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Bacterial Microleakage and Bone Loss in Internal Connection Dental Implants Based on the Type of Abutment Used in Zirconia Partial Fixed Prosthesis: in Vivo Study

NCT06156111 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-12-05

No results posted yet for this study

Summary

This clinical trial aims to observe if there are differences in bacterial micro-filtration on interfaces and to evaluate if there are differences in the occurrence of peri-implant diseases and bone loss in fixed partial monolithic zirconia CAD/CAM implantsupported prostheses with and without abutment in patients at the Advanced Implant Prosthetics Clinic of the Complutense University of Madrid, of both sexes, over 18 years of age, whose treatment plan is based on the replacement of dental pieces with two fixed partial dentures on implants, in such a way that the study will be performed "split mouth" rehabilitating one of them with zirconia bridges on attachments with connection and others with Zirconia bridges with flat attachments or without connection. The main question it aims to answer is whether the not use of abutment influence bacterial micro-leakage and the development of peri-implant diseases and bone loss at that level in fixed partial monolithic zirconia CAD/CAM prothesis.

Participants will:

* Receive two fixed partial monolithic zirconia CAD/CAM prothesis, one will be attached to an abutment (control group) and the other not (test group)
* Subsequently, control appointments of the fixed implant supported prosthesis treatment will be performed (1, 3,6, 12 and 24 months) and radiographies will be made with the parallelizing device attached by the silicone key.

Researchers will compare fixed partial monolithic zirconia CAD/CAM implant-supported prostheses with and without abutment to see:

* Differences in bacterial micro-leakage on interfaces.
* Occurrence of peri-implant diseases and bone loss

Conditions

  • Jaw, Edentulous, Partially

Interventions

DEVICE

Transepithelial abutment group

Before completing the essential clinical data registration to produce an individual patient-oriented prosthesis, trans-epithelial abutments on the implants randomized to this group will be put at the torque the manufacturer recommends (30 Ncm typically), according to the appropriate gingival height and then the fixed implant-supported monolithic zirconia will be placed at the torque of 15 Ncm

DEVICE

Direct to implant group

It will be registered the essential clinical data registration to produce an individual patient-oriented prosthesis, and then the fixed implant-supported monolithic zirconia will be placed at the torque of 30 Ncm.

Sponsors & Collaborators

  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

  • Miguel Gómez Polo, DDS, PhD · UComplutense de Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-26
Primary Completion
2022-11-30
Completion
2023-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06156111 on ClinicalTrials.gov