Pulp Disease, DentalNCT06380296
Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars
A study testing Primary molars pulpotomies with NeoMTA and Primary molar pulpotomies with NeoPUTTY in people with Pulp Disease, Dental, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
Trial summary
The goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies (baby root canal) in children. The main question it aims to answer is: • what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications (NeoMTA and NeoPUTTY)… Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Disease, Dental
- What is being tested?
- Primary molars pulpotomies with NeoMTA and Primary molar pulpotomies with NeoPUTTY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged between 3 and 10 years
- Primary molars with no history of spontaneous or persistent pain
- Restorable primary molars with deep carious lesions approximating or reaching the pulp
- Primary molars with at least 2/3rd of the root length present
- Radiographically, the inclusion criteria were as follows: deep dentin caries approximating or reaching the pulp; no more than one-third of physiologic root resorption; no widening of the periodontal ligament (PDL) space; no pathologic internal or external root resorption; and no apical or furcal radiolucency.
- Children who can understand and speak French or English.
Who cannot join
- Primary molars with pathological mobility, tenderness to percussion, swelling, or sinus tract
- Primary molars without hemostasis after coronal pulp amputation within five minutes.
- Primary molars with widening of the periodontal ligament (PDL) space; pathologic internal or external root resorption; and apical or furcal radiolucency
About this study
Official title: Clinical and Radiographic Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies (baby root canal) in children. The main question it aims to answer is: • what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications (NeoMTA and NeoPUTTY) over a 24-month follow-up period? Healthy children aged between 3 and 10 years undergoing dental treatment under general anesthesia who have deep caries lesions approximating or reaching the nerve will be invited to participate in this study. Pulpotomies (baby root canal) will be performed by trained dentists following a protocol. Children will receive pulpotomies either with NeoMTA or NeoPUTTY, two medications indicated for the procedure. Participants will be asked to come for an appointment at 1, 6, 12 and 24 months after the procedure. Researcher will compare the clinical and radiographic performance of pulpotomies (baby root canal) done with both medications.
Read the detailed description
This single-site, double-blinded (participants and evaluators) randomized clinical trial with parallel groups will be conducted at the Division of Dentistry, Montreal Children's Hospital. Healthy children aged between 3 and 10 years undergoing dental rehabilitation under general anesthesia who have deep caries lesions approximating or reaching the pulp without any signs or symptoms of pulpal degeneration in one or more primary molars will be invited to participate in this study. All participants will be randomly assigned (1:1 ratio) into two groups: i) pulpotomy with NeoMTA; and ii) pulpotomy with NeoPutty. Follow-up visits at 1, 6, 12 and 24 months will be conducted to assess the clinical and radiographic outcomes.
The sample size calculation was done using G*Power 3.1.9.4 software (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). In a recent study conducted by our research team, the 24-month success rates of NeoMTA pulpotomy in primary molars was 98% (manuscript in preparation for submission). To account for a desired accuracy of 20%, a significance level of 5%, and a safety margin of 20% to compensate for patient dropouts, a minimum sample size of 47 teeth in each group will be required.
Trained clinical staff f will perform all primary molar pulpotomies following a standardized protocol doe each pulp medication used (NeoMTA or NeoPUTTY).
A baseline questionnaire will be filled by caregivers to assess children's sociodemographic characteristics. At each follow-up visit, standardized clinical and radiographic will be performed by trained dentists.
The post-operative clinical success will be considered as a retained tooth that is void of signs and symptoms of infection such as pain on percussion, mobility, presence of a fistula, or an abscess. Radiographic success will be determined by the lack of pathologic changes such as internal or external root resorption, or a periradicular pathosis. The extraction of the tooth due to signs and symptoms of infection will be considered as a failure.
- Conditions
- Pulp Disease, Dental
- Being tested
- Primary molars pulpotomies with NeoMTA, Primary molar pulpotomies with NeoPUTTY
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary molars pulpotomies with NeoMTAOther
Primary molar pulpotomies will be performed by trained dentists using NeoMTA, a bioactive material containing calcium silicate known for its bio-active and bone forming potential. Follow-up visits at 1, 6, 12 and 24 months will be conducted to assess success rate, and clinical and radiographic outcomes
Primary molar pulpotomies with NeoPUTTYOther
Primary molar pulpotomies will be performed by trained dentists using NeoPUTTY, a ready to use bioactive material containing calcium silicate. Follow-up visits at 1, 6, 12 and 24 months will be conducted to assess success rate, and clinical and radiographic outcomes
| Study group | Role | What they receive |
|---|---|---|
| NeoMTA | Active comparator | Trained dentists will perform the primary molar pulpotomy following a standardized protocol. After amputation of the coronal pulp, the pulp chamber will be filled with NeoMTA 2. Tooth will be then restored with an appropriately sized stainless steel crown cemented with a glass ionomer cement at the same visit. Follow-up visits will be scheduled at 1, 6, 12 and 24 months after the procedure to assess the success rate of primary molars pulpotomy. Receives: Other: Primary molars pulpotomies with NeoMTA |
| NeoPUTTY | Experimental | Trained dentists will perform the primary molar pulpotomy following a standardized protocol. After amputation of the coronal pulp, the pulp chamber will be filled with NeoPUTTY. Tooth will be then restored with an appropriately sized stainless steel crown cemented with a glass ionomer cement at the same visit. Follow-up visits will be scheduled at 1, 6, 12 and 24 months after the procedure to assess the success rate of primary molars pulpotomy. Receives: Other: Primary molar pulpotomies with NeoPUTTY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of a primary molar pulpotomy
A retained primary molar that is void of signs and symptoms of infection such as pain on percussion, mobility, presence of a fistula, or an abscess
Measured: 24 months
Radiographic success of a primary molar pulpotomy
Absence of pathologic changes such as internal or external root resorption, or a periradicular pathosis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Disease, DentalStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Ferraz dos Santos, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380296
- Sponsor's protocol ID
- 2024-10240
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06380296
- Acronym / sponsor ID
- 2024-10240
- Conditions
- Pulp Disease, Dental
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Apr 2024 (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 goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies (baby root canal) in children. The main question it aims to answer is: • what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications (NeoMTA and NeoPUTTY) over a 24-month follow-up period? Healthy children aged between 3 and 10 years undergoing dental treatment under general anesthesia who have deep caries lesions approximating or reaching the nerve will be invited to participate in this study. Pulpotomies (baby root canal) will be performed by trained dentists following a protocol. Children will receive pulpotomies either with NeoMTA or NeoPUTTY, two medications indicated for the procedure. Participants will be asked to come for an appointment at 1, 6, 12 and 24 months after the procedure. Researcher will compare the clinical and radiographic performance of pulpotomies (baby root canal) done with both medications.
Detailed description
This single-site, double-blinded (participants and evaluators) randomized clinical trial with parallel groups will be conducted at the Division of Dentistry, Montreal Children's Hospital. Healthy children aged between 3 and 10 years undergoing dental rehabilitation under general anesthesia who have deep caries lesions approximating or reaching the pulp without any signs or symptoms of pulpal degeneration in one or more primary molars will be invited to participate in this study. All participants will be randomly assigned (1:1 ratio) into two groups: i) pulpotomy with NeoMTA; and ii) pulpotomy with NeoPutty. Follow-up visits at 1, 6, 12 and 24 months will be conducted to assess the clinical and radiographic outcomes.
The sample size calculation was done using G*Power 3.1.9.4 software (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). In a recent study conducted by our research team, the 24-month success rates of NeoMTA pulpotomy in primary molars was 98% (manuscript in preparation for submission). To account for a desired accuracy of 20%, a significance level of 5%, and a safety margin of 20% to compensate for patient dropouts, a minimum sample size of 47 teeth in each group will be required.
Trained clinical staff f will perform all primary molar pulpotomies following a standardized protocol doe each pulp medication used (NeoMTA or NeoPUTTY).
A baseline questionnaire will be filled by caregivers to assess children's sociodemographic characteristics. At each follow-up visit, standardized clinical and radiographic will be performed by trained dentists.
The post-operative clinical success will be considered as a retained tooth that is void of signs and symptoms of infection such as pain on percussion, mobility, presence of a fistula, or an abscess. Radiographic success will be determined by the lack of pathologic changes such as internal or external root resorption, or a periradicular pathosis. The extraction of the tooth due to signs and symptoms of infection will be considered as a failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeoMTA | Active comparator | Other: Primary molars pulpotomies with NeoMTATrained dentists will perform the primary molar pulpotomy following a standardized protocol. After amputation of the coronal pulp, the pulp chamber will be filled with NeoMTA 2. Tooth will be then restored with an appropriately sized stainless steel crown cemented with a glass ionomer cement at the same visit. Follow-up visits will be scheduled at 1, 6, 12 and 24 months after the procedure to assess the success rate of primary molars pulpotomy. |
| NeoPUTTY | Experimental | Other: Primary molar pulpotomies with NeoPUTTYTrained dentists will perform the primary molar pulpotomy following a standardized protocol. After amputation of the coronal pulp, the pulp chamber will be filled with NeoPUTTY. Tooth will be then restored with an appropriately sized stainless steel crown cemented with a glass ionomer cement at the same visit. Follow-up visits will be scheduled at 1, 6, 12 and 24 months after the procedure to assess the success rate of primary molars pulpotomy. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy children aged between 3 and 10 years
- Primary molars with no history of spontaneous or persistent pain
- Restorable primary molars with deep carious lesions approximating or reaching the pulp
- Primary molars with at least 2/3rd of the root length present
- Radiographically, the inclusion criteria were as follows: deep dentin caries approximating or reaching the pulp; no more than one-third of physiologic root resorption; no widening of the periodontal ligament (PDL) space; no pathologic internal or external root resorption; and no apical or furcal radiolucency.
Key exclusion criteria (3 listed)
- Primary molars with pathological mobility, tenderness to percussion, swelling, or sinus tract
- Primary molars without hemostasis after coronal pulp amputation within five minutes.
- Primary molars with widening of the periodontal ligament (PDL) space; pathologic internal or external root resorption; and apical or furcal radiolucency
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 |
|---|---|---|
| Primary molars pulpotomies with NeoMTAPrimary molar pulpotomies will be performed by trained dentists using NeoMTA, a bioactive material containing calcium silicate known for its bio-active and bone forming potential. Follow-up visits at 1, 6, 12 and 24 months will be conducted to assess success rate, and clinical and radiographic outcomes | Other | NeoMTA |
| Primary molar pulpotomies with NeoPUTTYPrimary molar pulpotomies will be performed by trained dentists using NeoPUTTY, a ready to use bioactive material containing calcium silicate. Follow-up visits at 1, 6, 12 and 24 months will be conducted to assess success rate, and clinical and radiographic outcomes | Other | NeoPUTTY |
Primary outcome
Success rate of a primary molar pulpotomy
Time frame: 24 months
A retained primary molar that is void of signs and symptoms of infection such as pain on percussion, mobility, presence of a fistula, or an abscess
Radiographic success of a primary molar pulpotomy
Time frame: 24 months
Absence of pathologic changes such as internal or external root resorption, or a periradicular pathosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Primary molars pulpotomies with NeoMTA and Primary molar pulpotomies with NeoPUTTY in people with Pulp Disease, Dental, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
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 6 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: opening soon, as of the sponsor's last update on 23 Apr 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Success rate of a primary molar pulpotomy (time frame: 24 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?
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 23 Apr 2024.