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NCT Number: NCT07610317

Pain and Anxiety Associated With Osseodensification

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.

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Key information

Conditions

Osseodensification Drilling Technique Dental Implants

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ordu University, Ordu, Ordu 52100

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osseodensification techniques

Procedure

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

Conventional drilling technique

Procedure

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

Osseodensification technique

Procedure

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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.

  6. 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.

Secondary outcomes

  1. Dental Anxiety (MDAS)

    Time frame: baseline

    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.

  2. Dental Anxiety (MDAS)

    Time frame: 10th day after surgery

    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.

  3. Insertion Torque (IT)

    Time frame: baseline

    Primary implant stability assessed by insertion torque values (Ncm) recorded during implant placement using a calibrated torque wrench.

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 27, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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