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

September 6, 2026 updated by: Dantu implantologijos centras

Effect of Implant Macro-Design and Surface Treatment on Insertion Torque and Early Implant Stability Quotient (ISQ): A Pilot Randomized Clinical 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

XActive is a low-temperature vacuum plasma surface activation treatment (Plasma X Motion system, MegaGen Implant Co., Ltd.) applied chairside immediately prior to implant placement. Unlike manufacturer-applied hydrophilic treatments such as SLActive, this activation is performed at the point of care rather than during manufacturing, and is intended to reduce implant surface hydrocarbons and increase surface energy, thereby improving surface hydrophilicity and early implant stability. Because plasma activation is applied chairside rather than integrated into the manufacturing process, it can in principle be used with implant systems from any manufacturer, and has been shown in vitro to enhance protein adsorption and osteoblast response.

Separately, the nanostructured calcium-incorporated Xpeed® surface (used on Megagen BlueDiamond implants) has been reported to accelerate early bone formation compared with SLA surfaces in preclinical and early clinical studies, independent of plasma activation.

To date, no human randomized trial has directly compared XActive chairside plasma activation with manufacturer-applied SLActive treatment, nor has any trial investigated the combined effect of implant macro-design (Straumann BLT vs. Megagen BD) and surface treatment/activation status on ITV and early ISQ trajectories. This pilot randomized controlled trial is designed to address this gap by evaluating five implant macro-design and surface treatment combinations placed in healed posterior mandibular bone.

Study Objectives

The primary objectives of this pilot trial are:

To compare insertion torque values (ITV) between two implant macro-designs - Straumann Bone Level Tapered (BLT) and Megagen BlueDiamond (BD) - placed in healed posterior mandibular bone.

To compare early ISQ trajectories (from implant placement through 6 weeks) among five implant macro-design and surface treatment/activation combinations.

To explore the correlation between insertion torque and ISQ values at the time of implant placement.

As a pilot study, to estimate effect sizes and variability to inform the sample size calculation for a future, adequately powered randomized controlled trial.

Null Hypothesis There will be no statistically significant differences in early ISQ trajectories or insertion torque values among the five implant macro-design and surface treatment combinations placed in healed posterior mandibular bone.

Study Design This will be a prospective, randomized, pilot clinical trial with five parallel arms, conducted at a single private dental clinic (Dantų implantologijos centras, Kernavės g. 88, Vilnius, LT-08216, Lithuania). The protocol has been approved by the Vilnius University Regional Bioethics Committee (approval no. 2025/11-1722-1165).

A total of 50 implants will be enrolled, with 10 implants allocated to each of five treatment groups. This sample size is consistent with methodological recommendations for pilot studies, which suggest that small sample sizes are appropriate for feasibility assessment and estimation of variability ahead of a definitively powered trial.

Randomization and Allocation Implants will be randomly allocated to one of five groups (n=10 per group) using a sealed-envelope method. The envelope containing the group assignment will be drawn immediately after osteotomy preparation and immediately prior to implant placement, in order to standardize the timing of randomization relative to the surgical sequence.

Study Groups

Group 1 - BLT SLA XActive: Straumann Bone Level Tapered implant with a conventional SLA surface, activated chairside with the XActive plasma treatment immediately before placement.

Group 2 - BLT SLActive: Straumann Bone Level Tapered implant with the manufacturer-applied hydrophilic SLActive surface (no chairside plasma activation).

Group 3 - BD XpeedActive: Megagen BlueDiamond implant with the nanostructured calcium-incorporated Xpeed® surface, activated chairside with the XActive plasma treatment immediately before placement.

Group 4 - BD Xpeed: Megagen BlueDiamond implant with the standard Xpeed® surface (no plasma activation).

Group 5 - BLT SLA (control): Straumann Bone Level Tapered implant with the conventional SLA surface (no plasma activation).

This design allows comparison of implant macro-design independent of surface treatment (BLT vs. BD, pooling across surface/activation status) and comparison of surface treatment/activation status within each macro-design (activated vs. non-activated in both the BLT and BD systems), as well as a direct comparison of chairside plasma activation (XActive) against manufacturer-integrated hydrophilic treatment (SLActive).

Plasma Activation Procedure For implants assigned to plasma activation, the implant will be retrieved from its sterile container using the handpiece implant driver. The handpiece with the implant attached will be placed in the magnetic holder of the Plasma X Motion device, and the activation cycle will be initiated according to the manufacturer's instructions, completing automatically within approximately 50 seconds. Immediately following completion of the cycle, the magnetic holder will be removed from the device and the implant will be inserted into the prepared osteotomy according to the implant manufacturer's surgical protocol, without delay.

Surgical Procedure Two grams of amoxicillin (Ospamox, Sandoz GmbH, Austria) will be administered as a single preoperative dose; no antibiotics will be prescribed postoperatively. All surgeries will be performed under local anesthesia by the same surgeon to minimize operator variability. A mid-crestal incision will be made and a buccal mucoperiosteal flap elevated. Vertical soft tissue thickness will be measured with a periodontal probe applied to the unelevated lingual flap, after which the lingual flap will be elevated. Osteotomy preparation will follow the standard protocol recommended by the respective implant manufacturer, followed by implant insertion positioned 4 mm apical to the gingival margin. A healing abutment will be placed and sutures applied. Postoperative 0.12% chlorhexidine mouthwash will be prescribed; no postoperative antibiotics will be given.

Statistical Analysis Plan Statistical analysis will be performed using R (v. 4.0.4). Between-group comparisons of quantitative variables for two groups will use Student's t-test or the non-parametric Mann-Whitney U test, as appropriate. Comparisons among more than two groups will use one-way analysis of variance (ANOVA) or the non-parametric Kruskal-Wallis test, as appropriate. Normality of distributions will be assessed using the Shapiro-Wilk test. Paired comparisons (baseline vs. follow-up timepoints within the same implant) will use the paired t-test or Wilcoxon signed-rank test, as appropriate. Associations between insertion torque and ISQ will be assessed using Spearman correlation. Descriptive statistics will include mean, standard deviation, quartiles (Q1, Q3), median, and available number of observations for continuous variables, and absolute counts and percentages for categorical variables. A p-value <0.05 will be considered statistically significant.

Sample Size Justification As a pilot study, the planned enrollment of 10 implants per group (50 implants total) is intended to assess feasibility and estimate effect sizes and variability rather than to achieve definitive statistical power for between-group comparisons, consistent with established pilot study methodology. Data generated by this pilot will be used to perform a formal power analysis to determine the sample size required for a future, adequately powered confirmatory trial.

Significance This trial is intended to provide preliminary data on whether implant macro-design (thread geometry) and surface activation strategy (chairside plasma activation vs. manufacturer-integrated hydrophilic treatment) meaningfully influence early implant stability dynamics in healed, high-quality mandibular bone. Because chairside plasma activation systems such as XActive can, in principle, be applied to implants from any manufacturer, a favorable comparison with proprietary hydrophilic surfaces such as SLActive could have practical implications for clinical protocol selection and implant loading timelines. Findings from this pilot are also intended to inform the design, eligibility criteria, and sample size of a future confirmatory trial, potentially including sites with lower primary stability (e.g., softer bone or immediate implant placement), where surface-treatment effects on ISQ dynamics may be more pronounced.

Study Type

Interventional

Enrollment (Estimated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Marius Svedas
Phone Number: +37069829987
Email: svedasm@gmail.com

Study Locations

Lithuania
- - Vilnius, Lithuania, 08216
    - Recruiting
    - Dantu implantologijos centras
    - Contact:
      
      Marius Svedas
      
      Phone Number: 069829987
      
      Email: svedasm@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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%

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Experimental: 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	Device: Straumann BLT implant macro design Straumann Bone Level Tapered implant macro design Device: SLActive implant surface treatment Manufacturer SLActive surface treatment
Experimental: 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.	Device: Chairside implant surface treatment with Plasma X Motion device XActive® chairside plasma surface activation (Plasma X Motion system) applied Device: Megagen BD implant macro design Megagen BlueDiamond implant macro design Device: Megagen Xpeed implant surface treatment Megagen Xpeed manufacturer implant surface treatment
Experimental: 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.	Device: Megagen BD implant macro design Megagen BlueDiamond implant macro design Device: Megagen Xpeed implant surface treatment Megagen Xpeed manufacturer implant surface treatment
Active Comparator: 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.	Device: SLA implant surface Manufacturer SLA implant surface Device: Straumann BLT implant macro design Straumann Bone Level Tapered implant macro design

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Insertion Torque Value (ITV) Time Frame: 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.	Day 1
Implant Stability Quotient (ISQ) Time Frame: 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.	Baseline (day 1) and at 2, 4, and 6 weeks post-placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical gingival thickness Time Frame: Day 1	Measurement will be taken with a milimeter periodontal probe after midcrestal incision and reflection of the buccal full thickness flap	Day 1
Implant placement depth Time Frame: Day 1	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	Day 1
Buccal vertical gingival thickness Time Frame: 8 weeks	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	8 weeks
Marginal bone level Time Frame: At the time of prosthetic rehabilitation of the implant and at the time of the 1 year follow-up visit.	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.	At the time of prosthetic rehabilitation of the implant and at the time of the 1 year follow-up visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dantu implantologijos centras

Collaborators

MegaGen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

August 2, 2026

First Posted (Actual)

August 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 6, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

SLActive vs SLA Xactive

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Small sample size raising re-identification risk given the specific implant/surface combinations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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