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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04403230
Other study ID # H1448361523684
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2013
Est. completion date January 1, 2030

Study information

Verified date May 2020
Source University of Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 52
Est. completion date January 1, 2030
Est. primary completion date January 1, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Outcome

Type Measure Description Time frame Safety issue
Primary A possible periodontal complications Analyze periodontal outcome on teeth prepared with biologically oriented preparation technique Through study completion, an average of 15 years.
Primary biological or mechanical prosthetic complications Analyze prosthetic outcome on teeth prepared with biologically oriented preparation technique Through study completion, an average of 15 years.
Secondary Patient's level of satisfaction with treatment assessed by means of a visual analogue scale (VAS). 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.
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