Dental ImplantSMART-ACCURACYNCT07373548
Long-Term Clinical and Radiographic Outcomes Following Freehand and Guided Dental Implant Placement: A Randomized Controlled Trial Follow-Up
A study testing dental implant placement in people with Dental Implant and Edentulism, run by SmileDent Kft. at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dental Implant, Edentulism, Navigation
- What is being tested?
- dental implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteHungary
- Study dates
- 11 Feb 2019to 30 Sep 2024
- Phase
- Interventional
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The original clinical trial was designed to compare the accuracy of freehand and guided dental implant placement using different levels of surgical navigation. A total of 101 partially edentulous volunteers were enrolled and randomly assigned to one of four surgical protocols: freehand implantation, pilot-guided implantation, partially guided implantation, or fully guided implantation. Implant placement accuracy was evaluated by comparing the digitally planned implant positions with the actual postoperative implant positions using three-dimensional computerized analysis.
The present investigation represents an extended follow-up of this cohort, conducted to assess the long-term clinical performance of the placed implants. Follow-up evaluations began in February 2019 and continued until September 2024, resulting in a total observation period of up to 67 months. The extended duration exceeded the originally planned follow-up due to logistical interruptions related to the COVID-19 pandemic.
Clinical follow-up focused on peri-implant tissue health and marginal bone stability. Peri-implant probing depth was recorded as a clinical indicator of soft tissue conditions around the implants after delivery of the definitive prosthetic restorations. Measurements were performed at standardized sites around each implant, and mean probing depth values were calculated for longitudinal analysis.
Radiographic follow-up was performed using standardized bitewing radiographs to assess marginal bone levels. Marginal bone level was defined as the vertical distance between the implant platform and the alveolar crest, measured both mesially and distally. Because radiographic projection angles could not be fully standardized across all visits, individual calibration was performed for each implant using the known implant neck diameter provided by the manufacturer. This allowed reliable two-dimensional measurements despite variations in radiographic geometry.
The primary objective of this follow-up study is to describe long-term peri-implant clinical and radiographic outcomes following implant placement performed with varying levels of surgical guidance. Secondary objectives include assessing the stability of marginal bone levels over time and identifying potential differences between surgical protocols in long-term biological performance.
- Conditions
- Dental Implant, Edentulism, Navigation
- Being tested
- dental implant placement
- Keywords
- static guidance accuracy, dental implant, long-term follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant placementProcedure or surgery
placing dental implants
| Study group | Role | What they receive |
|---|---|---|
| free hand | Experimental | free hand implant placement Receives: Procedure: dental implant placement |
| pilot | Experimental | pilot static guided implant placement Receives: Procedure: dental implant placement |
| partial | Experimental | partial static guided implant placement Receives: Procedure: dental implant placement |
| full | Experimental | full static guided implant placement Receives: Procedure: dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 67 months post-implant placement
Secondary outcomes (8)
Long-Term Tolerability and Safety
Assessment of the long-term tolerability and safety of the implanted dental implants based on the occurrence of adverse events and complications.
Measured: Up to 67 months post-implant placement
Number of events of prosthodontic complications
Prosthodontic complications of the screw-retained implant-supported veneered zirconia prostheses in both arches were monitored and recorded throughout the 67-month follow-up period. Complications were calculated based on the occurrence of the following events: loss of access-hole cover, framework fracture, veneering ceramic fracture, prosthetic tooth fracture, abutment screw loosening, abutment screw fracture, prosthesis screw loosening, and prosthesis screw fracture.
Measured: From prosthetic delivery up to 67 months of follow-up
Oral Health-Related Quality of Life Assessed by the OHIP-14 Questionnaire
Patient-reported oral health-related quality of life assessed longitudinally using the validated Hungarian version of the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The OHIP-14 evaluates the impact of dental implants and implant-supported prosthetic restorations on functional, physical, psychological, and social aspects of daily life.
Measurement Tool: OHIP-14 questionnaire (14 items). Unit of Measure: Total OHIP-14 score (sum score ranging from 0 to 56), where higher scores indicate poorer oral health-related quality of life.
Method of Assessment: For each visit, individual item scores (5-point Likert scale: 0 = never to 4 = very often) are summed to calculate a total OHIP-14 score. Mean total scores are calculated across the study population at each visit to evaluate changes in oral health-related quality of life over time.
Measured: Up to 67 months post-implant placement
Marginal Bone Loss
Long-term assessment of peri-implant marginal bone changes using standardized radiographic evaluation.
Unit of Measure: Millimeters (mm)
Measured: From prosthetic delivery up to 67 months of follow-up
Probing Depth
Long-term assessment of peri-implant soft tissue health by measuring probing depth around dental implants.
Unit of Measure: Millimeters (mm)
Measured: From prosthetic delivery up to 67 months of follow-up
Gingival Index
Long-term assessment of peri-implant gingival inflammation using the Gingival Index score.
Unit of Measure: Score (Units on a Scale)
Measured: From prosthetic delivery up to 67 months of follow-up
Plaque Index
Long-term assessment of oral hygiene status around dental implants using the Plaque Index score.
Measured: From prosthetic delivery up to 67 months of follow-up
Width of Keratinized Gingiva
Long-term assessment of peri-implant soft tissue characteristics by measuring the width of keratinized gingiva.
Unit of Measure: Millimeters (mm)
Measured: From prosthetic delivery up to 67 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start11 Feb 2019
- Primary completion11 Feb 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, adaptive, parallel study with four arms
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- SmileDent Kft.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373548
- Sponsor's protocol ID
- IMP SMART 2224-4/2019
- Acronym
- SMART-ACCURACY
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No