NCT04743219

Selective Removal Technique With or Without a Bioactive Material for Deep Caries Lesions

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Universidad Rey Juan Carlos · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Accepted

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. 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

Interventions

Type	Name	Description
PROCEDURE	Selective removal to soft dentin, Biodentine	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.
PROCEDURE	Selective removal to soft dentin, No Base	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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2025-03-01
• Completion: 2025-04-01
• First posted: 2021-02-08
• Last updated: 2022-11-21

Locations

1 site across 1 country: Spain