Carious Tissue Selective Removal on Permanent Posterior Teeth.

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04533113
• Other study ID #: ENDECL201804
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: July 2026

Study information

• Verified date: August 2020
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: July 2026
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Materials

Intervention

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

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat Del Vallès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Juan Gonzalo Olivieri

Country where clinical trial is conducted

Spain, 

Outcome

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