Dynamic Follow-up of Factors Influencing Implant Success and Models for Predicting Implant Outcomes

November 16, 2024 updated by: Yi Zhou, The Dental Hospital of Zhejiang University School of Medicine
Nowadays, artificial intelligence technology with machine learning as the main means has been increasingly applied to the oral field, and has played an increasingly important role in the examination, diagnosis, treatment and prognosis assessment of oral diseases. Among them, machine learning is an important branch of artificial intelligence, which refers to the system learning specific statistical patterns in a given data set to predict the behavior of new data samples [8]. Machine learning is divided into two main categories: Supervised learning and Unsupervised learning. Whether there is supervision depends on whether the data entered is labeled or not. If the input data is labeled, it is supervised learning. Unlabeled learning is unsupervised. Supervised learning is a kind of learning algorithm when the correct output of the data set is known. Because the input and output are known, it means that there is a relationship between the input and output, and the supervised learning algorithm is to discover and summarize this "relationship". Unsupervised learning refers to a class of learning algorithms for unlabeled data. The absence of label information means that patterns or structures need to be discovered and summarized from the data set.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Starting from different data types, researchers built a variety of models to mine the data itself and predict the prognosis of the implant. Machine learning is often more impressive and intuitive in terms of images. In the field of oral implantology, researchers analyze preoperative image data based on machine learning to identify important anatomical structures (such as maxillary sinus, mandibular neural tube, etc.) and analyze alveolar bone quality. Large-scale imaging data is also used to identify the different implant systems on the market. Machine learning also plays an important role in the development of implant surgery plans, which is conducive to more accurate and efficient implantation surgery. The evaluation of implant retention rate and individual bone level is also one of the key clinical concerns. Most methods to study such issues are: Kaplan-Meier survival analysis, Cox survival analysis, etc., to study implant retention rate and influencing factors. Linear (mixed) model and multiple logistic regression were used to study the changes and influencing factors of bone absorption at implant edge. However, in daily clinical practice, there may be some practical problems such as lost follow-up and partial data missing. As the clinical scenarios of research become more and more clear, even partial data missing often leads to results that cannot be accurately evaluated and predicted. Therefore, in terms of supervised learning, this study aims to establish a predictive model of implant bone level change and evaluate the accuracy of the model through machine learning of implant edge bone level (MBL) with large amounts of data. In terms of unsupervised learning, the aim is to identify susceptibility phenotypes to implant failure through: clustering of individual-related information about implants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The Stomatologic Hospital, School of Medicine, Zhejiang University
        • Contact:
          • Yi Zhou
          • Phone Number: 0571 87217419
        • Contact:
          • Siyao Ma
          • Phone Number: 0571 87217419

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

This was a retrospective study. After searching the literature identified by the sample size of the combined model prediction method, it was determined that the initial data and follow-up data of 1000 patients were required.

Description

Inclusion Criteria:

  • Patients aged 18 years and above;
  • 1-5 years after implantation;
  • Implantation torque > 35N·cm;
  • Signed informed consent.

Exclusion Criteria:

  • Contraindications of general implantation surgery;
  • Have received head and neck radiation therapy;
  • Past or current treatment with bisphosphonates;
  • Do not cooperate with the interviewer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Bone Level of dental implant
Time Frame: 1-7 years
The vertical distance between the implant and the first contact area of bone and the tip of the implant (mesial and distal)
1-7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Dental Hospital of Zhejiang University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Weida Li, Stomatological Hospital Affiliated to Zhejiang University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DHZhejiangU-2022(005)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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