Movement of Dental Implants During Osseointegration
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAula Dental Avanzada
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial population
Consecutive adult patients in good general health who require a single dental implant-supported restoration in private clinical practice. Participants will be recruited from three collaborating dental clinics in Spain (Alicante, Murcia, and Tenerife). All candidates will be screened according to inclusion and exclusion criteria and will receive standard implant therapy under routine clinical conditions. Each participant contributes one implant, which constitutes the analytical unit of the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Adults receiving a single dental implant
Trial outcomes
Primary outcomes
1
3D positional change (linear and angular) from T0 to T1
Linear displacement (mm) and angular change (degrees) assessed by superimposing post-surgical (T0) and pre-loading (T1) intraoral STL scans using certified software.
Time frame
3-4 months post-placement (pre-loading visit).Secondary outcomes
1
Change in implant stability (ISQ2 vs. ISQ1)
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.
Time frame
3-4 months after implant placement (pre-loading visit).2
Association between 3D displacement and insertion torque
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.
Time frame
3-4 months after implant placement.3
Proportion of implants with linear displacement >0.15 mm
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).
Time frame
3-4 months after implant placement.4
Influence of anatomical, surgical, and patient-related variables on 3D displacement
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.
Time frame
3-4 months after implant placement.Sponsors and contacts
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Source ClinicalTrials.gov
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