Clinical trial NCT04743219: Selective Removal Technique With or Without a Bioactive Material for Deep Caries Lesions
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Caries
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 104
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical success
timeFrame: 2 years
Secondary outcomes:
measure: Radiographic success
timeFrame: 2 years
Other outcomes:
measure: Failure composite resin restorations
timeFrame: 2 years
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Laura Ceballos
role: STUDY_DIRECTOR
References: