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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    104
  • sponsor
    Universidad Rey Juan Carlos
Updated on 17 February 2021

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.

Details
Condition Deep Caries
Treatment Selective removal to soft dentin, Biodentine, Selective removal to soft dentin, No Base
Clinical Study IdentifierNCT04743219
SponsorUniversidad Rey Juan Carlos
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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