Outcomes on Teeth Prepared With BOPT

May 6, 2021 updated by: University of Valencia

Periodontal and Prosthetic Outcomes on Teeth Prepared With Biologically Oriented Preparation Technique: Prospective Clinical Study

The aim of this study is to evaluate the clinical and biological behavior of full coverage restorations on teeth prepared without finish line in a prospective clinical study.

Study Overview

Status

Active, not recruiting

Detailed Description

The purpose is to evaluate the clinical and biological behavior of full coverage restorations on teeth prepared without finish line.

This prospective study included 149 teeth treated using biologically oriented preparation technique (BOPT). The sample (149 teeth) was divided into two groups: Seventy four teeth restored with crowns, and 75 teeth supporting fixed partial dentures (FPD). Restorations were fabricated with zirconium oxide cores and ceramic coverings. Patients attended regular annual check-ups when probe depth, presence of inflammation with bleeding on probing, presence of plaque, gingival thickness, marginal stability, biological or mechanical complications, and the patient's level of satisfaction were registered.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients (aged over 18 years).
  • non-smokers.
  • periodontally healthy or periodontally managed.
  • patients who had undergone restoration with fixed prostheses (one-piece crowns or fixed partial dentures FPDs) in the aesthetic zone (incisors, canines, premolars, first molars), which needed to be replaced due to biological, esthetic or some other type of problem.

Exclusion Criteria:

  • patients who were smokers.
  • patients who presented unmanaged parafunctional habits.
  • patients with severe systemic diseases.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical behaviour on teeth prepared without finish line
Evaluate the clinical behavior of restorations placed on teeth prepared without finish line, monitoring periodontal status as well as the prostheses to assess stability and treatment predictability.
Retreatment of teeth treated using biologically oriented preparation technique (BOPT). The sample (149 teeth) was divided into two groups: Seventy four teeth restored with crowns, and 75 teeth supporting fixed partial dentures (FPD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A possible periodontal complications
Time Frame: Through study completion, an average of 15 years.
Analyze periodontal outcome on teeth prepared with biologically oriented preparation technique
Through study completion, an average of 15 years.
biological or mechanical prosthetic complications
Time Frame: Through study completion, an average of 15 years.
Analyze prosthetic outcome on teeth prepared with biologically oriented preparation technique
Through study completion, an average of 15 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's level of satisfaction with treatment assessed by means of a visual analogue scale (VAS).
Time Frame: Through study completion, an average of 15 years.
Patient's satisfaction was assesed using a ''Visual Analogue Scale'' (VAS). In wich 0 is the the minimum and 10 de maximum value, and whether higher scores mean a better outcome.
Through study completion, an average of 15 years.

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Blanca Serra Pastor, Professor, University of Valencia

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)

January 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Anticipated)

January 1, 2030

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • H1448361523684

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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