CariesPhase 2/3NCT02492841
Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth
A Phase 2/3 study testing Mineral trioxide aggregate, Calcium hydroxide and Biodentine in people with Caries and Dental Pulp Exposure, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental Pulp Exposure
- What is being tested?
- Mineral trioxide aggregate, Calcium hydroxide and Biodentine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteChile
- Study dates
- Apr 2014to Aug 2016
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Systemically healthy patients
- Patients with at least one full or partial tooth root development
- Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis
- Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration
- Teeth that have pulp exposure not exceeding 1 mm in size.
Who cannot join
- Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic
- Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Clinical Trial of the Effect of Calcium Hydroxide, Mineral Trioxide Aggregate (MTA) and Biodentine (Trademark) as Direct Pulp Capping Materials of Permanent Teeth Affected by Caries, in Children From 7 to 16 Years
Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation.
Objective: The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.
Read the detailed description
Methodology: It is a randomized controlled study. groups signed the informed consent for clinical trial patients, a clinical evaluation of 90 permanent molars teeth through endodontic diagnostic tests and radiograph. will be conducted to determine diagnosis. Will be assigned randomly to the type of material to use and direct pulp teeth affected by caries coating is carried out; Patients will not have knowledge of the material to be used in the coating. The patient will be clinically evaluated at 1 week, 3 months and 8 months, and radiographically; at the beginning and end of the study. In each clinical control endodontic diagnostic tests of heat, cold, electric and percussion will be performed. In radiographic controls take a radiograph control with positioner or surveyor at baseline and 8 months, to evaluate the periapical status. Clinical success will consider that tooth in continuous controls and after 8 months presented vitality and radiographic signs of apical image without injury. Failure unresponsive to consider whether susceptibility testing of cold and electricity in more than one control and presents radiographic image with apical lesion.
- Conditions
- Caries, Dental Pulp Exposure
- Being tested
- Mineral trioxide aggregate, Calcium hydroxide, Biodentine
- Keywords
- dentin substitute, vital pulp therapy, Biodentine, caries
- Medical subject headings
- Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral trioxide aggregateDrug
Also called MTA Pro Root
Mineral trioxide aggregate
Calcium hydroxideDrug
Also called Calcium hydroxide Hertz
Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
BiodentineDrug
Also called Active biosilicate. Septodont.
Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
| Study group | Role | What they receive |
|---|---|---|
| Mineral trioxide aggregate (MTA) | Experimental | Mineral trioxide aggregate Root canal repair material Receives: Drug: Mineral trioxide aggregate |
| Calcium hydroxide | Active comparator | -material for pulp capping Receives: Drug: Calcium hydroxide |
| Biodentine | Experimental | Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping Receives: Drug: Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters Evaluated After Treatment
vitality test with electric device cold and hot test radiographic evaluation
Measured: 3 months, 6 moths and 12 months
Secondary outcomes (1)
Number of Participants With Adverse Effects
Name any adverse effects caused by treatment.
Measured: 1 week, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dra. Claudia Brizuel, Universidad de los Andes, Chile
- Investigators
- Claudia Brizuela, Principal investigator, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492841
- Sponsor's protocol ID
- RPD-7-16
- Other IDs
- SA13I20175
- Status last verified
- May 2024
- First submitted
- 27 May 2015
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paranjpe A, Zhang H, Johnson JD. Effects of mineral trioxide aggregate on human dental pulp cells after pulp-capping procedures. J Endod. 2010 Jun;36(6):1042-7. doi: 10.1016/j.joen.2010.02.013. Epub 2010 Mar 15.
PubMed 20478462Leye Benoist F, Gaye Ndiaye F, Kane AW, Benoist HM, Farge P. Evaluation of mineral trioxide aggregate (MTA) versus calcium hydroxide cement (Dycal((R)) ) in the formation of a dentine bridge: a randomised controlled trial. Int Dent J. 2012 Feb;62(1):33-9. doi: 10.1111/j.1875-595X.2011.00084.x.
PubMed 22251035Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10.
PubMed 23683272
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Clinical Trial of the Effect of Calcium Hydroxide, Mineral Trioxide Aggregate (MTA) and Biodentine (Trademark) as Direct Pulp Capping Materials of Permanent Teeth Affected by Caries, in Children From 7 to 16 Years
- ClinicalTrials.gov ID
- NCT02492841
- Acronym / sponsor ID
- RPD-7-16
- Conditions
- Caries, Dental Pulp Exposure
- Keywords
- dentin substitute, vital pulp therapy, Biodentine, caries
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Posted 14 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation.
Objective: The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.
Detailed description
Methodology: It is a randomized controlled study. groups signed the informed consent for clinical trial patients, a clinical evaluation of 90 permanent molars teeth through endodontic diagnostic tests and radiograph. will be conducted to determine diagnosis. Will be assigned randomly to the type of material to use and direct pulp teeth affected by caries coating is carried out; Patients will not have knowledge of the material to be used in the coating. The patient will be clinically evaluated at 1 week, 3 months and 8 months, and radiographically; at the beginning and end of the study. In each clinical control endodontic diagnostic tests of heat, cold, electric and percussion will be performed. In radiographic controls take a radiograph control with positioner or surveyor at baseline and 8 months, to evaluate the periapical status. Clinical success will consider that tooth in continuous controls and after 8 months presented vitality and radiographic signs of apical image without injury. Failure unresponsive to consider whether susceptibility testing of cold and electricity in more than one control and presents radiographic image with apical lesion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mineral trioxide aggregate (MTA) | Experimental | Drug: Mineral trioxide aggregateMineral trioxide aggregate Root canal repair material |
| Calcium hydroxide | Active comparator | Drug: Calcium hydroxide-material for pulp capping |
| Biodentine | Experimental | Drug: BiodentineIs a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Systemically healthy patients
- Patients with at least one full or partial tooth root development
- Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis
- Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration
- Teeth that have pulp exposure not exceeding 1 mm in size.
Key exclusion criteria (2 listed)
- Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic
- Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .
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 |
|---|---|---|
| Mineral trioxide aggregateAlso: MTA Pro RootMineral trioxide aggregate | Drug | Mineral trioxide aggregate (MTA) |
| Calcium hydroxideAlso: Calcium hydroxide HertzClassic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material. | Drug | Calcium hydroxide |
| BiodentineAlso: Active biosilicate. Septodont.Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution. | Drug | Biodentine |
Primary outcome
Parameters Evaluated After Treatment
Time frame: 3 months, 6 moths and 12 months
vitality test with electric device cold and hot test radiographic evaluation
1 secondary outcome
Number of Participants With Adverse Effects
Time frame: 1 week, 3 and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20478462Paranjpe A, Zhang H, Johnson JD. Effects of mineral trioxide aggregate on human dental pulp cells after pulp-capping procedures. J Endod. 2010 Jun;36(6):1042-7. doi: 10.1016/j.joen.2010.02.013. Epub 2010 Mar 15.
- Background: PubMed 22251035Leye Benoist F, Gaye Ndiaye F, Kane AW, Benoist HM, Farge P. Evaluation of mineral trioxide aggregate (MTA) versus calcium hydroxide cement (Dycal((R)) ) in the formation of a dentine bridge: a randomised controlled trial. Int Dent J. 2012 Feb;62(1):33-9. doi: 10.1111/j.1875-595X.2011.00084.x.
- Background: PubMed 23683272Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10.
- Individual participant dataSharing planned: No
Related trials for Caries
Active, not recruiting
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
Caries, Defective Restorations
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruitingObservational study
Diagnostic Performance of Ai vs Junior Dentists
Diagnosis
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
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.
Claudia Brizuela principal investigator
Universidad de los Andes, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mineral trioxide aggregate, Calcium hydroxide and Biodentine in people with Caries and Dental Pulp Exposure, run by Universidad de los Andes, Chile at 1 site in Chile.
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 5 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: finished, as of the sponsor's last update on 30 May 2024. 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 Chile. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Parameters Evaluated After Treatment (time frame: 3 months, 6 moths and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02492841, which also lists 3 linked publications.
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 30 May 2024.