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

ConditionsDental Implant MacrodesignDental Implant Surface TreatmentDental Implant Primary StabilityDental Implant Secondary StabilityDental Implant Stability Quotient (ISQ)Effects of Dental Implant Macrodesign and Surface Treatment on Primary and Secondary Stability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDantu implantologijos centras

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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%

Disqualifiers

Smoking ≥ 10 cigarettes/day

History of uncontrolled periodontitis

Uncontrolled diabetes

Alcoholism

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chairside implant surface treatment with Plasma X Motion device

    Device

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

  • SLA implant surface

    Device

    Manufacturer SLA implant surface

  • Straumann BLT implant macro design

    Device

    Straumann Bone Level Tapered implant macro design

  • SLActive implant surface treatment

    Device

    Manufacturer SLActive surface treatment

  • Megagen BD implant macro design

    Device

    Megagen BlueDiamond implant macro design

  • Megagen Xpeed implant surface treatment

    Device

    Megagen Xpeed manufacturer implant surface treatment

Treatment groups

50 Participants
are divided into 5 treatment groups
Group A: Straumann Bone Level Tapered implants SLA with Plasma X Motion treatment (BLT SLA XActive)Experimental treatment 3 interventions
Group B: Straumann Bone Level Tapeded implants with SLActive surface (BLT SLActive)Experimental treatment 2 interventions
Group C: MegaGen BlueDiamond implants Xpeed surface treated using Plasma X Motion (BD XpeedActive)Experimental treatment 3 interventions
Group D: MegaGen BlueDiamond implants Xpeed surface (BD Xpeed)Experimental treatment 2 interventions
Group E: Straumann Bone Level Tapeded implants with SLActive surface (BLT SLA)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1
2

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.

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

Secondary outcomes

1

Vertical gingival thickness

Measurement will be taken with a milimeter periodontal probe after midcrestal incision and reflection of the buccal full thickness flap

Time frame
Day 1
2

Implant placement depth

Implant will be inserted 4mm deeper than the gingival margin and implant placement depth below the bony crest will be measured with a milimeter periodontal probe right after the implant insertion

Time frame
Day 1
3

Buccal vertical gingival thickness

At the time of impression making, vertical gingival thickness from the neck of the implant to the buccal gingival margin will be measured with a periodontal probe

Time frame
8 weeks
4

Marginal bone level

Radiographic evaluation of marginal bone level from the periapical radiographs obtained routinely during prosthetic and 1 year follow-up visits. Radiographic evaluation would be performed anyway at the time of these visits for other reasons than the clinical trial.

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

Other outcomes

Sponsors and contacts

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Dantu implantologijos centras

Lead sponsor

MegaGen

Collaborator

Source ClinicalTrials.gov
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