Outcomes on Teeth Prepared With BOPT

Sponsor

University of Valencia (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04403230

Collaborator

(none)

Enrollment

Arm

204

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Soft Tissues Prosthetic Outcome	Procedure: Retreatment of teeth prepared without finish line	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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).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).

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jan 1, 2014

Anticipated Study Completion Date :

Jan 1, 2030

Arms and Interventions

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.	Procedure: Retreatment of teeth prepared without finish line 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).

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.

Procedure: Retreatment of teeth prepared without finish line

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).

Outcome Measures

Primary Outcome Measures

A possible periodontal complications [Through study completion, an average of 15 years.]
Analyze periodontal outcome on teeth prepared with biologically oriented preparation technique
biological or mechanical prosthetic complications [Through study completion, an average of 15 years.]
Analyze prosthetic outcome on teeth prepared with biologically oriented preparation technique

Secondary Outcome Measures

Patient's level of satisfaction with treatment assessed by means of a visual analogue scale (VAS). [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Valencia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Valencia

ClinicalTrials.gov Identifier:

NCT04403230

Other Study ID Numbers:

H1448361523684

First Posted:

May 27, 2020

Last Update Posted:

May 7, 2021

Last Verified:

May 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Valencia

Study Results

No Results Posted as of May 7, 2021