Carious Tissue Selective Removal on Permanent Posterior Teeth.

Not Applicable

Recruiting

• Conditions: Dental Materials; Dental Caries
• Interventions: Procedure: Carious tissue selective removal

• Registration Number: NCT04533113
• Lead Sponsor: Juan Gonzalo Olivieri

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-20
• Status Verified: 2020-08
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Last Update Submitted: 2020-08-27
• Study First Posted: 2020-08-31
• Last Update Posted: 2020-08-31
• Primary Completion: 2021-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VitreBond LC	Carious tissue selective removal	VitreBond LC used as a liner after selective carious tissue removal.
Biodentine	Carious tissue selective removal	Biodentine used as a liner after selective carious tissue removal.
Theracal	Carious tissue selective removal	Theracal used as a liner after selective carious tissue removal.

Primary Outcome Measures

Name	Time	Method
Clinical post-operative pain	48 hours post-treatment	VAS score of patient' level of pain, from no pain to extreme pain
Radiographic signs of periapical disease	4 years	Absence/presence of radiographic apical periodontitis
Clinical signs or symptoms of pulp or periapical disease	5 years	Absence/presence of clinical signs or symptoms of pulp or periapical disease

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat Del Vallès, Barcelona, Spain