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Clinical Trials/NCT06689969
NCT06689969CompletedPhase 2

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

Al-Azhar University1 site in 1 country16 target enrollmentStarted: January 3, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Bone density

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

patients with narrow ridge received small diameter implant in conventional method.

Active Comparator

Intervention: conventional implant placement method (Procedure)

patients with narrow ridge received implant by OD technique using densah bur.

Active Comparator

Intervention: Osseodensification to implant placement using densah bur kit (Procedure)

Outcomes

Primary Outcomes

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

Implant primary stability

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

Osstell® Mentor magnetic resonance instrument used to measure primary stability

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)]

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)

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Asem Mohammed Kamel Ali

Director

Al-Azhar University

Study Sites (1)

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