Extensive Decay in Primary MolarsPhase 3NCT01733420
Biodentine Versus White MTA Pulpotomy
A Phase 3 study testing Biodentine pulpotomy, White MTA pulpotomy and Tempophore pulpotomy in people with Extensive Decay in Primary Molars, run by University Ghent at 1 site in Belgium.
Trial summary
A clinical trial to evaluate and compare three different products used for endodontic treatment (taking the infected nerve out of the teeth) of primary teeth. Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the former iodoform product. Read more about this study
- Who is it for?
- Ages 2 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Extensive Decay in Primary Molars
- What is being tested?
- Biodentine pulpotomy, White MTA pulpotomy and Tempophore pulpotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Oct 2011to 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 2 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients (Children with carious deciduous molars indicated for pulpotomy) belonging to the category of ASA I according to the 'American Society of Anaesthesiologists'.
- Patients without any known medical history of systemic complications contradicting pulp treatment.
- Patients are indicated for treatment under general anaesthesia due to polycaries / fear / anxiety / very young age.
- Written consent is obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical and Radiographic Efficacy of Biodentine™ and White Mineral Trioxide Aggregate in Deciduous Molar Pulpotomy - a Randomized Control Trial
A clinical trial to evaluate and compare three different products used for endodontic treatment (taking the infected nerve out of the teeth) of primary teeth.
Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the former iodoform product.
- Conditions
- Extensive Decay in Primary Molars
- Being tested
- Biodentine pulpotomy, White MTA pulpotomy, Tempophore pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodentine pulpotomyDrug
White MTA pulpotomyDrug
Tempophore pulpotomyDrug
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Experimental | Pulpotomy using Biodentine as pulpotomy medicine. Receives: Drug: Biodentine pulpotomy |
| White Mineral trioxide Aggregate (MTA) | Active comparator | Pulpotomy using white MTA as pulpotomy medicine. Receives: Drug: White MTA pulpotomy |
| Tempophore | Active comparator | Pulpotomy using Tempophore as pulpotomy medicine in a control group. Receives: Drug: Tempophore pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical successes after pulpotomy.
clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
Measured: at baseline visit
Clinical success after pulpotomy.
clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
Measured: 3 months after pulpotomy.
Clinical successes after pulpotomy.
Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
Measured: 6 months after pulpotomy.
Clinical successes after pulpotomy.
Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
Measured: 12 months after pulpotomy.
Radiographic successes after pulpotomy.
Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.
Measured: at baseline visit
Radiographic successes after pulpotomy.
Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.
Measured: 6 months after pulpotomy.
Radiographic successes after pulpotomy.
Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.
Measured: 12 months after pulpotomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study start4 Oct 2011
- Primary completionNov 2015
- Study completionFeb 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.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Martens, PhD, DDS, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733420
- Sponsor's protocol ID
- 2011/538
- Status last verified
- Nov 2021
- First submitted
- 7 Nov 2012
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Radiographic Efficacy of Biodentine™ and White Mineral Trioxide Aggregate in Deciduous Molar Pulpotomy - a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01733420
- Acronym / sponsor ID
- 2011/538
- Conditions
- Extensive Decay in Primary Molars
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 4 Oct 2011 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Nov 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.
A clinical trial to evaluate and compare three different products used for endodontic treatment (taking the infected nerve out of the teeth) of primary teeth.
Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the former iodoform product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Experimental | Drug: Biodentine pulpotomyPulpotomy using Biodentine as pulpotomy medicine. |
| White Mineral trioxide Aggregate (MTA) | Active comparator | Drug: White MTA pulpotomyPulpotomy using white MTA as pulpotomy medicine. |
| Tempophore | Active comparator | Drug: Tempophore pulpotomyPulpotomy using Tempophore as pulpotomy medicine in a control group. |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients (Children with carious deciduous molars indicated for pulpotomy) belonging to the category of ASA I according to the 'American Society of Anaesthesiologists'.
- Patients without any known medical history of systemic complications contradicting pulp treatment.
- Patients are indicated for treatment under general anaesthesia due to polycaries / fear / anxiety / very young age.
- Written consent is obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Biodentine pulpotomy | Drug | Biodentine |
| White MTA pulpotomy | Drug | White Mineral trioxide Aggregate (MTA) |
| Tempophore pulpotomy | Drug | Tempophore |
Primary outcome
Clinical successes after pulpotomy.
Time frame: at baseline visit
clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
Clinical success after pulpotomy.
Time frame: 3 months after pulpotomy.
clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
Clinical successes after pulpotomy.
Time frame: 6 months after pulpotomy.
Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
Clinical successes after pulpotomy.
Time frame: 12 months after pulpotomy.
Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
Radiographic successes after pulpotomy.
Time frame: at baseline visit
Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.
Radiographic successes after pulpotomy.
Time frame: 6 months after pulpotomy.
Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.
Radiographic successes after pulpotomy.
Time frame: 12 months after pulpotomy.
Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.
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 22 Nov 2021.
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.
Luc Martens, PhD, DDS principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biodentine pulpotomy, White MTA pulpotomy and Tempophore pulpotomy in people with Extensive Decay in Primary Molars, run by University Ghent at 1 site in Belgium.
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 0 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 22 Nov 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 Belgium. 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 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?
Clinical successes after pulpotomy. (time frame: at baseline visit). The study lists 7 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 22 Nov 2021.