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Completed

NCT Number: NCT06689969

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Asyut, Asyut Governorate, 71524, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conventional implant placement method

Procedure

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 kit

Procedure

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

Primary outcomes

  1. Implant primary stability

    Time frame: A single time point (once immediately after implant placement)

    Osstell® Mentor magnetic resonance instrument used to measure primary stability

  2. Bone density

    Time frame: From 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

  3. Assessment of interleukin -6

    Time frame: From enrollment to the end of treatment at 24 weeks" (at the beginning, one, three-, and six-months following implant insertion)

  4. Assessment of Vascular endothelial growth factor

    Time frame: [Time Frame: From enrollment to the end of treatment at 24 weeks" (at the beginning, one, three-, and six-months following implant insertion)]

Secondary outcomes

  1. Peri-implant probing depth

    Time frame: From enrollment to the end of treatment at 24 weeks" (at the beginning, three-, and six-months following implant insertion)

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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