NCT07586475

Brief Summary

This clinical study evaluates and compares the primary stability of dental implants placed using osseodensification with Densah burs versus conventional drilling methods. The goal is to determine whether osseodensification improves implant stability and bone density, especially in areas with low bone quality

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Dec 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

Same day

First QC Date

January 20, 2026

Last Update Submit

May 7, 2026

Conditions

Keywords

dental impantprimary stabilityossseodensficationdensah bursconventional osteotomy

Outcome Measures

Primary Outcomes (1)

  • Primary Implant Stability Measured by Implant Stability Quotient (ISQ) Using the Osstell Device

    Description: Primary implant stability will be assessed immediately after implant placement using the Implant Stability Quotient (ISQ) obtained from the Osstell device. The ISQ scale ranges from 1 to 100, with higher values indicating greater implant stability.

    Immediately after implant placement (within minutes)

Study Arms (2)

controlled group conventional drilling group

ACTIVE COMPARATOR

Participants in this group will receive dental implants using the traditional drilling technique, which removes bone to create space for the implant.

Procedure: convetional Driiling technique

study group of osseodensification Group

EXPERIMENTAL

Participants in this group will receive dental implants using the osseodensification technique with Densah burs, which preserves and compacts bone to enhance primary stability.

Procedure: osseodensification using densah burs

Interventions

Participants will be divided into two groups. The first group will undergo implant site preparation using the osseodensification technique with Densah burs, which compacts bone and enhances primary stability without removing bone. The second group will undergo conventional drilling, where bone is removed in a stepwise manner to prepare the implant site according to standard surgical protocols."

study group of osseodensification Group

"This group will receive implant site preparation using the conventional drilling technique, where bone is gradually removed to create space for the implant, as per standard implantology protocols."

controlled group conventional drilling group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients
  • Patients requiring dental implant placement in areas with varying bone quality
  • Patients without systemic diseases that interfere with bone healing or implant success (e.g., uncontrolled diabetes mellitus or osteoporosis)

You may not qualify if:

  • Patients with systemic diseases affecting bone metabolism
  • Presence of large periapical radiographic lesions related to the tooth to be extracted (abscess, granuloma, or cyst)
  • Teeth requiring transalveolar extraction
  • Patients with contraindications to surgical treatment
  • Patients with psychological disorders
  • Patients with uncontrolled medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

May 14, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

May 14, 2026

Record last verified: 2026-05