NCT06862973

Brief Summary

This study will explore the impact of single tooth implant restorations upon occlusal force distribution and the accuracy of several digital analysis methods. The biomechanical behavior of implant-supported prostheses differs from that of natural teeth, and the distribution and modulation of occlusal forces are unpredictable. The research used the Medit i700 intraoral scanner and the OccluSense system to take pre- and post-implant measurements. The research aims to determine: How are the techniques different in the registration of occlusal contacts and force magnitude? and How does occlusal balance shift following the placement of an implant? The research findings can be used to provide clinical recommendations to optimize occlusal balancing during implant prosthetics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

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

September 30, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
Last Updated

March 10, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

March 5, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

OcclusionDental ImplantOcclusal AnalysisOccluSenseMedit i700

Outcome Measures

Primary Outcomes (1)

  • Change in Occlusal Force Distribution from Pre-Implant to Post-Implant Restoration as Measured by Medit i700 and OccluSense

    Occlusal force distribution was measured before and after single-tooth implant restoration using two digital occlusal analysis methods: Medit i700 intraoral scanner and OccluSense pressure sensor system. Measurements were taken under standardized conditions, ensuring maximum intercuspation position. Medit i700 provided contact area data through intraoral scans, analyzed with CloudCompare software, while OccluSense recorded occlusal force intensity and distribution, analyzed with ImageJ software. The percentage change in occlusal contact areas and force distribution was calculated between the pre- and post-implant conditions. A statistically significant change (p \< 0.05) indicates an alteration in occlusal balance following the restoration.

    From pre-implant assessment to 2 week after final implant restoration placement.

Interventions

This study differs from other research through the comparison of two advanced digital occlusal analysis methods-OccluSense system and MEDIT i700 intraoral scanner-to measure occlusal force distribution both before and after the insertion of single-tooth implant restorations in the posterior segment. Unlike research based upon the use of articulation paper, this study employs pressure-sensitive sensor technology (OccluSense) and scanner-based occlusion analysis (MEDIT i700) to quantitatively measure occlusal contacts and force intensity using CloudCompare and ImageJ. With the analysis of the variations that take place within the pre-and-post implant occlusion, the study provides an understanding of occlusal adaptation and how to optimize occlusal adjustments to prevent implant overload and complications, differing from the research that has previously lacked both digital force mapping and longitudinal occlusal analysis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

he study population consists of adult patients requiring single posterior implant-supported restorations at Necmettin Erbakan University Faculty of Dentistry. Participants are selected based on specific inclusion criteria, including good periodontal health, a single missing tooth in the posterior region, and stable occlusion (Class I bite). Patients with a history of temporomandibular joint disorders, acute pain, occlusal dysfunction, restricted mouth opening, or prior orthodontic or surgical treatments affecting occlusion are excluded. The study aims to assess occlusal force distribution changes in a clinically relevant population undergoing implant rehabilitation, providing insights into post-restorative occlusal adjustments.

You may qualify if:

  • Individuals aged 18 and over
  • Patients with good periodontal health
  • Patients with a Class I bite
  • Patients with a single tooth deficiency in the posterior region planned for rehabilitation with an implant-supported single crown restoration

You may not qualify if:

  • History of temporomandibular joint disease
  • Acute pain or signs of occlusal dysfunction
  • Restricted mouth opening
  • Absence of a tooth distal to the planned restoration
  • Occlusion instability due to prior orthodontic or surgical treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Publications (1)

  • Gozen M, Guntekin N. Comparison of occlusal force distribution and digital occlusal analysis methods of single posterior implant restorations: an in vivo study. BMC Oral Health. 2025 May 26;25(1):795. doi: 10.1186/s12903-025-06205-w.

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, Department of Prosthodontics, Faculty of Dentistry

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 7, 2025

Study Start

September 30, 2024

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

March 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

yes, all IPD that underlie results in a publication

Shared Documents
CSR
Time Frame
April 2025-January 2026

Locations