Back to resultsCarious Tissue Selective Removal on Permanent Posterior Teeth.
Primary Purpose
Dental Caries, Dental Materials
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Carious tissue selective removal
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, Dental materials, Outcome, Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Universitat Internacional de CatalunyaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
VitreBond LC
Biodentine
Theracal
Arm Description
VitreBond LC used as a liner after selective carious tissue removal.
Biodentine used as a liner after selective carious tissue removal.
Theracal used as a liner after selective carious tissue removal.
Outcomes
Primary Outcome Measures
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Clinical signs or symptoms of pulp or periapical disease
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Clinical signs or symptoms of pulp or periapical disease
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Clinical signs or symptoms of pulp or periapical disease
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Radiographic signs of periapical disease
Absence/presence of radiographic apical periodontitis
Radiographic signs of periapical disease
Absence/presence of radiographic apical periodontitis
Radiographic signs of periapical disease
Absence/presence of radiographic apical periodontitis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04533113
Brief Title
Carious Tissue Selective Removal on Permanent Posterior Teeth.
Official Title
Carious Tissue Selective Removal on Permanent Posterior Teeth. A Randomized Controlled Clinical Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan Gonzalo Olivieri
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Dental Materials
Keywords
Dental caries, Dental materials, Outcome, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VitreBond LC
Arm Type
Experimental
Arm Description
VitreBond LC used as a liner after selective carious tissue removal.
Arm Title
Biodentine
Arm Type
Experimental
Arm Description
Biodentine used as a liner after selective carious tissue removal.
Arm Title
Theracal
Arm Type
Experimental
Arm Description
Theracal used as a liner after selective carious tissue removal.
Intervention Type
Procedure
Intervention Name(s)
Carious tissue selective removal
Intervention Description
Carious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration
Primary Outcome Measure Information:
Title
Clinical post-operative pain
Description
VAS score of patient' level of pain, from no pain to extreme pain
Time Frame
Immediately post-treatment
Title
Clinical post-operative pain
Description
VAS score of patient' level of pain, from no pain to extreme pain
Time Frame
8 hours post-treatment
Title
Clinical post-operative pain
Description
VAS score of patient' level of pain, from no pain to extreme pain
Time Frame
24 hours post-treatment
Title
Clinical post-operative pain
Description
VAS score of patient' level of pain, from no pain to extreme pain
Time Frame
48 hours post-treatment
Title
Clinical signs or symptoms of pulp or periapical disease
Description
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Time Frame
1 year
Title
Clinical signs or symptoms of pulp or periapical disease
Description
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Time Frame
2 years
Title
Clinical signs or symptoms of pulp or periapical disease
Description
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Time Frame
5 years
Title
Radiographic signs of periapical disease
Description
Absence/presence of radiographic apical periodontitis
Time Frame
1 year
Title
Radiographic signs of periapical disease
Description
Absence/presence of radiographic apical periodontitis
Time Frame
2 years
Title
Radiographic signs of periapical disease
Description
Absence/presence of radiographic apical periodontitis
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan G. Olivieri, DDS, PhD
Phone
935042000
Email
jgolivieri@uic.es
12. IPD Sharing Statement
Plan to Share IPD
No
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Carious Tissue Selective Removal on Permanent Posterior Teeth.
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