Selective Removal Technique With or Without a Bioactive Material for Deep Caries Lesions
NCT ID: NCT04743219
Last Updated: 2022-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
104 participants
INTERVENTIONAL
2021-02-01
2025-04-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Biodentine Group
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.
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.
No base Group
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
15 Years
65 Years
ALL
Yes
Sponsors
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Universidad Rey Juan Carlos
OTHER
Responsible Party
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Patricia Terceño Jiménez
DDS, MS
Principal Investigators
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Laura Ceballos
Role: STUDY_DIRECTOR
Universidad Rey Juan Carlos
Locations
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Universidad Rey Juan Carlos
Alcorcón, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0212202023220
Identifier Type: -
Identifier Source: org_study_id
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