NCT07373548

Brief Summary

This study is a long-term clinical follow-up of a previously conducted randomized trial comparing different levels of surgical guidance in dental implant placement. The follow-up phase aims to evaluate peri-implant clinical and radiographic outcomes over an extended observation period of up to 67 months. Clinical parameters and marginal bone level changes are assessed to determine whether the accuracy benefits observed at implant placement translate into favorable long-term biological outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

January 2, 2026

Last Update Submit

January 20, 2026

Conditions

Dental ImplantEdentulismNavigation

Keywords

static guidance accuracydental implantlong-term follow-up

Outcome Measures

Primary Outcomes (1)

  • Implant Survival

    Long-term survival of dental implants placed in the four study arms defined in the IMP SMART 002 trial, evaluated as a direct temporal extension of the IMP SMART 002 protocol (OGYÉI approval number 2224-4/2019). Implant survival is defined as the implant remaining in situ and functional without removal.

    Up to 67 months post-implant placement

Secondary Outcomes (8)

  • Long-Term Tolerability and Safety

    Up to 67 months post-implant placement

  • Number of events of prosthodontic complications

    From prosthetic delivery up to 67 months of follow-up

  • Oral Health-Related Quality of Life Assessed by the OHIP-14 Questionnaire

    Up to 67 months post-implant placement

  • Marginal Bone Loss

    From prosthetic delivery up to 67 months of follow-up

  • Probing Depth

    From prosthetic delivery up to 67 months of follow-up

  • +3 more secondary outcomes

Study Arms (4)

free hand

EXPERIMENTAL

free hand implant placement

Procedure: dental implant placement

pilot

EXPERIMENTAL

pilot static guided implant placement

Procedure: dental implant placement

partial

EXPERIMENTAL

partial static guided implant placement

Procedure: dental implant placement

full

EXPERIMENTAL

full static guided implant placement

Procedure: dental implant placement

Interventions

dental implant placementPROCEDURE

placing dental implants

free handfullpartialpilot

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 years
  • Partial edentulism in the maxilla or mandible involving 1-6 missing teeth, with no more than three adjacent missing teeth
  • Clinical conditions suitable for implant placement as assessed by the investigator or principal investigator (adequate bone and soft tissue conditions and acceptable occlusion)
  • Ability to communicate effectively with the investigators and willingness to comply with study procedures
  • Provision of written informed consent

You may not qualify if:

  • Pregnancy or breastfeeding
  • Women of childbearing potential without adequate contraception (for radiological safety reasons)
  • Conditions preventing safe intraoral manipulation (e.g., limited mouth opening, pronounced gag reflex)
  • Current or previous bisphosphonate therapy
  • History of radiotherapy involving the maxilla or mandible
  • International normalized ratio (INR) \> 2.5
  • Known HIV, hepatitis B, or hepatitis C infection
  • Known allergy to any component of the implant or surgical guide system
  • Poor oral hygiene
  • Substance abuse
  • Smoking
  • Untreated periodontal disease
  • Any systemic disease or condition judged by the principal investigator to pose an unacceptable risk to the participant or to compromise study completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Smile Dent

Szeged, Csongrád megye, 6724, Hungary

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, adaptive, parallel study with four arms
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 28, 2026

Study Start

February 11, 2019

Primary Completion

February 11, 2024

Study Completion

September 30, 2024

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

HU(1)