Effect of Implant Macro-Design and Surface Treatment on Insertion Torque and Early Implant Stability Quotient (ISQ): A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Implant Insertion Torque Value (ITV)
研究概览
简要总结
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.
详细描述
Background and Rationale Dental implants play a central role in the replacement of missing teeth, and defining the earliest point at which an implant can be safely loaded functionally remains a key unresolved issue in implant dentistry. Minimizing the time to functional and aesthetic rehabilitation may improve patient satisfaction and reduce the likelihood of migration of neighboring teeth into an edentulous site. Consequently, strategies that accelerate osseointegration remain of substantial clinical interest.
Implant stability can be divided into primary stability - mechanical fixation of the implant immediately after placement - and secondary stability, which reflects the transition to biological integration through new bone apposition on the implant surface. Two non-invasive parameters are commonly used to guide decisions about loading protocols: insertion torque value (ITV), measured in Newton centimeters (Ncm), which reflects the mechanical friction between the implant and surrounding bone at placement, and implant stability quotient (ISQ), obtained through resonance frequency analysis (RFA), which indirectly reflects the density and extent of bone-to-implant contact. ITV and ISQ may correlate at the time of implant placement, and both are considered useful indicators for decisions regarding loading timing.
Primary implant stability is influenced by bone density at the implant site, osteotomy preparation technique, and implant macrogeometry. Tapered implant designs, such as the Straumann Bone Level Tapered (BLT) and Megagen BlueDiamond (BD) systems, generally achieve higher insertion torque than cylindrical designs, which is particularly relevant in low-density bone. Although both BLT and BD implants are tapered, they differ in thread depth: the BD design features deeper threads that increase implant surface area and mechanical engagement with bone, which may increase insertion torque.
Secondary stability is influenced by the same local factors as primary stability, as well as by oral hygiene, infection control, mechanical loading protocol, and patient-related biological factors affecting bone metabolism (e.g., overall health, age, smoking status). A further determinant of secondary stability is implant surface treatment, which affects the rate of protein adsorption and osteoblast adhesion and therefore the onset of osseointegration. Additionally, titanium implant surfaces are subject to biological aging through hydrocarbon deposition, which reduces surface hydrophilicity and biological activity and may slow osseointegration. Implant macro-design and surface treatment are among the few variables in implant therapy that remain fully under clinician control.
With early machined implant surfaces, healing times of 3 months (mandible) and 6 months (maxilla) prior to prosthetic loading were historically recommended. The introduction of surface treatments such as sandblasted, large-grit, acid-etched (SLA) surfaces shortened proposed healing times to 6-12 weeks. A limitation of conventional SLA surfaces is their hydrophobicity. SLActive is a chemically modified, hydrophilic variant of the SLA surface: following sandblasting and acid-etching, implants are stored in an isotonic saline solution under nitrogen to prevent hydrocarbon contamination and to preserve a highly hydrophilic titanium oxide surface, which is intended to enhance early biological response and accelerate osseointegration. Clinical and histological studies have reported that SLActive implants outperform conventional SLA surfaces in early bone apposition, bone-to-implant contact, and early ISQ values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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%
排除标准
- •Smoking ≥ 10 cigarettes/day
- •History of uncontrolled periodontitis
- •Uncontrolled diabetes
- •Alcoholism
- •Use of medication known to impair bone healing
研究组 & 干预措施
MegaGen BlueDiamond implants Xpeed surface treated using Plasma X Motion (BD XpeedActive)
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.
干预措施: Chairside implant surface treatment with Plasma X Motion device (Device)
MegaGen BlueDiamond implants Xpeed surface (BD Xpeed)
Participants will receive a Megagen BlueDiamond (BD) implant with the manufacturer nanostructured calcium-incorporated Xpeed® surface, without any chairside plasma activation.
干预措施: Megagen BD implant macro design (Device)
Straumann Bone Level Tapered implants SLA with Plasma X Motion treatment (BLT SLA XActive)
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.
干预措施: SLA implant surface (Device)
Straumann Bone Level Tapered implants SLA with Plasma X Motion treatment (BLT SLA XActive)
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.
干预措施: Chairside implant surface treatment with Plasma X Motion device (Device)
Straumann Bone Level Tapered implants SLA with Plasma X Motion treatment (BLT SLA XActive)
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.
干预措施: Straumann BLT implant macro design (Device)
Straumann Bone Level Tapeded implants with SLActive surface (BLT SLActive)
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
干预措施: Straumann BLT implant macro design (Device)
Straumann Bone Level Tapeded implants with SLActive surface (BLT SLActive)
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
干预措施: SLActive implant surface treatment (Device)
MegaGen BlueDiamond implants Xpeed surface treated using Plasma X Motion (BD XpeedActive)
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.
干预措施: Megagen BD implant macro design (Device)
MegaGen BlueDiamond implants Xpeed surface treated using Plasma X Motion (BD XpeedActive)
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.
干预措施: Megagen Xpeed implant surface treatment (Device)
MegaGen BlueDiamond implants Xpeed surface (BD Xpeed)
Participants will receive a Megagen BlueDiamond (BD) implant with the manufacturer nanostructured calcium-incorporated Xpeed® surface, without any chairside plasma activation.
干预措施: Megagen Xpeed implant surface treatment (Device)
Straumann Bone Level Tapeded implants with SLActive surface (BLT SLA)
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.
干预措施: SLA implant surface (Device)
Straumann Bone Level Tapeded implants with SLActive surface (BLT SLA)
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.
干预措施: Straumann BLT implant macro design (Device)
结局指标
主要结局
Implant Insertion Torque Value (ITV)
时间窗: Day 1
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.
Implant Stability Quotient (ISQ)
时间窗: Baseline (day 1) and at 2, 4, and 6 weeks post-placement
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.
次要结局
- 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.)