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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective removal to soft dentin, Biodentine | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Failure composite resin restorations | FDI criteria will be used to assess the integrity of the composite resin restorations,It will be considered a restoration failure when the restoration presents a property classified as clinically unsatisfactory or poor. Thus, body fracture or loss of restoration, damage to the margin, weak contact point or food impaction, marginal or large gap, secondary caries or if the patient is not satisfied. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Terceño | Contact | 659053538 | ptercenojimenez@gmail.com | |
| Laura Ceballos | Contact | 667056606 | laura.ceballos@urjc.es |
| Name | Affiliation | Role |
|---|---|---|
| Laura Ceballos | Universidad Rey Juan Carlos | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Rey Juan Carlos | Recruiting | Alcorcón | Madrid | 28922 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41742170 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 23, 2025 | |
| Reset | Oct 13, 2025 | |
| Release | Nov 17, 2025 | |
| Reset | Nov 24, 2025 | |
| Release | Nov 25, 2025 | |
| Reset | Dec 10, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 23, 2025 | Oct 13, 2025 | |||
| Nov 17, 2025 |
| ID | Term |
|---|---|
| C506393 | tricalcium silicate |
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Randomized clinical trial
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|
| Selective removal to soft dentin, No Base | Procedure | 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. |
|
| 2 years |
| 2 years |
| Nov 24, 2025 |
| Nov 25, 2025 | Dec 10, 2025 |