Effect of Implant Macro-Design and Surface Treatment on Insertion Torque and Early Implant Stability Quotient (ISQ)

Summary

This prospective, randomized pilot clinical trial will evaluate the effect of dental implant macro-design and surface treatment on insertion torque values (ITV) and early implant stability quotient (ISQ) trajectories in healed posterior mandibular bone. The study has been approved by the Vilnius University Regional Bioethics Committee (approval no. 2025/11-1722-1165) and will be conducted at a private dental clinic (Dantų implantologijos centras, Vilnius, Lithuania).

Fifty implants will be randomly allocated to five groups of ten implants each, comparing two implant macro-designs - Straumann Bone Level Tapered (BLT) and Megagen BlueDiamond (BD) - combined with different surface treatments: (1) BLT with a sandblasted, large-grit, acid-etched (SLA®) surface plus chairside vacuum plasma activation (XActive®); (2) BLT with a manufacturer-hydrophilic SLActive® surface; (3) BD with a nanostructured calcium-incorporated Xpeed® surface plus chairside plasma activation; (4) BD with the standard Xpeed® surface (no plasma activation); and (5) BLT with a standard SLA surface (control, no plasma activation). Randomization will be performed by drawing a sealed envelope indicating group assignment immediately after osteotomy preparation and before implant placement.

Eligible participants will be adults aged 18 years or older requiring a single dental implant in a healed mandibular molar site (at least 3 months post-extraction) suitable for a 4.1 × 10 mm implant.

Insertion torque will be recorded in Newton centimeters (Ncm) using a prosthetic torque wrench at the time of implant placement. Implant stability will be measured non-invasively by resonance frequency analysis (RFA) using a SmartPeg, with ISQ recorded at four timepoints: at implant placement (baseline) and at 2, 4, and 6 weeks after placement. The primary comparisons will be (1) insertion torque according to implant macro-design (BLT vs. BD) and (2) the trajectory of ISQ change from baseline through 6 weeks according to surface treatment/plasma activation status. Correlation between insertion torque and ISQ will also be assessed. Also marginal bone maintenance (loss) will be documented from periapical radiographs obtained during prosthetic and 1 year follow-up visits.

As a pilot study, this trial is designed to assess feasibility, estimate effect sizes, and inform sample-size calculations for a future, adequately powered randomized controlled trial comparing implant macro-design and surface activation strategies for early implant stability.

Conditions

• Dental Implant Macrodesign
• Dental Implant Surface Treatment
• Dental Implant Primary Stability
• Dental Implant Secondary Stability
• Dental Implant Stability Quotient (ISQ)
• Effects of Dental Implant Macrodesign and Surface Treatment on Primary and Secondary Stability

Interventions

DEVICE

Chairside implant surface treatment with Plasma X Motion device

XActive® chairside plasma surface activation (Plasma X Motion system) applied

DEVICE

SLA implant surface

Manufacturer SLA implant surface

DEVICE

Straumann BLT implant macro design

Straumann Bone Level Tapered implant macro design

DEVICE

SLActive implant surface treatment

Manufacturer SLActive surface treatment

DEVICE

Megagen BD implant macro design

Megagen BlueDiamond implant macro design

DEVICE

Megagen Xpeed implant surface treatment

Megagen Xpeed manufacturer implant surface treatment

Sponsors & Collaborators

• MegaGen

  collaborator UNKNOWN

• Dantu implantologijos centras

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-13

Primary Completion

2026-09-18

Completion

2026-09-30

Countries

• Lithuania

Study Locations