NCT07610317

Brief Summary

Primary stability is a key determinant of dental implant success, particularly in low-density bone. Osseodensification (OD) is a non-subtractive drilling technique designed to preserve and compact bone during osteotomy preparation, potentially improving implant stability while maintaining patient comfort. However, clinical evidence regarding its influence on postoperative pain and dental anxiety remains limited.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 15, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

May 20, 2026

Last Update Submit

June 2, 2026

Conditions

Osseodensification Drilling TechniqueDental Implants

Keywords

OsseodensificationDental implantsImplant stability quotient

Outcome Measures

Primary Outcomes (6)

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    Baseline

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    1st day after surgery

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    3th day after surgery

  • Pain perception

    Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)

    10th day after surgery

  • Implant Stability Quotient (ISQ)

    Implant stability will be assessed using resonance frequency analysis with the Osstell Implant Stability Quotient (ISQ) device. ISQ scores range from 1 to 100, with higher scores indicating greater implant stability.

    Baseline

  • Implant Stability Quotient (ISQ)

    Implant stability will be assessed using resonance frequency analysis with the Osstell Implant Stability Quotient (ISQ) device. ISQ scores range from 1 to 100, with higher scores indicating greater implant stability.

    3 rd smonth after surgery

Secondary Outcomes (3)

  • Dental Anxiety (MDAS)

    baseline

  • Dental Anxiety (MDAS)

    10th day after surgery

  • Insertion Torque (IT)

    baseline

Study Arms (2)

Test group

ACTIVE COMPARATOR

Osseodensification techniques

Procedure: Osseodensification techniquesProcedure: Osseodensification technique

Control group

PLACEBO COMPARATOR

Conventional drilling techniques

Procedure: Conventional drilling technique

Interventions

Osseodensification techniquesPROCEDURE

Osteotomies prepared using densifying burs (Densah® burs, Versah, USA) operated in counterclockwise (densifying) mode at 1200 rpm with constant saline irrigation.

Test group
Conventional drilling techniquePROCEDURE

Standard sequential osteotomy performed using gradually increasing diameter drills at 800 rpm under copious irrigation

Control group
Osseodensification techniquePROCEDURE

Osteotomies prepared using densifying burs (Densah® burs, Versah, USA) operated in counterclockwise (densifying) mode at 1200 rpm with constant saline irrigation.

Test group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years old,
  • requiring implant-supported tooth restorations,
  • with adequate alveolar bone volume,
  • with bone density classified as D1-D4 according to Lekholm and Zarb classification,
  • who provided written informed consent to participate in the study.

You may not qualify if:

  • uncontrolled systemic disease,
  • smoking more than 10 cigarettes per day,
  • parafunctional habits (e.g., bruxism),
  • bisphosphonate use,
  • previous grafting at the implant site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University, Ordu, Ordu 52100

Ordu, Ordu University,, 52100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

May 20, 2026

First Posted

May 27, 2026

Study Start

April 15, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)