Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2026-01-01
2027-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adults receiving a single dental implant
Consecutive adults indicated for a single implant-supported restoration treated in three private clinics in Spain. Care follows standard practice; no investigational interventions are mandated. The exposure of interest is the osseointegration period between implant placement (T0) and pre-loading (T1, \~3-4 months). At T0 and T1, intraoral scans (STL) are acquired and rigidly superimposed with certified software to quantify 3D positional change (linear, mm; angular, degrees). Clinical variables recorded include insertion torque, ISQ1/ISQ2, anatomical site (jaw/region), placement timing (immediate/delayed), operator-perceived bone density, and bruxism/night-guard use. Analyses are performed at the implant level (one implant per participant).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Aula Dental Avanzada
OTHER
Responsible Party
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Guillem Esteve-Pardo
PhD
Locations
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Clínica Dental Esteve
Alicante, Alicante, Spain
Clínica Dental Sánchez Nicolás
Cabezo de Torres, Murcia, Spain
Clínica Dental García Marí
Santa Cruz de Tenerife, Tenerife, Spain
Countries
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Central Contacts
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Guillem Esteve-Pardo, PhD
Role: CONTACT
Facility Contacts
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Guillem Esteve-Pardo, PhD
Role: primary
Jose Antonio Sánchez-Nicolás, DDS
Role: primary
Antonio Luis García-Marí, DDS
Role: primary
Antonio Luis García-Marí, DDS
Role: backup
Other Identifiers
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MOVSOI
Identifier Type: -
Identifier Source: org_study_id