NCT04403230

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
44mo left

Started Jan 2013

Longer than P75 for not_applicable

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Jan 2013Jan 2030

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
9.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Expected
Last Updated

May 7, 2021

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 20, 2020

Last Update Submit

May 6, 2021

Conditions

Keywords

BOPTdental preparationdental crownzirconiaperiodontal health

Outcome Measures

Primary Outcomes (2)

  • A possible periodontal complications

    Analyze periodontal outcome on teeth prepared with biologically oriented preparation technique

    Through study completion, an average of 15 years.

  • 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 Outcomes (1)

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

    Through study completion, an average of 15 years.

Study Arms (1)

Clinical behaviour on teeth prepared without finish line

EXPERIMENTAL

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

Interventions

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).

Clinical behaviour on teeth prepared without finish line

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Blanca Serra Pastor, Professor

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 27, 2020

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion (Estimated)

January 1, 2030

Last Updated

May 7, 2021

Record last verified: 2020-05