Deep CariesNCT04743219
Selective Removal Technique With or Without a Bioactive Material for Deep Caries Lesions
A study testing Selective removal to soft dentin, Biodentine and Selective removal to soft dentin, No Base in people with Deep Caries, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Objectives: To evaluate and compare clinical and radiographic success of the selective removal to soft dentine technique in one step using calcium silicate cement (Biodentine) vs. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- Selective removal to soft dentin, Biodentine and Selective removal to soft dentin, No Base
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 1 Apr 2025
- 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 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients older than 15 years.
- Parents or guardians of patients under 18 years of age, but over 15 years of age, and patients over 18 years of age who demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and who receive a signed and dated copy of the informed consent form.
- Occlusal or occlusal-proximal caries lesions, Class I or Class II, in molars or premolars with enamel margins and affecting maximum one proximal wall.
- Molar or premolar with deep caries lesion, involving equal to or greater than two thirds of dentin in depth, with a radiographically identifiable band of healthy dentin separating the pulp chamber roof from the caries lesion.
- Normal response to tests of sensitivity (normal pulp) or discomfort when cold stimulus is applied that disappears in a couple of seconds after the elimination of the stimulus (reversible pulpitits).
- Teeth with negative percussion.
Who cannot join
- Patients immunosuppressed or with severe systemic diseases.
- Teeth with root or cervical resorption.
- Teeth with obliteration of the pulp chamber.
- Periapical or furcal radiolucency.
- Patients with periodontal disease.
- Patients with spontaneous acute pain, prolonged excruciating pain and / or pain that disturbs night sleep.
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- Patients who have an allergy to any of the materials used in the treatment.
- Patients with caries lesions that during the treatment of their removal a pulp exposure is performed.
- Patients with inadequate initial radiographs for analysis.
- Evidence of pre-cancerous or cancerous lesions.
- Patients who have taken antibiotics in the last two weeks.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922
Patricia Terceño Jiménez, 659053538, ptercenojimenez@gmail.com
Laura Ceballos García, 659053538, laura.ceballos@urjc.es
About this study
Official title: Selective Removal Technique With or Without the Use of a Bioactive Material for the Management of Deep Caries Lesions in Permanent Posterior Teeth With Close Apex. A Randomized Clinical Trial.
Objectives: To evaluate and compare clinical and radiographic success of the selective removal to soft dentine technique in one step using calcium silicate cement (Biodentine) vs. no indirect pulp capping material in patients with deep caries lesions in mature permanent posterior teeth with normal or reversible pulpitis after a 2 year follow-up. Evaluate the integrity of the resin composite restorations using FDI criteria.
Material and methods: selective removal to soft dentine in one visit will be performed in 104 blinded patients that will be randomly allocated into 2 study arms, 52 patients will constitute the Biodentine group and 52 the No material group. Clinical examination will be performed to obtain pre-, intra- and postoperative data, including vitality test results, periapical status and risk of caries of the patients. Periapical and bitewing radiographs will be taken before treatment (T-0), at 1 month (T-1), 6 months (T-2), 12 months (T-3) and 24 months (T-4). Restorations will be assessed using the FDI criteria at the same follow up periods.
- Conditions
- Deep Caries
- Being tested
- Selective removal to soft dentin, Biodentine, Selective removal to soft dentin, No Base
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective removal to soft dentin, BiodentineProcedure or surgery
Carious tissue removed until its complete elimination from the lateral walls of the cavity using a round tungsten carbide bur at low speed until consistency of hard dentin around perimeter. With a manual excavator, the central cariogenic biomass will be removed, specifically the superficial part of the necrotic and demineralized caries dentin.
In the Biodentine group, Biodentine (Septodont) will be placed on the base of the cavity with a thickness of 2 mm.
The last step will be to perform a definitive direct resin restoration according to clinical indication.
Selective removal to soft dentin, No BaseProcedure or surgery
Carious tissue removed until its complete elimination from the lateral walls of the cavity using a round tungsten carbide bur at low speed until consistency of hard dentin around perimeter. With a manual excavator, the central cariogenic biomass will be removed, specifically the superficial part of the necrotic and demineralized caries dentin.
In the No base group, no bioactive material will be placed as a liner, the 3M Scothcbonf Universal Plus adhesive will be placed directly over the remaining dentin surface.
The last step will be to perform a definitive direct resin restoration according to clinical indication.
| Study group | Role | What they receive |
|---|---|---|
| Biodentine Group | Active comparator | Biodentine group: patients with mature permanent posterior teeth with deep caries lesions treated with the selective removal technique to soft dentin with Biodentine as indirect pulp capping material before placement of a definitive direct composite resin restoration. Receives: Procedure: Selective removal to soft dentin, Biodentine |
| No base Group | Experimental | The experimental group or No Base group: patients with mature permanent posterior teeth with deep caries lesions treated with the selective removal technique to soft dentin without the placement of a bioactive material as a base and restored directly with a definitive direct composite resin restoration. Receives: Procedure: Selective removal to soft dentin, No Base |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Clinical success is defined as healthy pulp, determined by a normal positive not prolonged response in the clinical examination to the cold test and the electrical test, negative response to percussion, absence of symptoms or signs of infection (abscess, fistula, swelling or inflammation) and absence of spontaneous pain.
Measured: 2 years
Secondary outcomes (1)
Radiographic success
Radiographic success is defined as the absence of widening of the periodontal ligament space (twice the equivalent of the adjacent healthy tooth) and the absence of a periapical or furcal lesion on radiographic examination. A periapical lesion is considered to be a radiolucency associated with the radiographic apex of the root of a size greater than twice the width of the periodontal ligament space.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep CariesStudies 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
- Randomised
- Intervention model
- Single group
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Terceño Jiménez, Universidad Rey Juan Carlos
- Investigators
- Laura Ceballos, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743219
- Sponsor's protocol ID
- 0212202023220
- Status last verified
- Nov 2022
- First submitted
- 1 Feb 2021
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Terceno P, Olivieri JG, Fuentes V, Ceballos L. Calcium silicate liner versus no liner in selective caries removal: a one-year randomized clinical trial. BMC Oral Health. 2026 Feb 26;26(1):572. doi: 10.1186/s12903-026-07823-8.
PubMed 41742170
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Removal Technique With or Without the Use of a Bioactive Material for the Management of Deep Caries Lesions in Permanent Posterior Teeth With Close Apex. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04743219
- Acronym / sponsor ID
- 0212202023220
- Conditions
- Deep Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 8 Feb 2021 (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.
Objectives: To evaluate and compare clinical and radiographic success of the selective removal to soft dentine technique in one step using calcium silicate cement (Biodentine) vs. no indirect pulp capping material in patients with deep caries lesions in mature permanent posterior teeth with normal or reversible pulpitis after a 2 year follow-up. Evaluate the integrity of the resin composite restorations using FDI criteria.
Material and methods: selective removal to soft dentine in one visit will be performed in 104 blinded patients that will be randomly allocated into 2 study arms, 52 patients will constitute the Biodentine group and 52 the No material group. Clinical examination will be performed to obtain pre-, intra- and postoperative data, including vitality test results, periapical status and risk of caries of the patients. Periapical and bitewing radiographs will be taken before treatment (T-0), at 1 month (T-1), 6 months (T-2), 12 months (T-3) and 24 months (T-4). Restorations will be assessed using the FDI criteria at the same follow up periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Biodentine Group | Active comparator | Procedure: Selective removal to soft dentin, BiodentineBiodentine group: patients with mature permanent posterior teeth with deep caries lesions treated with the selective removal technique to soft dentin with Biodentine as indirect pulp capping material before placement of a definitive direct composite resin restoration. |
| No base Group | Experimental | Procedure: Selective removal to soft dentin, No BaseThe experimental group or No Base group: patients with mature permanent posterior teeth with deep caries lesions treated with the selective removal technique to soft dentin without the placement of a bioactive material as a base and restored directly with a definitive direct composite resin restoration. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients older than 15 years.
- Parents or guardians of patients under 18 years of age, but over 15 years of age, and patients over 18 years of age who demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and who receive a signed and dated copy of the informed consent form.
- Occlusal or occlusal-proximal caries lesions, Class I or Class II, in molars or premolars with enamel margins and affecting maximum one proximal wall.
- Molar or premolar with deep caries lesion, involving equal to or greater than two thirds of dentin in depth, with a radiographically identifiable band of healthy dentin separating the pulp chamber roof from the caries lesion.
- Normal response to tests of sensitivity (normal pulp) or discomfort when cold stimulus is applied that disappears in a couple of seconds after the elimination of the stimulus (reversible pulpitits).
Key exclusion criteria (11 listed)
- Patients immunosuppressed or with severe systemic diseases.
- Teeth with root or cervical resorption.
- Teeth with obliteration of the pulp chamber.
- Periapical or furcal radiolucency.
- Patients with periodontal disease.
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 |
|---|---|---|
| Selective removal to soft dentin, BiodentineCarious tissue removed until its complete elimination from the lateral walls of the cavity using a round tungsten carbide bur at low speed until consistency of hard dentin around perimeter. With a manual excavator, the central cariogenic biomass will be removed, specifically the superficial part of the necrotic and demineralized caries dentin. In the Biodentine group, Biodentine (Septodont) will be placed on the base of the cavity with a thickness of 2 mm. The last step will be to perform a definitive direct resin restoration according to clinical indication. | Procedure or surgery | Biodentine Group |
| Selective removal to soft dentin, No BaseCarious tissue removed until its complete elimination from the lateral walls of the cavity using a round tungsten carbide bur at low speed until consistency of hard dentin around perimeter. With a manual excavator, the central cariogenic biomass will be removed, specifically the superficial part of the necrotic and demineralized caries dentin. In the No base group, no bioactive material will be placed as a liner, the 3M Scothcbonf Universal Plus adhesive will be placed directly over the remaining dentin surface. The last step will be to perform a definitive direct resin restoration according to clinical indication. | Procedure or surgery | No base Group |
Primary outcome
Clinical success
Time frame: 2 years
Clinical success is defined as healthy pulp, determined by a normal positive not prolonged response in the clinical examination to the cold test and the electrical test, negative response to percussion, absence of symptoms or signs of infection (abscess, fistula, swelling or inflammation) and absence of spontaneous pain.
1 secondary outcome
Radiographic success
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Derived from this study: PubMed 41742170Terceno P, Olivieri JG, Fuentes V, Ceballos L. Calcium silicate liner versus no liner in selective caries removal: a one-year randomized clinical trial. BMC Oral Health. 2026 Feb 26;26(1):572. doi: 10.1186/s12903-026-07823-8.
- 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.
Laura Ceballos study director
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective removal to soft dentin, Biodentine and Selective removal to soft dentin, No Base in people with Deep Caries, run by Universidad Rey Juan Carlos 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 6 inclusion and 11 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 21 Nov 2022. 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?
Contact Patricia Terceño (659053538, ptercenojimenez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743219, which also lists 1 linked publication.
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 21 Nov 2022.