Dental Caries in ChildrenVITAPULPNCT03626740
Experimental Research on Deep Carious Lesion Treatment of Molars
A study testing TheraCal and MTA in people with Dental Caries in Children, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Maintaining dental pulp vitality is crucial for tooth preservation and functionality. Untreated dental caries may lead to pulp necrosis and infection, affecting children's growth and well-being. The first permanent teeth erupt around 6 years old. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- TheraCal and MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRomania
- Study dates
- 8 Jan 2018to 4 Oct 2020
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- untreated deep uncomplicated carious lesions in first permanent molars (FPM)
- absence of clinical diagnosis of pulp exposure
- fistula
- swelling of periodontal tissues
- abnormal tooth mobility
- history of spontaneous pain or sensitivity to percussion
Show all 9Show fewer
- healthy appearance of adjacent gingiva
- normal tooth color
- positive vitality to thermal and electric tests.
Who cannot join
- FPM with previous treatment
- FPM with developmental abnormalities (such as enamel hypoplasia, dentinogenesis imperfecta etc.)
- children with mental disabilities or systemic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experimental Research on Deep Carious Lesion Treatment of Permanent Molars in Children, Aiming to Preserve Dental Pulp Vitality
Maintaining dental pulp vitality is crucial for tooth preservation and functionality. Untreated dental caries may lead to pulp necrosis and infection, affecting children's growth and well-being. The first permanent teeth erupt around 6 years old. These are the first molars (FPM), which are frequently affected by caries, soon after their eruption.
In the present application, our main goal is to determine whether two treatment groups (MTA and TheraCal) are long-term effective in preserving pulp vitality among children' FPM affected by deep caries.
Read the detailed description
Among the most frequently used materials for pulp capping are calcium hydroxide, mineral trioxide aggregate (MTA), and, more recent, TheraCal. All of them are biocompatible and induce the formation of coronal hard tissue barriers (tertiary reparative dentin). Calcium hydroxide, considered for a long time the gold standard of direct pulp capping materials, has excellent antibacterial and remineralisant properties; however, it lacks adhesion, especially at moist dentin, and reparative dentin is less homogenous.
MTA proved to stimulate protective dentin bridge formation without inflammatory changes and least necrosis. It is also moisture tolerant, but it is more expensive, has poor handling characteristics and slow setting time.
TheraCal bonds to deep moist dentin, has strong physical properties, no solubility, high radioopacity and higher calcium releasing abilities than MTA or calcium hydroxide.
- Conditions
- Dental Caries in Children
- Being tested
- TheraCal, MTA
- Keywords
- dental pulp, deep carious lesions, treatment effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraCalOther
Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with TheraCal
MTAOther
Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA
| Study group | Role | What they receive |
|---|---|---|
| TheraCal | Experimental | Indirect pulp capping with TheraCal Receives: Other: TheraCal |
| Mineral trioxide aggregate (MTA) | Active comparator | Indirect pulp capping with MTA Receives: Other: MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pulpal survival rate
Pulpal survival is defined by positive response without lingering sensation to the cold test, absence of clinical signs and symptoms, and no apical radiolucency on the periapical radiograph.
Measured: 20 months
Secondary outcomes (1)
Incidence of apical root maturation (apexogenesis)
We will investigate the treatment effect on apexogenesis in children who had incomplete root formation at the beginning of the study and preserve their pulp vitality at the end of the study. The outcome will be compared radiographically with apical maturation in molar pairs (healthy contralateral molar, where applicable).
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start8 Jan 2018
- Primary completion30 Jun 2020
- Study completion4 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreea Didilescu, DDS, Carol Davila University of Medicine and Pharmacy
- Investigators
- Andreea C Didilescu, DDS, PhD, Principal investigator, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626740
- Sponsor's protocol ID
- PN-III-P4-ID-PCE-2016-0506
- Acronym
- VITAPULP
- Status last verified
- Aug 2021
- First submitted
- 1 Aug 2018
- Last updated
- 6 Aug 2021
- 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 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Research on Deep Carious Lesion Treatment of Permanent Molars in Children, Aiming to Preserve Dental Pulp Vitality
- ClinicalTrials.gov ID
- NCT03626740
- Acronym / sponsor ID
- VITAPULP / PN-III-P4-ID-PCE-2016-0506
- Conditions
- Dental Caries in Children
- Keywords
- dental pulp, deep carious lesions, treatment effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 4 Oct 2020 (actual)
- First posted
- 13 Aug 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.
Maintaining dental pulp vitality is crucial for tooth preservation and functionality. Untreated dental caries may lead to pulp necrosis and infection, affecting children's growth and well-being. The first permanent teeth erupt around 6 years old. These are the first molars (FPM), which are frequently affected by caries, soon after their eruption.
In the present application, our main goal is to determine whether two treatment groups (MTA and TheraCal) are long-term effective in preserving pulp vitality among children' FPM affected by deep caries.
Detailed description
Among the most frequently used materials for pulp capping are calcium hydroxide, mineral trioxide aggregate (MTA), and, more recent, TheraCal. All of them are biocompatible and induce the formation of coronal hard tissue barriers (tertiary reparative dentin). Calcium hydroxide, considered for a long time the gold standard of direct pulp capping materials, has excellent antibacterial and remineralisant properties; however, it lacks adhesion, especially at moist dentin, and reparative dentin is less homogenous.
MTA proved to stimulate protective dentin bridge formation without inflammatory changes and least necrosis. It is also moisture tolerant, but it is more expensive, has poor handling characteristics and slow setting time.
TheraCal bonds to deep moist dentin, has strong physical properties, no solubility, high radioopacity and higher calcium releasing abilities than MTA or calcium hydroxide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TheraCal | Experimental | Other: TheraCalIndirect pulp capping with TheraCal |
| Mineral trioxide aggregate (MTA) | Active comparator | Other: MTAIndirect pulp capping with MTA |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- untreated deep uncomplicated carious lesions in first permanent molars (FPM)
- absence of clinical diagnosis of pulp exposure
- fistula
- swelling of periodontal tissues
- abnormal tooth mobility
Key exclusion criteria (3 listed)
- FPM with previous treatment
- FPM with developmental abnormalities (such as enamel hypoplasia, dentinogenesis imperfecta etc.)
- children with mental disabilities or systemic diseases.
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 |
|---|---|---|
| TheraCalCaries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with TheraCal | Other | TheraCal |
| MTACaries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA | Other | Mineral trioxide aggregate (MTA) |
Primary outcome
Clinical pulpal survival rate
Time frame: 20 months
Pulpal survival is defined by positive response without lingering sensation to the cold test, absence of clinical signs and symptoms, and no apical radiolucency on the periapical radiograph.
1 secondary outcome
Incidence of apical root maturation (apexogenesis)
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- 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.
Andreea C Didilescu, DDS, PhD principal investigator
Carol Davila University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraCal and MTA in people with Dental Caries in Children, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
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 9 inclusion and 3 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: finished, as of the sponsor's last update on 6 Aug 2021. 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 Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pulpal survival rate (time frame: 20 months). 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 6 Aug 2021.