Dental CariesNCT04533113
Carious Tissue Selective Removal on Permanent Posterior Teeth.
A study testing Carious tissue selective removal in people with Dental Caries and Dental Materials, run by Juan Gonzalo Olivieri at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Materials
- What is being tested?
- Carious tissue selective removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteSpain
- Study dates
- 20 Feb 2019to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Juan G. Olivieri, DDS, PhD, 935042000, jgolivieri@uic.es
About this study
Official title: 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.
- Conditions
- Dental Caries, Dental Materials
- Being tested
- Carious tissue selective removal
- Keywords
- Dental caries, Dental materials, Outcome, Postoperative Pain
- Medical subject headings
- Dental Caries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carious tissue selective removalProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| VitreBond LC | Experimental | VitreBond LC used as a liner after selective carious tissue removal. Receives: Procedure: Carious tissue selective removal |
| Biodentine | Experimental | Biodentine used as a liner after selective carious tissue removal. Receives: Procedure: Carious tissue selective removal |
| Theracal | Experimental | Theracal used as a liner after selective carious tissue removal. Receives: Procedure: Carious tissue selective removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Measured: Immediately post-treatment
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Measured: 8 hours post-treatment
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Measured: 24 hours post-treatment
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Measured: 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
Measured: 1 year
Clinical signs or symptoms of pulp or periapical disease
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Measured: 2 years
Clinical signs or symptoms of pulp or periapical disease
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Measured: 5 years
Radiographic signs of periapical disease
Absence/presence of radiographic apical periodontitis
Measured: 1 year
Radiographic signs of periapical disease
Absence/presence of radiographic apical periodontitis
Measured: 2 years
Radiographic signs of periapical disease
Absence/presence of radiographic apical periodontitis
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start20 Feb 2019
- Primary completionJul 2021 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Gonzalo Olivieri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Gonzalo Olivieri, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533113
- Sponsor's protocol ID
- ENDECL201804
- Status last verified
- Aug 2020
- First submitted
- 27 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carious Tissue Selective Removal on Permanent Posterior Teeth. A Randomized Controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT04533113
- Acronym / sponsor ID
- ENDECL201804
- Conditions
- Dental Caries, Dental Materials
- Keywords
- Dental caries, Dental materials, Outcome, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Juan Gonzalo OlivieriUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VitreBond LC | Experimental | Procedure: Carious tissue selective removalVitreBond LC used as a liner after selective carious tissue removal. |
| Biodentine | Experimental | Procedure: Carious tissue selective removalBiodentine used as a liner after selective carious tissue removal. |
| Theracal | Experimental | Procedure: Carious tissue selective removalTheracal used as a liner after selective carious tissue removal. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carious tissue selective removalCarious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration | Procedure or surgery | Biodentine, Theracal, VitreBond LC |
Primary outcome
Clinical post-operative pain
Time frame: Immediately post-treatment
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
Time frame: 8 hours post-treatment
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
Time frame: 24 hours post-treatment
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
Time frame: 48 hours post-treatment
VAS score of patient' level of pain, from no pain to extreme pain
Clinical signs or symptoms of pulp or periapical disease
Time frame: 1 year
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Clinical signs or symptoms of pulp or periapical disease
Time frame: 2 years
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Clinical signs or symptoms of pulp or periapical disease
Time frame: 5 years
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Radiographic signs of periapical disease
Time frame: 1 year
Absence/presence of radiographic apical periodontitis
Radiographic signs of periapical disease
Time frame: 2 years
Absence/presence of radiographic apical periodontitis
Radiographic signs of periapical disease
Time frame: 4 years
Absence/presence of radiographic apical periodontitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carious tissue selective removal in people with Dental Caries and Dental Materials, run by Juan Gonzalo Olivieri at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical post-operative pain (time frame: Immediately post-treatment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.