PAIN AND ANXIETY ASSOCIATED WITH OSSEODENSIFICATION

May 29, 2026 updated by: Prof.Dr. Figen ÖNGÖZ DEDE, Ordu University

PAIN AND ANXIETY LEVELS EXPERIENCED BY PATIENTS UNDERGOING THE CONVENTIONAL AND OSSEODENSIFICATION DRILLING TECHNIQUES

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Test group
Osseodensification techniques
Procedure: Osseodensification techniques
Osteotomies prepared using densifying burs (Densah® burs, Versah, USA) operated in counterclockwise (densifying) mode at 1200 rpm with constant saline irrigation.
Procedure: Osseodensification technique
Osteotomies prepared using densifying burs (Densah® burs, Versah, USA) operated in counterclockwise (densifying) mode at 1200 rpm with constant saline irrigation.
Placebo Comparator: Control group
Conventional drilling techniques
Procedure: Conventional drilling technique
Standard sequential osteotomy performed using gradually increasing diameter drills at 800 rpm under copious irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline
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)
1st day after surgery
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)
3th day after surgery
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)
10th day after surgery
Implant Stability Quotient (ISQ)
Time Frame: Baseline
Implant stability measured using resonance frequency analysis with the Osstell ISQ device; higher ISQ values indicate greater implant stability.
Baseline
Implant Stability Quotient (ISQ)
Time Frame: 3 rd smonth after surgery
Implant stability measured using resonance frequency analysis with the Osstell ISQ device; higher ISQ values indicate greater implant stability.
3 rd smonth after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental Anxiety (MDAS)
Time Frame: baseline
Dental anxiety evaluated using the Modified Dental Anxiety Scale (MDAS); higher scores indicate greater anxiety levels.
baseline
Dental Anxiety (MDAS)
Time Frame: 10th day after surgery
Dental anxiety evaluated using the Modified Dental Anxiety Scale (MDAS); higher scores indicate greater anxiety levels.
10th day after surgery
Insertion Torque (IT)
Time Frame: baseline
Primary implant stability assessed by insertion torque values (Ncm) recorded during implant placement using a calibrated torque wrench.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ordu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023\08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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