Primary Molar PulpotomyPhase 4NCT01591278
MTA and Biodentine in Pulpotomized Primary Molars
A Phase 4 study testing Pulpotomy in people with Primary Molar Pulpotomy, run by Cristina Cuadros at 1 site in Spain.
Trial summary
The objective of the study is to evaluate and compare, clinically and radiographically,the effects of MTA and Biodentine when used as pulp dressings following pulpotomy in human primary molars. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Primary Molar Pulpotomy
- What is being tested?
- Pulpotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2012to Nov 2014
- Phase
- Phase 4
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- molars showing:
- symptomless exposure of vital pulp by caries
- no clinical or radiographic evidence of pulp degeneration (excessive bleeding from the root canal, internal root resorption, inter-radicular and/or furcal bone destruction)
- the possibility of proper restoration of the teeth
- no physiological resorption of more than one-third of the root
Who cannot join
- presence of systemic pathology and any history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
Official title: Clinical and Radiographic Outcomes of MTA and Biodentine in Pulpotomized Primary Molars. A Randomized Clinical Trial
The objective of the study is to evaluate and compare, clinically and radiographically,the effects of MTA and Biodentine when used as pulp dressings following pulpotomy in human primary molars.
- Conditions
- Primary Molar Pulpotomy
- Being tested
- Pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyOther
Comparison of two different pulp dressing agents
PulpotomyOther
Also called Biodentine
Comparison of two different pulp dressing agents
| Study group | Role | What they receive |
|---|---|---|
| Pulp dressing agent | Experimental | Not described Receives: Other: Pulpotomy |
| Pulp dressing | Active comparator | MTA Receives: Other: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of molars with clinical success
Measured: 12 months
Number of molars with radiographic success
Measured: 6 and 12 months
Secondary outcomes (8)
Number of molars with no evidence of radicular radiolucency
Measured: 6 and 12 months
Number of molars with no evidence of internal resorption
Measured: 6 and 12 months
Number of molars with no evidence of external resorption
Measured: 6 and 12 months
Number of molars with no evidence of furcation radiolucency
Measured: 6 and 12 months
Number of molars with no symptoms of pain
Measured: 6 and 12 months
Number of molars without swelling
Measured: 6 and 12 months
Number of molars without fistulation
Measured: 6 and 12 months
Number of molars without pathological mobility.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Primary Molar PulpotomyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cristina Cuadros
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cristina Cuadros, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591278
- Sponsor's protocol ID
- UIC-ODP-1
- Status last verified
- Nov 2014
- First submitted
- 30 Apr 2012
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Erdem AP, Guven Y, Balli B, Ilhan B, Sepet E, Ulukapi I, Aktoren O. Success rates of mineral trioxide aggregate, ferric sulfate, and formocresol pulpotomies: a 24-month study. Pediatr Dent. 2011 Mar-Apr;33(2):165-70.
PubMed 21703067Laurent P, Camps J, About I. Biodentine(TM) induces TGF-beta1 release from human pulp cells and early dental pulp mineralization. Int Endod J. 2012 May;45(5):439-48. doi: 10.1111/j.1365-2591.2011.01995.x. Epub 2011 Dec 22.
PubMed 22188368Nadin G, Goel BR, Yeung CA, Glenny AM. Pulp treatment for extensive decay in primary teeth. Cochrane Database Syst Rev. 2003;(1):CD003220. doi: 10.1002/14651858.CD003220.
PubMed 12535462Ansari G, Ranjpour M. Mineral trioxide aggregate and formocresol pulpotomy of primary teeth: a 2-year follow-up. Int Endod J. 2010 May;43(5):413-8. doi: 10.1111/j.1365-2591.2010.01695.x.
PubMed 20518934Doyle TL, Casas MJ, Kenny DJ, Judd PL. Mineral trioxide aggregate produces superior outcomes in vital primary molar pulpotomy. Pediatr Dent. 2010 Jan-Feb;32(1):41-7.
PubMed 20298652
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of MTA and Biodentine in Pulpotomized Primary Molars. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01591278
- Acronym / sponsor ID
- UIC-ODP-1
- Conditions
- Primary Molar Pulpotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cristina CuadrosUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Nov 2014 (estimated)
- First posted
- 3 May 2012 (estimated)
- 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.
The objective of the study is to evaluate and compare, clinically and radiographically,the effects of MTA and Biodentine when used as pulp dressings following pulpotomy in human primary molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulp dressing agent | Experimental | Other: Pulpotomy |
| Pulp dressing | Active comparator | Other: PulpotomyMTA |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- molars showing:
Key exclusion criteria (1 listed)
- presence of systemic pathology and any history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents
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 |
|---|---|---|
| PulpotomyComparison of two different pulp dressing agents | Other | Pulp dressing |
| PulpotomyAlso: BiodentineComparison of two different pulp dressing agents | Other | Pulp dressing agent |
Primary outcome
Number of molars with clinical success
Time frame: 12 months
Number of molars with radiographic success
Time frame: 6 and 12 months
8 secondary outcomes
Number of molars with no evidence of radicular radiolucency
Time frame: 6 and 12 months
Number of molars with no evidence of internal resorption
Time frame: 6 and 12 months
Number of molars with no evidence of external resorption
Time frame: 6 and 12 months
Number of molars with no evidence of furcation radiolucency
Time frame: 6 and 12 months
Number of molars with no symptoms of pain
Time frame: 6 and 12 months
Number of molars without swelling
Time frame: 6 and 12 months
Number of molars without fistulation
Time frame: 6 and 12 months
Number of molars without pathological mobility.
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Background: PubMed 21703067Erdem AP, Guven Y, Balli B, Ilhan B, Sepet E, Ulukapi I, Aktoren O. Success rates of mineral trioxide aggregate, ferric sulfate, and formocresol pulpotomies: a 24-month study. Pediatr Dent. 2011 Mar-Apr;33(2):165-70.
- Background: PubMed 22188368Laurent P, Camps J, About I. Biodentine(TM) induces TGF-beta1 release from human pulp cells and early dental pulp mineralization. Int Endod J. 2012 May;45(5):439-48. doi: 10.1111/j.1365-2591.2011.01995.x. Epub 2011 Dec 22.
- Background: PubMed 12535462Nadin G, Goel BR, Yeung CA, Glenny AM. Pulp treatment for extensive decay in primary teeth. Cochrane Database Syst Rev. 2003;(1):CD003220. doi: 10.1002/14651858.CD003220.
- Background: PubMed 20518934Ansari G, Ranjpour M. Mineral trioxide aggregate and formocresol pulpotomy of primary teeth: a 2-year follow-up. Int Endod J. 2010 May;43(5):413-8. doi: 10.1111/j.1365-2591.2010.01695.x.
- Background: PubMed 20298652Doyle TL, Casas MJ, Kenny DJ, Judd PL. Mineral trioxide aggregate produces superior outcomes in vital primary molar pulpotomy. Pediatr Dent. 2010 Jan-Feb;32(1):41-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pulpotomy in people with Primary Molar Pulpotomy, run by Cristina Cuadros 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 5 inclusion and 1 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 13 Nov 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Number of molars with clinical success (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT01591278, which also lists 5 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 13 Nov 2014.