Carious Tissue Selective Removal on Permanent Posterior Teeth.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries; Dental Materials
• Intervention / Treatment: Procedure: Carious tissue selective removal

• Study Type: Interventional
• Enrollment (Anticipated): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Cugat Del Vallès, Barcelona, Spain, 08195
      • Recruiting
      • Universitat Internacional de Catalunya
      • Contact: Juan G. Olivieri, DDS, PhD; Phone Number: 935042000; Email: jgolivieri@uic.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VitreBond LC; VitreBond LC used as a liner after selective carious tissue removal.	Procedure: Carious 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
Experimental: Biodentine; Biodentine used as a liner after selective carious tissue removal.	Procedure: Carious 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
Experimental: Theracal; Theracal used as a liner after selective carious tissue removal.	Procedure: Carious 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical post-operative pain	VAS score of patient' level of pain, from no pain to extreme pain	Immediately post-treatment
Clinical post-operative pain	VAS score of patient' level of pain, from no pain to extreme pain	8 hours post-treatment
Clinical post-operative pain	VAS score of patient' level of pain, from no pain to extreme pain	24 hours post-treatment
Clinical post-operative pain	VAS score of patient' level of pain, from no pain to extreme pain	48 hours post-treatment
Clinical signs or symptoms of pulp or periapical disease	Absence/presence of clinical signs or symptoms of pulp or periapical disease	1 year
Clinical signs or symptoms of pulp or periapical disease	Absence/presence of clinical signs or symptoms of pulp or periapical disease	2 years
Clinical signs or symptoms of pulp or periapical disease	Absence/presence of clinical signs or symptoms of pulp or periapical disease	5 years
Radiographic signs of periapical disease	Absence/presence of radiographic apical periodontitis	1 year
Radiographic signs of periapical disease	Absence/presence of radiographic apical periodontitis	2 years
Radiographic signs of periapical disease	Absence/presence of radiographic apical periodontitis	4 years

Collaborators and Investigators

• Sponsor: Juan Gonzalo Olivieri

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2026

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative Pain; Outcome; Dental caries; Dental materials
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: ENDECL201804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No