Carious Tissue Selective Removal on Permanent Posterior Teeth.

Carious Tissue Selective Removal on Permanent Posterior Teeth. A Randomized Controlled Clinical Study.

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04533113

Enrollment

111

Registered

2020-08-31

Start date

2019-02-20

Completion date

2026-07-31

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Dental Materials

Keywords

Dental caries, Dental materials, Outcome, Postoperative Pain

Brief summary

This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of selective removal of carious tissue in deep lesions of posterior teeth. Three different materials will be used as liners (VitreBond ™Plus, BioDentine™, and Theracal™ LC). Post-operative pain, clinical, and radiographic success will be evaluated at one, two, and five-year follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment with the three materials used.

Interventions

PROCEDURECarious tissue selective removal

Carious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form. * Understands and is willing to comply with all study procedures and restrictions. * Not presence of clinically significant and relevant abnormalities of clinical history or oral examination. * Diagnosis of normal pulp or reversible pulpitis. * No presence of periapical periodontitis * Posterior teeth

Exclusion criteria

General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities. Specific: Impossibility of restoration, diagnosis of irreversible pulpitis or necrosis, preoperative pain

Design outcomes

Primary

Measure	Time frame	Description
Clinical post-operative pain	Immediately post-treatment	VAS score of patient' level of pain, from no pain to extreme pain
Clinical signs or symptoms of pulp or periapical disease	1 year	Absence/presence of clinical signs or symptoms of pulp or periapical disease
Radiographic signs of periapical disease	1 year	Absence/presence of radiographic apical periodontitis

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026