Status:
UNKNOWN
Selective Removal Technique With or Without a Bioactive Material for Deep Caries Lesions
Lead Sponsor:
Universidad Rey Juan Carlos
Conditions:
Deep Caries
Eligibility:
All Genders
15-65 years
Phase:
NA
Brief 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 cap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04743219
Start Date
February 1 2021
End Date
April 1 2025
Last Update
November 21 2022
Active Locations (1)
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1
Universidad Rey Juan Carlos
Alcorcón, Madrid, Spain, 28922