Movement of Dental Implants During Osseointegration

NCT07297147 | Not Yet Recruiting DMC

• 1 other identifier: MOVSOI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Dental Implants; Osseointegration

Keywords

Dental implants; Osseointegration; Intraoral scan; Micromotion; ISQ; Insertion torque; Bruxism

Outcome Measures

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.

  3-4 months post-placement (pre-loading visit).

Secondary Outcomes (4)

• Change in implant stability (ISQ2 vs. ISQ1)

  3-4 months after implant placement (pre-loading visit).

• Association between 3D displacement and insertion torque

  3-4 months after implant placement.

• Proportion of implants with linear displacement >0.15 mm

  3-4 months after implant placement.

• Influence of anatomical, surgical, and patient-related variables on 3D displacement

  3-4 months after implant placement.

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aula Dental Avanzada: lead

Study Sites (3)

Clínica Dental Esteve

Alicante, Alicante, 03001, Spain

Location

Clínica Dental Sánchez Nicolás

Cabezo de Torres, Murcia, 30110, Spain

Location

Clínica Dental García Marí

Santa Cruz de Tenerife, Tenerife, 38006, Spain

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Central Study Contacts

Guillem Esteve-Pardo, PhD

CONTACT

+34 965215755; guillem@clinicaesteve.com

Guillem Esteve-Pardo, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available beginning 6 months after publication of the primary results and for a minimum of 5 years thereafter.
• Access Criteria: Qualified researchers affiliated with academic or non-profit institutions may request access to de-identified implant-level and patient-level data, the data dictionary, and the main analysis code. Requests must include a brief research proposal and be submitted in writing to the study sponsor (Clínica Dental Esteve, S.L.). The principal investigator will review each request for scientific merit and ethical compliance. Approved users will sign a data use agreement and receive secure, time-limited access through an encrypted repository managed by the sponsor.

Locations

ES (3)