Dental ImplantsMOVs-OINCT07297147
Movement of Dental Implants During Osseointegration
An observational study of Dental Implants and Osseointegration, run by Aula Dental Avanzada at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants, Osseointegration
- How many people
- 100 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jan 2026to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Guillem Esteve-Pardo, PhD contact
Spain3 sites, 3 recruiting
- Recruiting
Clínica Dental Esteve
Alicante, Alicante, 03001
Guillem Esteve-Pardo, PhD, +34 965215755, guillem@clinicaesteve.com
Guillem Esteve-Pardo, PhD
- Recruiting
Clínica Dental Sánchez Nicolás
Cabezo de Torres, Murcia, 30110
Jose Antonio Sánchez-Nicolás, DDS, +34 968907578, josedentistacabezo@hotmail.com
José Antonio Sánchez-Nicolás, DDS
- Recruiting
Clínica Dental García Marí
Santa Cruz de Tenerife, Tenerife, 38006
Antonio Luis García-Marí, DDS, +34 922 27 69 96, clinica@garciamari.com
Antonio Luis García-Marí, DDS, +34 922 276 996, clinica@garciamari.com
About this study
Official title: Do Dental Implants Move During Osseointegration? A Prospective Multicenter Clinical Study Using Intraoral Scan Superimposition and Stability Analysis.
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.
Read the 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.
- Conditions
- Dental Implants, Osseointegration
- Keywords
- Dental implants, Osseointegration, Intraoral scan, Micromotion, ISQ, Insertion torque, Bruxism
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-4 months post-placement (pre-loading visit).
Secondary outcomes (4)
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.
Measured: 3-4 months after implant placement (pre-loading visit).
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.
Measured: 3-4 months after implant placement.
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).
Measured: 3-4 months after implant placement.
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.
Measured: 3-4 months after implant placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aula Dental Avanzada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillem Esteve-Pardo, Aula Dental Avanzada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297147
- Sponsor's protocol ID
- MOVSOI
- Acronym
- MOVs-OI
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified implant-level and patient-level data will be made available upon reasonable request after publication of the main study results. Shared materials will include the full dataset (excluding any directly identifying information), the data dictionary, and the main statistical analysis code. Access requests must be submitted in writing to the study sponsor (Clínica Dental Esteve, S.L.) and will be reviewed by the principal investigator to ensure compliance with ethical and privacy regulations. Data will be provided through a secure repository or encrypted transfer.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Dental Implants Move During Osseointegration? A Prospective Multicenter Clinical Study Using Intraoral Scan Superimposition and Stability Analysis.
- ClinicalTrials.gov ID
- NCT07297147
- Acronym / sponsor ID
- MOVs-OI / MOVSOI
- Conditions
- Dental Implants, Osseointegration
- Keywords
- Dental implants, Osseointegration, Intraoral scan, Micromotion, ISQ, Insertion torque, Bruxism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aula Dental AvanzadaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3D positional change (linear and angular) from T0 to T1
Time frame: 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.
4 secondary outcomes
Change in implant stability (ISQ2 vs. ISQ1)
Time frame: 3-4 months after implant placement (pre-loading visit).
Association between 3D displacement and insertion torque
Time frame: 3-4 months after implant placement.
Proportion of implants with linear displacement >0.15 mm
Time frame: 3-4 months after implant placement.
Influence of anatomical, surgical, and patient-related variables on 3D displacement
Time frame: 3-4 months after implant placement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified implant-level and patient-level data will be made available upon reasonable request after publication of the main study results. Shared materials will include the full dataset (excluding any directly identifying information), the data dictionary, and the main statistical analysis code. Access requests must be submitted in writing to the study sponsor (Clínica Dental Esteve, S.L.) and will be reviewed by the principal investigator to ensure compliance with ethical and privacy regulations. Data will be provided through a secure repository or encrypted transfer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillem Esteve-Pardo, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants and Osseointegration, run by Aula Dental Avanzada at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillem Esteve-Pardo, PhD (+34 965215755, guillem@clinicaesteve.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D positional change (linear and angular) from T0 to T1 (time frame: 3-4 months post-placement (pre-loading visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.