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

NCT07744776 | Recruiting DMC

• 1 other identifier: SLActive vs SLA Xactive
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

dental implant macro design; dental implant surface treatment; early implant stability; osseointegration; primary stability; secondary stability; SLActive; Xpeed; Xactive; XpeedActive; SLA; Plasma X motion; ISQ; ITV; insertion torque value; Implant Stability Quotient; Vacuum plasma; Plasma treatment; hydrophilic surface; hydrocarbon

Outcome Measures

Primary Outcomes (2)

• Implant Insertion Torque Value (ITV)

  Insertion torque will be recorded in Newton-centimeters (Ncm) using a prosthetic torque wrench at the moment of implant seating, prior to healing abutment connection. ITV will be compared between the two implant macro-designs (Straumann Bone Level Tapered vs. Megagen BlueDiamond), pooling across surface treatment/activation status, to evaluate the effect of implant macrogeometry on primary mechanical stability.

  Day 1

• Implant Stability Quotient (ISQ)

  Implant stability will be measured non-invasively by resonance frequency analysis (RFA) using a SmartPeg transducer attached to the implant's internal connection. Two perpendicular readings (bucco-lingual and mesio-distal) will be obtained at each timepoint using a manufacturer-recommended 45-degree probe angle, and their average will be recorded as the ISQ value for that visit. The change in ISQ (ΔISQ) from baseline will be calculated at each follow-up timepoint (W2, W4, W6) for each of the five study arms, to evaluate the trajectory of early implant stability according to implant macro-design and surface treatment/activation.

  Baseline (day 1) and at 2, 4, and 6 weeks post-placement

Secondary Outcomes (4)

• Vertical gingival thickness

  Day 1

• Implant placement depth

  Day 1

• Buccal vertical gingival thickness

  8 weeks

• Marginal bone level

  At the time of prosthetic rehabilitation of the implant and at the time of the 1 year follow-up visit.

Study Arms (5)

Straumann Bone Level Tapered implants SLA with Plasma X Motion treatment (BLT SLA XActive)

EXPERIMENTAL

Participants will receive a Straumann Bone Level Tapered (BLT) implant with a conventional sandblasted, large-grit, acid-etched (SLA) surface. Immediately prior to placement, the implant will undergo chairside low-temperature vacuum plasma surface activation using the Plasma X Motion system (XActive®), performed according to the manufacturer's protocol (approximately 50-second activation cycle) immediately before insertion into the prepared osteotomy.

Device: Chairside implant surface treatment with Plasma X Motion device; Device: SLA implant surface; Device: Straumann BLT implant macro design

Straumann Bone Level Tapeded implants with SLActive surface (BLT SLActive)

EXPERIMENTAL

Participants will receive a Straumann Bone Level Tapered (BLT) implant with the manufacturer hydrophilic SLActive surface. No chairside plasma activation will be performed; the hydrophilic, hydrocarbon-free surface state is achieved during manufacturing and preserved through storage in isotonic saline under nitrogen until use

Device: Straumann BLT implant macro design; Device: SLActive implant surface treatment

MegaGen BlueDiamond implants Xpeed surface treated using Plasma X Motion (BD XpeedActive)

EXPERIMENTAL

Participants will receive a Megagen BlueDiamond (BD) implant with the nanostructured calcium-incorporated Xpeed® surface. Immediately prior to placement, the implant will undergo chairside low-temperature vacuum plasma surface activation using the Plasma X Motion system (XActive®), performed according to the manufacturer's protocol immediately before insertion into the prepared osteotomy.

Device: Chairside implant surface treatment with Plasma X Motion device; Device: Megagen BD implant macro design; Device: Megagen Xpeed implant surface treatment

MegaGen BlueDiamond implants Xpeed surface (BD Xpeed)

EXPERIMENTAL

Participants will receive a Megagen BlueDiamond (BD) implant with the manufacturer nanostructured calcium-incorporated Xpeed® surface, without any chairside plasma activation.

Device: Megagen BD implant macro design; Device: Megagen Xpeed implant surface treatment

Straumann Bone Level Tapeded implants with SLActive surface (BLT SLA)

ACTIVE COMPARATOR

Participants will receive a Straumann Bone Level Tapered (BLT) implant with a conventional sandblasted, large-grit, acid-etched (SLA) surface, without any chairside plasma activation and without a manufacturer-integrated hydrophilic treatment. This arm serves as the reference/control group for surface-treatment comparisons.

Device: SLA implant surface; Device: Straumann BLT implant macro design

Interventions

Chairside implant surface treatment with Plasma X Motion device DEVICE

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

MegaGen BlueDiamond implants Xpeed surface treated using Plasma X Motion (BD XpeedActive); Straumann Bone Level Tapered implants SLA with Plasma X Motion treatment (BLT SLA XActive)

SLA implant surface DEVICE

Manufacturer SLA implant surface

Straumann Bone Level Tapeded implants with SLActive surface (BLT SLA); Straumann Bone Level Tapered implants SLA with Plasma X Motion treatment (BLT SLA XActive)

Straumann BLT implant macro design DEVICE

Straumann Bone Level Tapered implant macro design

Straumann Bone Level Tapeded implants with SLActive surface (BLT SLA); Straumann Bone Level Tapeded implants with SLActive surface (BLT SLActive); Straumann Bone Level Tapered implants SLA with Plasma X Motion treatment (BLT SLA XActive)

SLActive implant surface treatment DEVICE

Manufacturer SLActive surface treatment

Straumann Bone Level Tapeded implants with SLActive surface (BLT SLActive)

Megagen BD implant macro design DEVICE

Megagen BlueDiamond implant macro design

MegaGen BlueDiamond implants Xpeed surface (BD Xpeed); MegaGen BlueDiamond implants Xpeed surface treated using Plasma X Motion (BD XpeedActive)

Megagen Xpeed implant surface treatment DEVICE

Megagen Xpeed manufacturer implant surface treatment

MegaGen BlueDiamond implants Xpeed surface (BD Xpeed); MegaGen BlueDiamond implants Xpeed surface treated using Plasma X Motion (BD XpeedActive)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Requiring a dental implant in a healed mandibular molar site (≥ 3 months post-extraction)
• Site anatomy suitable for placement of a 4.1 × 10 mm implant
• Bleeding on probing \< 20%
• Plaque index \< 25%

You may not qualify if:

• Smoking ≥ 10 cigarettes/day
• History of uncontrolled periodontitis
• Uncontrolled diabetes
• Alcoholism
• Use of medication known to impair bone healing

Sponsors & Collaborators

• Dantu implantologijos centras: lead
• MegaGen: collaborator

Study Sites (1)

Dantu implantologijos centras

Vilnius, 08216, Lithuania

RECRUITING

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Central Study Contacts

Marius Svedas

CONTACT

+37069829987; svedasm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: August 4, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)