AbfractionNCT05861193
Treatment of NCCL Asociated With Gingival Recession With B.O.P.T. Technique
A study testing Treatment of the abfraction with BOPT technique in people with Abfraction, run by University of Valencia at 1 site in Spain.
Trial summary
The purpose of this clinical trial is to evaluate the gingival margin changes resulting from the treatment with biologically oriented preparation technique (B.O.P.T.) of non-carious cervical lesions (NCCL). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abfraction
- What is being tested?
- Treatment of the abfraction with BOPT technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2022to 1 Jul 2023
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age, all sex;
- Presence of a non-carious lesion with loss of dental hard tissue, located in the cervical third of the tooth, and associated with R1 Cairo dental recession; as well, the tooth must be in a healthy condition.
Who cannot join
- In the tooth to be treated: presence of tartar, periodontal pocket, gingival hypertrophy and/or dental mobility grades II and III; as well as presence of necrosis, fractures and prosthetic restorations;
- Presence of diabetes, coagulopathies, hemostatic and hormonal alterations, smoking habit of more than 10 cigarettes/day;
- Patients being treated with drugs whose side effects may cause gingival hypertrophy (eg hydantoins);
- Presence of any physical and/or mental condition that prevents voluntary giving informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical trial is to evaluate the gingival margin changes resulting from the treatment with biologically oriented preparation technique (B.O.P.T.) of non-carious cervical lesions (NCCL). In particular, the quantification of the cervical margin is carried out by an intraoral scanning device, both in length and width.
- Conditions
- Abfraction
- Being tested
- Treatment of the abfraction with BOPT technique
- Keywords
- NCCL, B.O.P.T., Gingival recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of the abfraction with BOPT techniqueProcedure or surgery
The steps to follow for the treatment of abfraction using composite resin and the B.O.P.T. technique will consist of:
- Selection of the color of the composite, placement of the retraction cord and chamfering of the coronal margin of the lesion;
- Application of 37% phosphoric acid etching and adhesive in 3 steps; placement of the composite by layers, following the conventional obturation technique.
- Execution of an overfilling with the composite at the level of the cervical emergence profile of the tooth, with the aim of emphasizing said anatomical particularity.
- Removal of the retraction cord.
- Diamond milling with red rim flame diamond bur and contra-angle, positioned from the most apical point of the restoration at an angle of 45º without touching the restored dental portion, with the aim of performing a level rotary gingival curettage from the margin of the restoration.
- Polishing with a fine-grain flame bur, and polishing discs of decreasing granulometry.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | Patients belonging to the intervention group presented abfraction lesions in upper and/or lower premolars. These abfraction lesions consist of a loss of dental hard tissue at the cervical level of more than 1 mm, and are associated with type 1 gingival recession of the Cairo classification. Receives: Procedure: Treatment of the abfraction with BOPT technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
On the tooth to be treated: Measurement of gingival recession associated to abfraction (before/after treatment).
The gingival recession associated with the abfraction lesion is digitally measured (in mm) through intraoral scanning of the same. Gingival recession is measured from the most coronal portion of the gingival margin to the cementoenamel junction at 3 fixed points (in mesial, medial, and distal).
A software allows to overlay the initial scan with the post treatment scan; thus, the changes obtained thanks to the treatment in the height of the gingival margin are objectively measured.
Measured: The initial scan is performed prior to treatment, lasting approximately 5 minutes (maximum). The final scan is performed three month after treatment, once the gingival tissues have healed.
On the tooth to be treated: Measurement of the volume of gingiva at the level of the gingival margin (before/after treatment).
The volume of the gingival tissue at the level of the margin, is measured through an initial intraoral scan, at 3 fixed points (the same points measured in the gingival recession, see outcome 1), from the outermost part of the gingiva to the outermost portion of the tooth root, seen in an occlusal view.
A software allows to overlay the initial scan with the post treatment scan; thus, the volumetric changes obtained thanks to the treatment in the gingival margin are objectively measured.
Measured: The initial scan is performed prior to treatment, lasting approximately 5 minutes (maximum). The final scan is performed three month after treatment, once the gingival tissues have healed.
Secondary outcomes (1)
Periodontal probing of all teeth
Value measured with a Williams periodontal probe with markings at 1-2-3-5-7-8-9-10 mm, from the bottom of the gingival sulcus to the gingival margin at 3 points (mesial, medial and distal).
Measured: Before and after 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start20 Sep 2022
- Primary completion20 May 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbfractionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruben Agustin Panadero, PDI-Titular, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861193
- Sponsor's protocol ID
- UV-INV_ETICA-2404840
- Status last verified
- Feb 2023
- First submitted
- 28 Feb 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of NCCL Asociated With Gingival Recession With B.O.P.T. Technique
- ClinicalTrials.gov ID
- NCT05861193
- Acronym / sponsor ID
- UV-INV_ETICA-2404840
- Conditions
- Abfraction
- Keywords
- NCCL, B.O.P.T., Gingival recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 20 May 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 16 May 2023 (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 purpose of this clinical trial is to evaluate the gingival margin changes resulting from the treatment with biologically oriented preparation technique (B.O.P.T.) of non-carious cervical lesions (NCCL). In particular, the quantification of the cervical margin is carried out by an intraoral scanning device, both in length and width.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Procedure: Treatment of the abfraction with BOPT techniquePatients belonging to the intervention group presented abfraction lesions in upper and/or lower premolars. These abfraction lesions consist of a loss of dental hard tissue at the cervical level of more than 1 mm, and are associated with type 1 gingival recession of the Cairo classification. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years of age, all sex;
- Presence of a non-carious lesion with loss of dental hard tissue, located in the cervical third of the tooth, and associated with R1 Cairo dental recession; as well, the tooth must be in a healthy condition.
Key exclusion criteria (4 listed)
- In the tooth to be treated: presence of tartar, periodontal pocket, gingival hypertrophy and/or dental mobility grades II and III; as well as presence of necrosis, fractures and prosthetic restorations;
- Presence of diabetes, coagulopathies, hemostatic and hormonal alterations, smoking habit of more than 10 cigarettes/day;
- Patients being treated with drugs whose side effects may cause gingival hypertrophy (eg hydantoins);
- Presence of any physical and/or mental condition that prevents voluntary giving informed consent to participate in the study.
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 |
|---|---|---|
| Treatment of the abfraction with BOPT techniqueThe steps to follow for the treatment of abfraction using composite resin and the B.O.P.T. technique will consist of: * Selection of the color of the composite, placement of the retraction cord and chamfering of the coronal margin of the lesion; * Application of 37% phosphoric acid etching and adhesive in 3 steps; placement of the composite by layers, following the conventional obturation technique. * Execution of an overfilling with the composite at the level of the cervical emergence profile of the tooth, with the aim of emphasizing said anatomical particularity. * Removal of the retraction cord. * Diamond milling with red rim flame diamond bur and contra-angle, positioned from the most apical point of the restoration at an angle of 45º without touching the restored dental portion, with the aim of performing a level rotary gingival curettage from the margin of the restoration. * Polishing with a fine-grain flame bur, and polishing discs of decreasing granulometry. | Procedure or surgery | Cases |
Primary outcome
On the tooth to be treated: Measurement of gingival recession associated to abfraction (before/after treatment).
Time frame: The initial scan is performed prior to treatment, lasting approximately 5 minutes (maximum). The final scan is performed three month after treatment, once the gingival tissues have healed.
The gingival recession associated with the abfraction lesion is digitally measured (in mm) through intraoral scanning of the same. Gingival recession is measured from the most coronal portion of the gingival margin to the cementoenamel junction at 3 fixed points (in mesial, medial, and distal). A software allows to overlay the initial scan with the post treatment scan; thus, the changes obtained thanks to the treatment in the height of the gingival margin are objectively measured.
On the tooth to be treated: Measurement of the volume of gingiva at the level of the gingival margin (before/after treatment).
Time frame: The initial scan is performed prior to treatment, lasting approximately 5 minutes (maximum). The final scan is performed three month after treatment, once the gingival tissues have healed.
The volume of the gingival tissue at the level of the margin, is measured through an initial intraoral scan, at 3 fixed points (the same points measured in the gingival recession, see outcome 1), from the outermost part of the gingiva to the outermost portion of the tooth root, seen in an occlusal view. A software allows to overlay the initial scan with the post treatment scan; thus, the volumetric changes obtained thanks to the treatment in the gingival margin are objectively measured.
1 secondary outcome
Periodontal probing of all teeth
Time frame: Before and after 3 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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 Agustin Panadero, PDI-Titular 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?
A study testing Treatment of the abfraction with BOPT technique in people with Abfraction, 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 4 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: status not confirmed, as of the sponsor's last update on 16 May 2023. 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?
Results are not available in the source record.
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?
On the tooth to be treated: Measurement of gingival recession associated to abfraction (before/after treatment). (time frame: The initial scan is performed prior to treatment, lasting approximately 5 minutes (maximum). The final scan is performed three month after treatment, once the gingival tissues have healed.). 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 16 May 2023.