- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04403230
Outcomes on Teeth Prepared With BOPT
Periodontal and Prosthetic Outcomes on Teeth Prepared With Biologically Oriented Preparation Technique: Prospective Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Blanca Serra Pastor, Professor, University of Valencia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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