PulpotomyEarly Phase 1NCT03395496
Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up
A Early Phase 1 study testing Biodentine and ProRoot (Aggregate) in people with Pulpotomy and Dental Caries, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A total of 200 primary molars with deep caries were treated with two different pulpotomy medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy, Dental Caries
- What is being tested?
- Biodentine and ProRoot (Aggregate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2013to 30 May 2016
- Phase
- Early Phase 1
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- no clinical and radiographic evidence of pulp pathology,
- no clinical and radiographic symptoms,
- no history of spontaneous pain and tenderness,
- no percussion, swelling or sinus tracts and pathologic mobility.
Who cannot join
- 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)
- furcal or periapical radiolucency teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure.
- without permanent successor
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A total of 200 primary molars with deep caries were treated with two different pulpotomy medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. The inclusion criteria for tooth selection were no clinical and radiographic evidence of pulp pathology. During 36 months of follow-up at 3-month intervals, clinical and radiographic success and failures were recorded.
- Conditions
- Pulpotomy, Dental Caries
- Being tested
- Biodentine, ProRoot (Aggregate)
- Keywords
- pulpotomy, pediatric dentistry, primary molars
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineDrug
Also called 77509635
Biodentine pulpotomy agent
ProRoot (Aggregate)Drug
Also called 75896452
ProRoot MTA pulpotomy agent
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Experimental | Dental materials Receives: Drug: Biodentine; Drug: ProRoot (Aggregate) |
| ProRoot MTA | Experimental | Dental Materials Receives: Drug: Biodentine; Drug: ProRoot (Aggregate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total success rate
Measured: 12 months after pulpotomy treatment
Secondary outcomes (1)
Total success rate
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 posted10 Jan 2018
- Study start1 May 2013
- Primary completion1 May 2016
- Study completion30 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine Koruyucu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395496
- Sponsor's protocol ID
- 2017-24692
- Other IDs
- 2017
- Status last verified
- Jan 2018
- First submitted
- 26 Dec 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up
- ClinicalTrials.gov ID
- NCT03395496
- Acronym / sponsor ID
- 2017-24692
- Conditions
- Pulpotomy, Dental Caries
- Keywords
- pulpotomy, pediatric dentistry, primary molars
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 10 Jan 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.
The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A total of 200 primary molars with deep caries were treated with two different pulpotomy medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. The inclusion criteria for tooth selection were no clinical and radiographic evidence of pulp pathology. During 36 months of follow-up at 3-month intervals, clinical and radiographic success and failures were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Experimental | Drug: Biodentine, Drug: ProRoot (Aggregate)Dental materials |
| ProRoot MTA | Experimental | Drug: Biodentine, Drug: ProRoot (Aggregate)Dental Materials |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- no clinical and radiographic evidence of pulp pathology,
- no clinical and radiographic symptoms,
- no history of spontaneous pain and tenderness,
- no percussion, swelling or sinus tracts and pathologic mobility.
Key exclusion criteria (3 listed)
- 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)
- furcal or periapical radiolucency teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure.
- without permanent successor
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: 77509635Biodentine pulpotomy agent | Drug | Biodentine, ProRoot MTA |
| ProRoot (Aggregate)Also: 75896452ProRoot MTA pulpotomy agent | Drug | Biodentine, ProRoot MTA |
Primary outcome
Total success rate
Time frame: 12 months after pulpotomy treatment
1 secondary outcome
Total success rate
Time frame: 24 months after pulpotomy treatment
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 10 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Pulpotomy
Recruiting
Short Term Comparative Assessment of MTA and Biodentine in Complete Pulpotomy for Symptomatic Irreversible Pulpitis
Symptomatic Irreversible Pulpitis (SIP)
Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Recruiting
Pomegranate Peel Extract for Primary Molar Pulpotomy
Pulpitis Reversible, Pulp Exposure, Dental
Not yet recruiting
Evaluation of Pulpotomy Techniques (Formocresol, Ferric Sulphate, Mineral Trioxide Aggregate)
Periapical Healing
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis
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 Early Phase 1 study testing Biodentine and ProRoot (Aggregate) in people with Pulpotomy and Dental Caries, run by Istanbul University at 1 site in Turkey (Türkiye).
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 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 10 Jan 2018. 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 Turkey (Türkiye). 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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: 12 months after pulpotomy treatment). 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 10 Jan 2018.