Marginal Bone Loss in Single Implant Restaurations With Different Methods

February 8, 2024 updated by: Patricia Truchuelo, Universidad de León

Marginal Bone Loss in Single Implant Restaurations With Three Different Methods

The investigator is going to measure the marginal bone loss in single implant restaurations with three different methods: direct overcast, milled cad/cam direct to implant restauration and milled cad/cam implant restauration using an transepithelial pilar

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigator has chosen a statistically significant sample (compared with other similar studies) to analize the bone marginal loss in different types of restauration with single dental implants

Study Type

Interventional

Enrollment (Estimated)

59

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Spain
    • Leon
      • León, Leon, Spain, 24071
        • Universidad de León

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

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients with single implants restaurations treated in Leon University

Exclusion Criteria:

  • pregnant
  • mayor heath issues
  • patients who do not agree to participate

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Overcast implant single restauration
Device: Bti Unit
Comparison with or without the device
Active Comparator: Cad/cam direct implant restauration
Device: Bti Unit
Comparison with or without the device
Active Comparator: Cad/cam implant restauration with transepithelial pilar
Device: Bti Unit
Comparison with or without the device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of marginal loss in single dental implants
Time Frame: 6 months
To evaluate the vertical loss of bone in milimiters around the implant
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Implants with Prosthetic complications
Time Frame: 6 months
The investigator is going to analyze if there is porcelain chipping (yes or not) and screw loosening (yes or not)
6 months

Collaborators and Investigators

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

Sponsor

Universidad de León

Investigators

  • Study Director: Jesus Seco, Universidad de León

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)

September 1, 2022

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

February 26, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULeon

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Bone marginal loss

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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