Osseodensification Drilling TechniquePhase 2NCT07610317

Pain and Anxiety Associated With Osseodensification

A Phase 2 study testing Osseodensification techniques, Conventional drilling technique and Osseodensification technique in people with Osseodensification Drilling Technique and Dental Implants, run by Ordu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Osseodensification Drilling Technique, Dental Implants
What is being tested?: Osseodensification techniques, Conventional drilling technique and Osseodensification technique
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Apr 2023to 30 Apr 2024
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ordu University, Ordu, Ordu 52100
Ordu, Ordu University,, 52100

Other trials in Turkey (Türkiye)

About this study

Official title: Pain and Anxiety Levels Experienced by Patients Undergoing the Conventional and Osseodensification Drilling Techniques

Read the detailed description

In this prospective randomized clinical trial, 72 patients receiving 337 dental implants were assigned to conventional drilling or osseodensification groups. Postoperative pain was assessed using a Visual Analog Scale (VAS) at immediate, 24-hour, 72-hour, and 10-day intervals. Dental anxiety was evaluated using the Modified Dental Anxiety Scale (MDAS). Implant stability was measured using insertion torque and implant stability quotient (ISQ) values at placement and after 3 months.

Conditions: Osseodensification Drilling Technique, Dental Implants
Being tested: Osseodensification techniques, Conventional drilling technique, Osseodensification technique
Keywords: Osseodensification, Dental implants, Implant stability quotient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Osseodensification techniquesProcedure or surgery
Osteotomies prepared using densifying burs (Densah® burs, Versah, USA) operated in counterclockwise (densifying) mode at 1200 rpm with constant saline irrigation.
Conventional drilling techniqueProcedure or surgery
Standard sequential osteotomy performed using gradually increasing diameter drills at 800 rpm under copious irrigation
Osseodensification techniqueProcedure or surgery
Osteotomies prepared using densifying burs (Densah® burs, Versah, USA) operated in counterclockwise (densifying) mode at 1200 rpm with constant saline irrigation.

Study groups in NCT07610317
Study group	Role	What they receive
Test group	Active comparator	Osseodensification techniques Receives: Procedure: Osseodensification techniques; Procedure: Osseodensification technique
Control group	Placebo comparator	Conventional drilling techniques Receives: Procedure: Conventional drilling technique

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain perception
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
Measured: Baseline
Pain perception
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 3 rd smonth after surgery

Secondary outcomes (3)

Dental Anxiety (MDAS)
Dental anxiety will be assessed using the Modified Dental Anxiety Scale (MDAS). Total MDAS scores range from 5 to 25, with higher scores indicating greater levels of dental anxiety.
Measured: baseline
Dental Anxiety (MDAS)
Dental anxiety will be assessed using the Modified Dental Anxiety Scale (MDAS). Total MDAS scores range from 5 to 25, with higher scores indicating greater levels of dental anxiety.
Measured: 10th day after surgery
Insertion Torque (IT)
Primary implant stability assessed by insertion torque values (Ncm) recorded during implant placement using a calibrated torque wrench.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 202330 Apr 2024

First posted27 May 2026
Study start15 Apr 2023
Primary completion30 Apr 2024
Study completion30 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Osseodensification Drilling TechniqueStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07610317
Sponsor's protocol ID: 2023\08
Status last verified: Jun 2026
First submitted: 20 May 2026
Last updated: 4 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effectiveness of Clockwise vs. Counter-Clockwise Osseodensification for Implant Site Preparation
Osseodensification Drilling Technique
Not yet recruiting
Clinical, Radiographic, Histological, and Patient-reported/ Experience Outcome Measures of Endoscopically-monitored Graftless Transcrestal Sinus Floor Elevation With Simultaneous Multiple Implant Placement Using Osseodensification(OD) Versus Osteotomes (OT) in Subsinus Bone Height of 4-5 mm: An RCT
Osseodensification Drilling Technique
Not yet recruiting
Comparative Assessment of Primary Stability by Osseodensification Using Densah Burs Conventional Drilling Methods.
Patient With Low Denisty Bone
Enrolling by invitation
Magnetic Mallet Vs Conventional Drilling in D4 Posterior Maxilla
Alveolar Bone Loss, Dental Implant
Enrolling by invitation
Osseodensification vs Conventional Drilling for Immediate Dental Implant Placement
Immediate Dental Implant Placement, Conventional Drilling Technique

All Osseodensification Drilling Technique trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pain and Anxiety Levels Experienced by Patients Undergoing the Conventional and Osseodensification Drilling Techniques
ClinicalTrials.gov ID: NCT07610317
Acronym / sponsor ID: 2023\08
Conditions: Osseodensification Drilling Technique, Dental Implants
Keywords: Osseodensification, Dental implants, Implant stability quotient
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Ordu UniversityUniversity, hospital or other
Study start: 15 Apr 2023 (actual)
Primary completion: 30 Apr 2024 (actual)
Study completion: 30 Apr 2024 (actual)
First posted: 27 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Test group	Active comparator	Procedure: Osseodensification techniques, Procedure: Osseodensification techniqueOsseodensification techniques
Control group	Placebo comparator	Procedure: Conventional drilling techniqueConventional drilling techniques

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Osseodensification techniquesOsteotomies prepared using densifying burs (Densah® burs, Versah, USA) operated in counterclockwise (densifying) mode at 1200 rpm with constant saline irrigation.	Procedure or surgery	Test group
Conventional drilling techniqueStandard sequential osteotomy performed using gradually increasing diameter drills at 800 rpm under copious irrigation	Procedure or surgery	Control group
Osseodensification techniqueOsteotomies prepared using densifying burs (Densah® burs, Versah, USA) operated in counterclockwise (densifying) mode at 1200 rpm with constant saline irrigation.	Procedure or surgery	Test group

Primary outcome

Pain perception
Time frame: Baseline
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
Pain perception
Time frame: 1st day after surgery
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
Pain perception
Time frame: 3th day after surgery
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
Pain perception
Time frame: 10th day after surgery
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
Implant Stability Quotient (ISQ)
Time frame: Baseline
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.
Implant Stability Quotient (ISQ)
Time frame: 3 rd smonth after surgery
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 secondary outcomes

Dental Anxiety (MDAS)
Time frame: baseline
Dental Anxiety (MDAS)
Time frame: 10th day after surgery
Insertion Torque (IT)
Time frame: baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
Individual participant dataSharing planned: No

Related trials for Osseodensification Drilling Technique

Active, not recruiting
Effectiveness of Clockwise vs. Counter-Clockwise Osseodensification for Implant Site Preparation
Osseodensification Drilling Technique
Not yet recruiting
Clinical, Radiographic, Histological, and Patient-reported/ Experience Outcome Measures of Endoscopically-monitored Graftless Transcrestal Sinus Floor Elevation With Simultaneous Multiple Implant Placement Using Osseodensification(OD) Versus Osteotomes (OT) in Subsinus Bone Height of 4-5 mm: An RCT
Osseodensification Drilling Technique
Not yet recruiting
Comparative Assessment of Primary Stability by Osseodensification Using Densah Burs Conventional Drilling Methods.
Patient With Low Denisty Bone
Enrolling by invitation
Magnetic Mallet Vs Conventional Drilling in D4 Posterior Maxilla
Alveolar Bone Loss, Dental Implant
Enrolling by invitation
Osseodensification vs Conventional Drilling for Immediate Dental Implant Placement
Immediate Dental Implant Placement, Conventional Drilling Technique

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain perception (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07610317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.