NCT05301400

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

February 26, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

2.3 years

First QC Date

February 26, 2022

Last Update Submit

February 8, 2024

Conditions

Bone Loss

Outcome Measures

Primary Outcomes (1)

  • Rate of marginal loss in single dental implants

    To evaluate the vertical loss of bone in milimiters around the implant

    6 months

Secondary Outcomes (1)

  • Number of Implants with Prosthetic complications

    6 months

Study Arms (3)

Overcast implant single restauration

ACTIVE COMPARATOR
Device: Bti Unit

Cad/cam direct implant restauration

ACTIVE COMPARATOR
Device: Bti Unit

Cad/cam implant restauration with transepithelial pilar

ACTIVE COMPARATOR
Device: Bti Unit

Interventions

Bti UnitDEVICE

Comparison with or without the device

Cad/cam direct implant restaurationCad/cam implant restauration with transepithelial pilarOvercast implant single restauration

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with single implants restaurations treated in Leon University

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Leon

León, Leon, 24071, Spain

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jesus Seco

    Universidad de León

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor and principal investigator

Study Record Dates

First Submitted

February 26, 2022

First Posted

March 29, 2022

Study Start

September 1, 2022

Primary Completion

December 30, 2024

Study Completion

March 30, 2025

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Bone marginal loss

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

ES(1)