Dental Implants, Osseointegration
Conditions
Keywords
Dental implants, Osseointegration, Intraoral scan, Micromotion, ISQ, Insertion torque, Bruxism
Brief summary
Prospective multicenter observational study assessing whether dental implants undergo three-dimensional positional change between placement (T0) and pre-loading after osseointegration (T1). Two intraoral scans (STL) will be superimposed to quantify linear (mm) and angular (degrees) displacement. Clinical variables include insertion torque, primary and secondary ISQ, anatomical site, placement timing, operator-perceived bone density (Lekholm & Zarb), bruxism, and night guard use. The primary endpoint is the 3D displacement at \ 3-4 months. Multivariable analyses will explore associated factors.
Detailed description
This is a prospective multicenter observational study designed to evaluate whether dental implants undergo measurable three-dimensional positional changes during the osseointegration period. The study will be conducted in three private dental clinics in Spain, each led by an experienced implantologist. Consecutive adult patients indicated for a single implant-supported restoration will be enrolled after providing written informed consent. Immediately after implant placement (T0), a reference intraoral scan (STL format) will be obtained using a validated scanner. A second intraoral scan will be performed after approximately 3 to 4 months, prior to prosthetic loading (T1). The two STL datasets will be superimposed using certified metrology software to calculate both linear (mm) and angular (degrees) displacement of the implant position relative to stable reference structures. The software alignment protocol ensures a reproducible and rigid registration of both scans. Clinical and procedural variables collected at surgery include insertion torque value (ITV), primary implant stability (ISQ1), implant site (maxilla or mandible; anterior, premolar, or molar region), timing of placement (immediate or delayed), and operator-perceived bone density according to the Lekholm and Zarb classification. At the pre-loading visit (T1), secondary stability (ISQ2) will be recorded together with information on bruxism and the use of night guards. The primary outcome is the 3D positional change (linear and angular) of the implant between T0 and T1. Secondary outcomes include the evolution of implant stability (ISQ2-ISQ1), correlations between displacement and insertion torque, and the influence of anatomical and patient-related variables (site, bone quality, bruxism, and loading protocol) on implant micromotion. All data will be anonymized and analyzed at the implant level. Descriptive statistics will summarize means, standard deviations, and confidence intervals. Paired comparisons will be used to test within-subject changes, and multivariable linear regression models will explore predictors of displacement. Statistical significance will be set at p \< 0.05. The results of this study are expected to contribute to understanding whether clinically relevant implant micromovement occurs during osseointegration and to identify factors influencing this phenomenon, potentially guiding decisions on early loading and implant design optimization.
Interventions
None listed
Sponsors
Aula Dental Avanzada
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older. * Indication for a single implant-supported restoration. * Good general health and absence of active periodontal disease. * Willingness to provide written informed consent and to undergo two intraoral scans (immediately after implant placement - T0 - and before prosthetic loading - T1).
Exclusion criteria
* Uncontrolled systemic disease or any medical condition contraindicating implant surgery. * High-risk antiresorptive therapy (e.g., intravenous bisphosphonates or denosumab). * Pregnancy or breastfeeding, if applicable to local policy. * Inability to attend the T1 follow-up visit or contraindication to intraoral scanning (e.g., limited mouth opening, severe gag reflex).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3D positional change (linear and angular) from T0 to T1 | 3-4 months post-placement (pre-loading visit). | Linear displacement (mm) and angular change (degrees) assessed by superimposing post-surgical (T0) and pre-loading (T1) intraoral STL scans using certified software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in implant stability (ISQ2 vs. ISQ1) | 3-4 months after implant placement (pre-loading visit). | Difference in implant stability values measured by resonance frequency analysis between placement (ISQ1) and pre-loading (ISQ2). The mean ISQ gain will be analyzed and correlated with the magnitude of 3D displacement. |
| Association between 3D displacement and insertion torque | 3-4 months after implant placement. | Evaluation of the correlation between linear and angular displacement (T0-T1) and the insertion torque value (ITV) recorded at implant placement. The aim is to determine whether higher primary mechanical stability predicts lower micromotion during osseointegration. |
| Proportion of implants with linear displacement >0.15 mm | 3-4 months after implant placement. | Percentage of implants showing a linear displacement greater than 0.15 mm between T0 and T1, considered an exploratory biological threshold of potential micromotion. Sensitivity analyses will also be conducted using alternative thresholds (0.10-0.20 mm). |
| Influence of anatomical, surgical, and patient-related variables on 3D displacement | 3-4 months after implant placement. | Multivariable analysis evaluating the influence of anatomical site (maxilla/mandible; anterior/premolar/molar), timing of placement (immediate/delayed), operator-perceived bone density (Lekholm & Zarb), and bruxism/night-guard use on 3D implant displacement. |
Countries
Spain
Contacts
Primary ContactGuillem Esteve-Pardo, PhD
Backup ContactGuillem Esteve-Pardo, PhD
Outcome results
None listed