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Pain and Anxiety Associated With Osseodensification

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07610317
Enrollment
72
Registered
2026-05-27
Start date
2023-04-15
Completion date
2024-04-30
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants, Osseodensification Drilling Technique

Keywords

Osseodensification, Dental implants, Implant stability quotient

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.

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.

Interventions

PROCEDUREOsseodensification techniques

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

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

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

Sponsors

Ordu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain perceptionBaselinePresence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
Implant Stability Quotient (ISQ)BaselineImplant 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

MeasureTime frameDescription
Dental Anxiety (MDAS)baselineDental 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.
Insertion Torque (IT)baselinePrimary implant stability assessed by insertion torque values (Ncm) recorded during implant placement using a calibrated torque wrench.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026