NCT07244185

Brief Summary

The effect of osseodensification versus conventional implant site preparation on implant stability for tapered and cylindrical dental implants.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2026

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 13, 2025

Last Update Submit

November 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • primary stability

    Primary stability refers to the mechanical stability of a dental implant (or any bone implant) immediately after placement, before bone healing or osseointegration occurs. It mainly depends on bone quality and density, implant design, and surgical technique.it measured using the osstell through Resonance Frequency Analysis,Higher ISQ values indicate greater primary stability.more than 70 ISQ is considerd high stability. Achieving good primary stability is crucial for implant success, as it helps prevent micromovements and supports proper secondary (biological) stability during healing,

    at the time of surgery

Secondary Outcomes (1)

  • secondary stability

    after 12 weeks

Study Arms (4)

tapered implant with conventional preparation

EXPERIMENTAL

The osteotomy will be performed following the manufacturer's standard drilling sequence without osseodensification. This group will serve to evaluate the effect of conventional implant site preparation on the primary and secondary stability of tapered implants

Procedure: Dental Implant Placement with Osseodensification or Conventional Drilling

tapered with osseodensification

EXPERIMENTAL

The osteotomy will be prepared with densifying burs operated in a non-subtractive, counterclockwise direction to compact and preserve bone tissue. This approach aims to enhance bone density and improve the primary and secondary stability of the tapered implants

Procedure: Dental Implant Placement with Osseodensification or Conventional Drilling

cylindrical implant with conventional preparation

EXPERIMENTAL

The osteotomy will be performed following the standard sequential drilling protocol recommended by the manufacturer, without applying osseodensification. This group will be used to assess the effect of conventional implant site preparation on the primary and secondary stability of cylindrical implants

Procedure: Dental Implant Placement with Osseodensification or Conventional Drilling

cylindrical with osseodensification

EXPERIMENTAL

The osteotomy will be performed using densifying burs in a non-subtractive, counterclockwise direction, which compacts and preserves the surrounding bone tissue. This method is intended to increase bone density and improve both primary and secondary implant stability for cylindrical implants

Procedure: Dental Implant Placement with Osseodensification or Conventional Drilling

Interventions

Placement of tapered or cylindrical dental implants using osseodensification (bone-compacting technique) or conventional drilling to evaluate implant stability.

cylindrical implant with conventional preparationcylindrical with osseodensificationtapered implant with conventional preparationtapered with osseodensification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are willing to comply with the study and give their consent. 2-Ability to tolerate conventional surgical and restorative procedure. 3- Healthy patients over 18 years of either gender, having single or multiple missing teeth in the maxilla and/or mandible

You may not qualify if:

  • Active infection or inflammation in implant area or neighboring zone.
  • Systemic conditions (medically compromised patient) such as uncontrolled diabetes, coagulation disorders, immune compromised patient, patient treated with bisphosphate drugs, psychiatric problems or unrealistic expectations, pregnant women, any medical condition that affect bone healing.
  • Clinical evidence of parafunctional habits.
  • Active periodontitis.
  • Heavy smokers (≥20 cigarettes a day).
  • Advanced and complicated cases.
  • Patients who not able to follow the treatment protocol or lost during the study period.
  • Patient with history of radiotherapy to the head and neck -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university of baghdad college of dentistry Teaching hospital

Baghdad, Baghdad Governorate, 10001, Iraq

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The Effect of Osseodensification Versus Conventional Implant Site Preparation on the Primary Stability of Tapered and Cylindrical Dental Implant

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 24, 2025

Study Start

December 3, 2024

Primary Completion

December 11, 2025

Study Completion

March 11, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Locations