implant probing depthFrom enrollment to the end of treatment at 24 weeks (at the beginning, three-, and six-months following implant insertion)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026