Deep Carious LesionsNCT03741816
Indirect Pulp Capping With Biodentine and TheraCal LC in Permanent Mature Molars
A study testing Indirect pulp capping in people with Deep Carious Lesions and Reversible Pulpitis, run by University of Valencia at 1 site in Spain.
Trial summary
Management of deep carious lesions in permanent mature molars with reversible pulpitis represents a challenge for clinicians. Vital pulp therapy includes indirect and direct pulp capping, partial pulpotomy and full pulpotomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Deep Carious Lesions, Reversible Pulpitis, Indirect Pulp Capping
- What is being tested?
- Indirect pulp capping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2019to Jan 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years without any systemic disease.
- Presence of a deep carious lesion in a permanent mature molar without periapical pathology that penetrates radiographically into the inner dentin half or even third/ quarter.
- Preoperative diagnosis of reversible pulpitis.
- After selective caries removal to soft dentin with a high-speed diamond bur and Cariosolv gel and hand instruments, no pulpal exposure occurred.
Who cannot join
- Negative response to pulp sensibility tests.
- Clinical symptoms of irreversible pulpitis or pulp necrosis.
- Presence of fistula, swelling, tenderness to percussion, tooth mobility.
- Presence of periapical pathology on periapical radiographs (internal or external root resorption, abscence of normal appearance of periodontal ligament, presence of interradicular or periapical radiolucencies).
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Blind Clinical Trial, Two-armed, Parallel of Indirect Pulp Capping With Biodentine and TheraCal LC in Permanent Mature Molars With Deep Carious Lesions
Management of deep carious lesions in permanent mature molars with reversible pulpitis represents a challenge for clinicians. Vital pulp therapy includes indirect and direct pulp capping, partial pulpotomy and full pulpotomy. Indirect pulp capping is a procedure in which a material is placed on a thin layer of remaining soft dentin that, if removed, might expose the pulp. The objective is dentin bridge formation and pulp vitality preservation.
The aim of this randomized clinical trial is to evaluate the success rate of indirect pulp capping with Biodentine and TheraCal LC in mature permanent molars with deep carious lesions at one-year follow-up examination. The null hypothesis tested will be that there is no statistically significant difference in success rate between both materials in indirect pulp capping of permanent mature molars with deep carious lesions.
Read the detailed description
Treatment options for permanent mature molars with deep carious lesions and a preoperative diagnosis of reversible pulpitis are varied among clinicians. In the last few years, a more biological approach is arising interest in the field of Endodontics through the development of calcium-silicate based cements that are used in vital pulp therapy.
A great variety of materials have been employed for indirect pulp capping. Although calcium hydroxide has been the "gold standard" for decades for this procedure, nowadays calcium-silicate based cements such as Mineral Trioxide Aggregate (MTA) are preferred. The second generation of these cements, among which Biodentine (Septodont, Saint Maur-des-Fossés, France) and TheraCal LC (Bisco, Schaumburg, IL, USA) stand out, try to overcome the first generation limitations.
On the other hand, there is a paradigm shift in caries removal techniques. Nowadays, the non-selective technique is not longer recommended and a selective removal technique until soft dentin is preferred in deep cavitated lesions.
The study will be carried out at the dental clinic of the Master of Restorative Dentistry and Endodontics (Medical and Dental School) of University of Valencia (Spain).
The study protocol that will be followed is:
- Sample size estimation: 212 participants (106 per group).
- Informed written consent will be obtained from all participants.
- A full dental and medical history will be obtained from all patients.
- Clinical (thermal and electric pulp tests, and palpation and percussion) and a radiographic examination (periapical radiograph and a small-volume cone beam computed tomography (CBCT).
- Anesthesia administration and rubber dam placement.
- Selective caries removal technique with high-speed diamond burs with air/water spray for enamel and Cariosolv gel and hand instruments until soft dentin.
- Allocation to one of the two groups: Biodentine (control) or TheraCal LC (experimental) for indirect pulp capping procedures.
- Final direct composite restoration using the selective etching technique and an universal adhesive.
- Baseline periapical radiograph.
- Follow-up: clinical and radiographic follow-up examinations will be conducted at one month, six months and twelve months (±2 weeks). In the one-year follow-up examination, a small-volume CBCT will be taken.
- Being tested
- Indirect pulp capping
- Keywords
- permanent molars, indirect pulp capping, reversible pulpitis, deep carious lesions, Biodentine, TheraCal LC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect pulp cappingDrug
Indirect pulp capping is a procedure in which a material is placed on a thin partition of remaining carious dentin that, if removed might expose the pulp.
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Active comparator | Indirect pulp capping with Biodentine in mature permanent molars with deep carious lesions and reversible pulpitis Receives: Drug: Indirect pulp capping |
| TheraCal LC | Experimental | Indirect pulp capping with TheraCal LC in mature permanent molars with deep carious lesions and reversible pulpitis Receives: Drug: Indirect pulp capping |
What is being measured
The primary outcome is the main question the study is designed to answer.
response to pulp sensibility testing ( thermal and electric pulp testing)
abscence of clinical signs and/or symptoms and radiographic findings of pulp degeneration
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start7 Jan 2019
- Primary completionJan 2020 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Carious LesionsStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Pasarín Linares, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741816
- Sponsor's protocol ID
- 1/2018
- Status last verified
- Jan 2019
- First submitted
- 12 Nov 2018
- Last updated
- 8 Jan 2019
- 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 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Blind Clinical Trial, Two-armed, Parallel of Indirect Pulp Capping With Biodentine and TheraCal LC in Permanent Mature Molars With Deep Carious Lesions
- ClinicalTrials.gov ID
- NCT03741816
- Acronym / sponsor ID
- 1/2018
- Keywords
- permanent molars, indirect pulp capping, reversible pulpitis, deep carious lesions, Biodentine, TheraCal LC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 15 Nov 2018 (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.
Management of deep carious lesions in permanent mature molars with reversible pulpitis represents a challenge for clinicians. Vital pulp therapy includes indirect and direct pulp capping, partial pulpotomy and full pulpotomy. Indirect pulp capping is a procedure in which a material is placed on a thin layer of remaining soft dentin that, if removed, might expose the pulp. The objective is dentin bridge formation and pulp vitality preservation.
The aim of this randomized clinical trial is to evaluate the success rate of indirect pulp capping with Biodentine and TheraCal LC in mature permanent molars with deep carious lesions at one-year follow-up examination. The null hypothesis tested will be that there is no statistically significant difference in success rate between both materials in indirect pulp capping of permanent mature molars with deep carious lesions.
Detailed description
Treatment options for permanent mature molars with deep carious lesions and a preoperative diagnosis of reversible pulpitis are varied among clinicians. In the last few years, a more biological approach is arising interest in the field of Endodontics through the development of calcium-silicate based cements that are used in vital pulp therapy.
A great variety of materials have been employed for indirect pulp capping. Although calcium hydroxide has been the "gold standard" for decades for this procedure, nowadays calcium-silicate based cements such as Mineral Trioxide Aggregate (MTA) are preferred. The second generation of these cements, among which Biodentine (Septodont, Saint Maur-des-Fossés, France) and TheraCal LC (Bisco, Schaumburg, IL, USA) stand out, try to overcome the first generation limitations.
On the other hand, there is a paradigm shift in caries removal techniques. Nowadays, the non-selective technique is not longer recommended and a selective removal technique until soft dentin is preferred in deep cavitated lesions.
The study will be carried out at the dental clinic of the Master of Restorative Dentistry and Endodontics (Medical and Dental School) of University of Valencia (Spain).
The study protocol that will be followed is:
- Sample size estimation: 212 participants (106 per group).
- Informed written consent will be obtained from all participants.
- A full dental and medical history will be obtained from all patients.
- Clinical (thermal and electric pulp tests, and palpation and percussion) and a radiographic examination (periapical radiograph and a small-volume cone beam computed tomography (CBCT).
- Anesthesia administration and rubber dam placement.
- Selective caries removal technique with high-speed diamond burs with air/water spray for enamel and Cariosolv gel and hand instruments until soft dentin.
- Allocation to one of the two groups: Biodentine (control) or TheraCal LC (experimental) for indirect pulp capping procedures.
- Final direct composite restoration using the selective etching technique and an universal adhesive.
- Baseline periapical radiograph.
- Follow-up: clinical and radiographic follow-up examinations will be conducted at one month, six months and twelve months (±2 weeks). In the one-year follow-up examination, a small-volume CBCT will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Active comparator | Drug: Indirect pulp cappingIndirect pulp capping with Biodentine in mature permanent molars with deep carious lesions and reversible pulpitis |
| TheraCal LC | Experimental | Drug: Indirect pulp cappingIndirect pulp capping with TheraCal LC in mature permanent molars with deep carious lesions and reversible pulpitis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient ≥ 18 years without any systemic disease.
- Presence of a deep carious lesion in a permanent mature molar without periapical pathology that penetrates radiographically into the inner dentin half or even third/ quarter.
- Preoperative diagnosis of reversible pulpitis.
- After selective caries removal to soft dentin with a high-speed diamond bur and Cariosolv gel and hand instruments, no pulpal exposure occurred.
Key exclusion criteria (5 listed)
- Negative response to pulp sensibility tests.
- Clinical symptoms of irreversible pulpitis or pulp necrosis.
- Presence of fistula, swelling, tenderness to percussion, tooth mobility.
- Presence of periapical pathology on periapical radiographs (internal or external root resorption, abscence of normal appearance of periodontal ligament, presence of interradicular or periapical radiolucencies).
- Pregnant women.
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 |
|---|---|---|
| Indirect pulp cappingIndirect pulp capping is a procedure in which a material is placed on a thin partition of remaining carious dentin that, if removed might expose the pulp. | Drug | Biodentine, TheraCal LC |
Primary outcome
response to pulp sensibility testing ( thermal and electric pulp testing)
Time frame: one year
abscence of clinical signs and/or symptoms and radiographic findings of pulp degeneration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Deep Carious Lesions
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Pulp Inflammatory Markers and Outcome of Pulpotomy
Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp
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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 Indirect pulp capping in people with Deep Carious Lesions and Reversible Pulpitis, run by University of Valencia 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 4 inclusion and 5 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 8 Jan 2019. 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?
Contact Cristina Pasarín Linares (+ 34 630493515, cpasarinlinares@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response to pulp sensibility testing ( thermal and electric pulp testing) (time frame: one year). 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 8 Jan 2019.