Soft TissuesNCT04403230
Outcomes on Teeth Prepared With BOPT
A study testing Retreatment of teeth prepared without finish line in people with Soft Tissues and Prosthetic, run by University of Valencia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissues, Prosthetic, Outcome
- What is being tested?
- Retreatment of teeth prepared without finish line
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patients who were smokers.
- patients who presented unmanaged parafunctional habits.
- patients with severe systemic diseases.
About this study
Official title: 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.
Read the 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.
- Conditions
- Soft Tissues, Prosthetic, Outcome
- Being tested
- Retreatment of teeth prepared without finish line
- Keywords
- BOPT, dental preparation, dental crown, zirconia, periodontal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retreatment of teeth prepared without finish lineProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Retreatment of teeth prepared without finish line |
What is being measured
The primary outcome is the main question the study is designed to answer.
A possible periodontal complications
Analyze periodontal outcome on teeth prepared with biologically oriented preparation technique
Measured: Through study completion, an average of 15 years.
biological or mechanical prosthetic complications
Analyze prosthetic outcome on teeth prepared with biologically oriented preparation technique
Measured: 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).
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.
Measured: Through study completion, an average of 15 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Jan 2013
- Primary completion1 Jan 2014
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft TissuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca Serra, University of Valencia
- Investigators
- Blanca Serra Pastor, Professor, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403230
- Sponsor's protocol ID
- H1448361523684
- Status last verified
- Jul 2026
- First submitted
- 20 May 2020
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal and Prosthetic Outcomes on Teeth Prepared With Biologically Oriented Preparation Technique: Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04403230
- Acronym / sponsor ID
- H1448361523684
- Conditions
- Soft Tissues, Prosthetic, Outcome
- Keywords
- BOPT, dental preparation, dental crown, zirconia, periodontal health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jan 2014 (actual)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Clinical behaviour on teeth prepared without finish line | Experimental | Procedure: Retreatment of teeth prepared without finish lineEvaluate 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- patients who were smokers.
- patients who presented unmanaged parafunctional habits.
- patients with severe systemic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retreatment of teeth prepared without finish lineRetreatment 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). | Procedure or surgery | Clinical behaviour on teeth prepared without finish line |
Primary outcome
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
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
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blanca Serra Pastor, Professor principal investigator
University of Valencia
Questions about this trial
What is this clinical trial studying?
A study testing Retreatment of teeth prepared without finish line in people with Soft Tissues and Prosthetic, run by University of Valencia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A possible periodontal complications (time frame: Through study completion, an average of 15 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.