Gingival RecessionBOPTNCT06485999
Periodontal Outcomes and Digital Volumetric Variation Following BOPT Restorations
An observational study of Gingival Recession, run by University of Valencia at 1 site in Spain.
Trial summary
Technology is becoming increasingly essential in dentistry, and many procedures now require the use of an intraoral scanner. The goal of scanning the oral cavity is to create digital impressions, which are crucial for the fabrication of any dental prosthesis, as three-dimensional models of the dentition are needed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Biologically Oriented Preparation Technique
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2024to 10 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have received prosthetic treatment at the Clinics of Odontology at the University of Valencia in the last 3 years, using the biological oriented preparation technique.
Who may be able to join
- patients who had been treated previously by BOPT technique.
- patients aged over 18 years.
Who cannot join
- Cases where the scanners cannot be overlapping.
Trial locations and contacts
1 site in 1 country.
About this study
Technology is becoming increasingly essential in dentistry, and many procedures now require the use of an intraoral scanner. The goal of scanning the oral cavity is to create digital impressions, which are crucial for the fabrication of any dental prosthesis, as three-dimensional models of the dentition are needed.
Alongside technological advancements, new techniques for preparation in fixed dental prosthetics are being developed. An example is the BOPT technique, which involves vertical tooth preparation without a finishing line, associated with gingival sulcus curettage. The technique aims to improve the health and stability of gingival tissues over time.
Since it is a technique still not widely used, there is a need to intensify studies on the subject, justifying the conduct of this observational research aimed at assessing, through scanning and image overlay programs, the volumetric change of gingival tissues after the installation of ceramic prostheses with BOPT-type carving
Read the detailed description
The aim of this study was to analyze the behavior of the periodontal tissues around teeth in the anterior region when restored with zirconia single crowns, using a biologically oriented preparation technique (BOPT). The study will investigate tooth-supported single crowns in the anterior region that were fabricated with a full zirconia core, in 18 patients, in the past 3 years. Follow-up analysis will measure periodontal responses by evaluating the following variables: plaque index (PI); probing depth (PD); gingival index (GI); and gingival thickness adjacent to the restoration using intraoral scanning.
The images of the scanning before and after BOPT restoration will be overlap by using a software tool named Geomagic. This program can quantify the changes of gingival thickness in different points defined by the investigator.
- Conditions
- Gingival Recession
- Being tested
- Biologically Oriented Preparation Technique
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologically Oriented Preparation TechniqueProcedure or surgery
Also called Vertical tooth preparation.
It is a preparation technique without a finish line, also known as the biologically oriented preparation technique (BOPT). In this protocol, the crown's anatomic emergence profile at the cementoenamel junction (CEJ) is eliminated with diamond rotary instruments to create a new prosthetic junction, adapted to the gingival margin. The aim of this protocol is to create a new anatomic crown with a prosthetic emergence profile that simulates the shape of the natural tooth.
| Study group | Role | What they receive |
|---|---|---|
| Teeth treated with the Biologically Oriented Preparation Technique (BOPT) | No interventions will be administered. Receives: Procedure: Biologically Oriented Preparation Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Volumetric Variation
Variation of gingival tickness following BOPT technique
Measured: May 2024
Secondary outcomes (3)
Plaque Index
Index of bacterial plaque
Measured: May 2024
Probing Depth
Depht of gingival sulcus
Measured: May 2024
Gingival Index
Index for measure the gingival inflammation
Measured: May 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start2 Mar 2024
- Primary completion10 May 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Agustín-Panadero, University of Valencia
- Investigators
- Ruben A Panadero, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485999
- Sponsor's protocol ID
- UV-INV_ETICA-3325009
- Acronym
- BOPT
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Outcomes and Digital Volumetric Variation Following BOPT Restorations
- ClinicalTrials.gov ID
- NCT06485999
- Acronym / sponsor ID
- BOPT / UV-INV_ETICA-3325009
- Conditions
- Gingival Recession
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 3 Jul 2024 (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.
Technology is becoming increasingly essential in dentistry, and many procedures now require the use of an intraoral scanner. The goal of scanning the oral cavity is to create digital impressions, which are crucial for the fabrication of any dental prosthesis, as three-dimensional models of the dentition are needed.
Alongside technological advancements, new techniques for preparation in fixed dental prosthetics are being developed. An example is the BOPT technique, which involves vertical tooth preparation without a finishing line, associated with gingival sulcus curettage. The technique aims to improve the health and stability of gingival tissues over time.
Since it is a technique still not widely used, there is a need to intensify studies on the subject, justifying the conduct of this observational research aimed at assessing, through scanning and image overlay programs, the volumetric change of gingival tissues after the installation of ceramic prostheses with BOPT-type carving
Detailed description
The aim of this study was to analyze the behavior of the periodontal tissues around teeth in the anterior region when restored with zirconia single crowns, using a biologically oriented preparation technique (BOPT). The study will investigate tooth-supported single crowns in the anterior region that were fabricated with a full zirconia core, in 18 patients, in the past 3 years. Follow-up analysis will measure periodontal responses by evaluating the following variables: plaque index (PI); probing depth (PD); gingival index (GI); and gingival thickness adjacent to the restoration using intraoral scanning.
The images of the scanning before and after BOPT restoration will be overlap by using a software tool named Geomagic. This program can quantify the changes of gingival thickness in different points defined by the investigator.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teeth treated with the Biologically Oriented Preparation Technique (BOPT) | – | Procedure: Biologically Oriented Preparation TechniqueNo interventions will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received prosthetic treatment at the Clinics of Odontology at the University of Valencia in the last 3 years, using the biological oriented preparation technique.
Key inclusion criteria (2 listed)
- patients who had been treated previously by BOPT technique.
- patients aged over 18 years.
Key exclusion criteria (1 listed)
- Cases where the scanners cannot be overlapping.
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 |
|---|---|---|
| Biologically Oriented Preparation TechniqueAlso: Vertical tooth preparation.It is a preparation technique without a finish line, also known as the biologically oriented preparation technique (BOPT). In this protocol, the crown's anatomic emergence profile at the cementoenamel junction (CEJ) is eliminated with diamond rotary instruments to create a new prosthetic junction, adapted to the gingival margin. The aim of this protocol is to create a new anatomic crown with a prosthetic emergence profile that simulates the shape of the natural tooth. | Procedure or surgery | Teeth treated with the Biologically Oriented Preparation Technique (BOPT) |
Primary outcome
Gingival Volumetric Variation
Time frame: May 2024
Variation of gingival tickness following BOPT technique
3 secondary outcomes
Plaque Index
Time frame: May 2024
Probing Depth
Time frame: May 2024
Gingival Index
Time frame: May 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ruben A Panadero, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Recession, run by University of Valencia at 1 site in Spain.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gingival Volumetric Variation (time frame: May 2024). 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 3 Jul 2024.