Extensive Decay in Primary MolarsPhase 3NCT03135626
Comparison of The Success Rates of Four Different Pulpotomy Techniques
A Phase 3 study testing Biodentine, ProRoot (Aggregate) and MTA Plus in people with Extensive Decay in Primary Molars, run by Istanbul University.
Trial summary
This randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA and MTA Plus®). Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Extensive Decay in Primary Molars
- What is being tested?
- Biodentine, ProRoot (Aggregate) and MTA Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2013to 15 Feb 2016
- Phase
- Phase 3
- 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 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients were eligible if they were 5 to 7 years old, healthy and cooperative, and had at least four carious primary molars, each of which was in a different quadrant and required a pulpotomy. The criteria for the selection of the teeth to be included in the study were presence of deep caries, presence of at least two-thirds of the root length radiographically and being restorable.
Who cannot join
- The exclusion criteria were the presence of any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL) space, furcal or periapical radiolucency and teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure. Teeth without permanent successor were not also included in the study.
About this study
This randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116 primary molars in 29 children were treated by pulpotomy and followed for a period of 24 months.
- Conditions
- Extensive Decay in Primary Molars
- Being tested
- Biodentine, ProRoot (Aggregate), MTA Plus, Ferric Sulfate 20 % Dental Gel
- Keywords
- Pulpotomy, Primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineDrug
Also called 77509635
ProRoot (Aggregate)Drug
Also called 75896452
MTA PlusDrug
Also called 85303191
Ferric Sulfate 20 % Dental GelDrug
Also called Viscostat
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Experimental | Biodentine pulpotomy agent Receives: Drug: Biodentine |
| ProRoot MTA | Experimental | ProRoot MTA pulpotomy agent Receives: Drug: ProRoot (Aggregate) |
| MTA Plus | Experimental | MTA Plus pulpotomy agent Receives: Drug: MTA Plus |
| Ferric Sulfate 20% Dental Gel | Active comparator | Ferric Sulfate %20 Dental Gel pulpotomy agent Receives: Drug: Ferric Sulfate 20 % Dental Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total success rate
Number of molars with both clinically and radiographically successful
Measured: 6 months after pulpotomy treatment
Total success rate
Number of molars with both clinically and radiographically successful
Measured: 12 months after pulpotomy treatment
Total success rate
Number of molars with both clinically and radiographically successful
Measured: 24 months after pulpotomy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start15 Mar 2013
- Primary completion15 Jan 2014
- Study completion15 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Decay in Primary MolarsStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth study design was used
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Guven, Istanbul University
- Investigators
- Yeliz Guven, Dr., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135626
- Sponsor's protocol ID
- 2012/1728-1288
- Status last verified
- Apr 2017
- First submitted
- 26 Apr 2017
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Success Rates of Four Different Pulpotomy Techniques
- ClinicalTrials.gov ID
- NCT03135626
- Acronym / sponsor ID
- 2012/1728-1288
- Conditions
- Extensive Decay in Primary Molars
- Keywords
- Pulpotomy, Primary molars
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Mar 2013 (actual)
- Primary completion
- 15 Jan 2014 (actual)
- Study completion
- 15 Feb 2016 (actual)
- First posted
- 1 May 2017 (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 randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116 primary molars in 29 children were treated by pulpotomy and followed for a period of 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Split-mouth study design was used
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Experimental | Drug: BiodentineBiodentine pulpotomy agent |
| ProRoot MTA | Experimental | Drug: ProRoot (Aggregate)ProRoot MTA pulpotomy agent |
| MTA Plus | Experimental | Drug: MTA PlusMTA Plus pulpotomy agent |
| Ferric Sulfate 20% Dental Gel | Active comparator | Drug: Ferric Sulfate 20 % Dental GelFerric Sulfate %20 Dental Gel pulpotomy agent |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients were eligible if they were 5 to 7 years old, healthy and cooperative, and had at least four carious primary molars, each of which was in a different quadrant and required a pulpotomy. The criteria for the selection of the teeth to be included in the study were presence of deep caries, presence of at least two-thirds of the root length radiographically and being restorable.
Key exclusion criteria (1 listed)
- The exclusion criteria were the presence of any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL) space, furcal or periapical radiolucency and teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure. Teeth without permanent successor were not also included in the study.
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 |
|---|---|---|
| BiodentineAlso: 77509635 | Drug | Biodentine |
| ProRoot (Aggregate)Also: 75896452 | Drug | ProRoot MTA |
| MTA PlusAlso: 85303191 | Drug | MTA Plus |
| Ferric Sulfate 20 % Dental GelAlso: Viscostat | Drug | Ferric Sulfate 20% Dental Gel |
Primary outcome
Total success rate
Time frame: 6 months after pulpotomy treatment
Number of molars with both clinically and radiographically successful
Total success rate
Time frame: 12 months after pulpotomy treatment
Number of molars with both clinically and radiographically successful
Total success rate
Time frame: 24 months after pulpotomy treatment
Number of molars with both clinically and radiographically successful
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 1 May 2017.
- Individual participant dataSharing planned: Undecided
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.
Yeliz Guven, Dr. principal investigator
Istanbul University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biodentine, ProRoot (Aggregate) and MTA Plus in people with Extensive Decay in Primary Molars, run by Istanbul University.
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 1 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: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
Total success rate (time frame: 6 months after pulpotomy treatment). The study lists 3 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 1 May 2017.