Primary Molar PulpotomyNCT04902495
Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements
A study testing MTA Pro Root, MTA HP Repair and Biodentine in people with Primary Molar Pulpotomy, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The objective of the study is to evaluate the success rate of pulpotomies in temporary molars using different types of hemostats and pulp coating materials based on tricalcium silicates, in patients who have attended the Dental Clinic of the International University of Catalonia (UIC). Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Molar Pulpotomy
- What is being tested?
- MTA Pro Root, MTA HP Repair and Biodentine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jan 2017to 12 Dec 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Responsible patients or parents or guardians who demonstrate that they understand the study and are willing to participate, as evidenced by signing the voluntary informed consent and receiving a signed and dated copy of the informed consent form.
- Children under 18 years of age with informed parental consent, correctly understood.
- Patient understands and is willing to comply with all study procedures and restrictions.
- Absence of clinical and radiographic evidence of pulp degeneration such as excessive bleeding, internal and / or external root resorption, destruction of the furcation.
- Asymptomatic and vital primary molars whose pulp exposure occurred during caries removal.
Who cannot join
- Patients with systemic pathologies (diabetes, inmunosuppresed or any clinically significant or relevant oral abnormality).
- Previous history of allergic reaction to local anesthesics or to the different constituents of the pulp agents to be studied.
- Pulp diagnosis of irreversible pulpits or pulp necrosis, root resorption, root fractures, pathological mobility, spontaneous pain, impossibility of restoration, and if pulpotomy is not the treatment of choice.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Francisco Guinot Jimeno, DDS, MsC, 0034 93 5045000, fguinot79@hotmail.com
Francisco Guinot Jimeno, DDS, MsC
About this study
Official title: Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements.
The objective of the study is to evaluate the success rate of pulpotomies in temporary molars using different types of hemostats and pulp coating materials based on tricalcium silicates, in patients who have attended the Dental Clinic of the International University of Catalonia (UIC).
Read the detailed description
This prospective randomized clinical trial study has been approved by the
Scientific Committee in January of 2017 and by Ethics Committee (END-ECL- 2017-01) . It will be conducted in patients needing a vital pulp
therapy treatment at the Pediatric Dentistry Department of Universitat Internacional de Catalunya (Sant Cugat del Vallés, Barcelona, Spain). The necessary statistical sample size assuming an alpha risk of 0.05, a beta risk of 0.05 and a power of 95% sample, the required sample obtained by group resulted in 52. Given an estimate upwards of 20% of drop-outs in controls, the final size results in 62.4 (63 cases per group).
The data collection will be recollected using Excel program. Statgraphics Centurion XV software (StatPoint Technologies, Inc., Warrenton, VA, USA) will be used for statistical analysis. The chi-square test will be used and logistic regression analysis of the results will be performed to assess differences between groups with a significance level of P <0.05.
- Conditions
- Primary Molar Pulpotomy
- Being tested
- MTA Pro Root, MTA HP Repair, Biodentine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA Pro RootOther
pulp therapy
MTA HP RepairOther
pulp therapy
BiodentineOther
pulp therapy
| Study group | Role | What they receive |
|---|---|---|
| Pulp Dressing MTA Angelus | Experimental | pulp therapy Receives: Other: MTA HP Repair |
| Pulp Dressing MTA Pro Root | Experimental | pulp therapy Receives: Other: MTA Pro Root |
| Pulp Dressing Biodentine | Experimental | pulp therapy Receives: Other: Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual examination
Clinical examination.Data will be recorded in terms of clinical signs of success.Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination.
Measured: 12 months
Radiographic Success
RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis or pathology root resorption.
Measured: 12 months
Secondary outcomes (8)
Radicular Radiolucency
RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis.
Measured: 12 months
Internal Resorption
RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption.
Measured: 12 months
External Resorption
RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption.
Measured: 12 months
Furcation Radiolucency
RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis.
Measured: 12 months
Symptoms of pain
Clinical examination,The patient will be recalled for control . Data will be recorded in terms of presence of symptoms, clinical and radiographic signs of success / failure, vertical and lateral percussion, periodontal probing and periapical and bitewing be implemented following the same methodology as in the initial evaluation.Clinical failure was determined by the subjective symptoms as explained by the participants.
Measured: 12 months
Swelling
Clinical examination . Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including swelling.
Measured: 12 months
Fistulation
Clinical and RX examination,The patient will be recalled for control .Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including abscess.
Measured: 12 months
Pathological Mobility
Clinical examination,The patient will be recalled for control.Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including mobility.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start12 Jan 2017
- Primary completion1 Nov 2024 (estimated)
- Study completion12 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Guinot-Jimeno, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902495
- Sponsor's protocol ID
- UIC
- Status last verified
- Apr 2024
- First submitted
- 30 Jun 2020
- Last updated
- 5 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 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements.
- ClinicalTrials.gov ID
- NCT04902495
- Acronym / sponsor ID
- UIC
- Conditions
- Primary Molar Pulpotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 12 Dec 2024 (estimated)
- First posted
- 26 May 2021 (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 objective of the study is to evaluate the success rate of pulpotomies in temporary molars using different types of hemostats and pulp coating materials based on tricalcium silicates, in patients who have attended the Dental Clinic of the International University of Catalonia (UIC).
Detailed description
This prospective randomized clinical trial study has been approved by the
Scientific Committee in January of 2017 and by Ethics Committee (END-ECL- 2017-01) . It will be conducted in patients needing a vital pulp
therapy treatment at the Pediatric Dentistry Department of Universitat Internacional de Catalunya (Sant Cugat del Vallés, Barcelona, Spain). The necessary statistical sample size assuming an alpha risk of 0.05, a beta risk of 0.05 and a power of 95% sample, the required sample obtained by group resulted in 52. Given an estimate upwards of 20% of drop-outs in controls, the final size results in 62.4 (63 cases per group).
The data collection will be recollected using Excel program. Statgraphics Centurion XV software (StatPoint Technologies, Inc., Warrenton, VA, USA) will be used for statistical analysis. The chi-square test will be used and logistic regression analysis of the results will be performed to assess differences between groups with a significance level of P <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulp Dressing MTA Angelus | Experimental | Other: MTA HP Repairpulp therapy |
| Pulp Dressing MTA Pro Root | Experimental | Other: MTA Pro Rootpulp therapy |
| Pulp Dressing Biodentine | Experimental | Other: Biodentinepulp therapy |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Responsible patients or parents or guardians who demonstrate that they understand the study and are willing to participate, as evidenced by signing the voluntary informed consent and receiving a signed and dated copy of the informed consent form.
- Children under 18 years of age with informed parental consent, correctly understood.
- Patient understands and is willing to comply with all study procedures and restrictions.
- Absence of clinical and radiographic evidence of pulp degeneration such as excessive bleeding, internal and / or external root resorption, destruction of the furcation.
- Asymptomatic and vital primary molars whose pulp exposure occurred during caries removal.
Key exclusion criteria (3 listed)
- Patients with systemic pathologies (diabetes, inmunosuppresed or any clinically significant or relevant oral abnormality).
- Previous history of allergic reaction to local anesthesics or to the different constituents of the pulp agents to be studied.
- Pulp diagnosis of irreversible pulpits or pulp necrosis, root resorption, root fractures, pathological mobility, spontaneous pain, impossibility of restoration, and if pulpotomy is not the treatment of choice.
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 |
|---|---|---|
| MTA Pro Rootpulp therapy | Other | Pulp Dressing MTA Pro Root |
| MTA HP Repairpulp therapy | Other | Pulp Dressing MTA Angelus |
| Biodentinepulp therapy | Other | Pulp Dressing Biodentine |
Primary outcome
visual examination
Time frame: 12 months
Clinical examination.Data will be recorded in terms of clinical signs of success.Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination.
Radiographic Success
Time frame: 12 months
RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis or pathology root resorption.
8 secondary outcomes
Radicular Radiolucency
Time frame: 12 months
Internal Resorption
Time frame: 12 months
External Resorption
Time frame: 12 months
Furcation Radiolucency
Time frame: 12 months
Symptoms of pain
Time frame: 12 months
Swelling
Time frame: 12 months
Fistulation
Time frame: 12 months
Pathological Mobility
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTA Pro Root, MTA HP Repair and Biodentine in people with Primary Molar Pulpotomy, run by Universitat Internacional de Catalunya 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 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. 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.
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?
Contact Francisco Guinot Jimeno, DDS, MsC (0034 93 504 50 00, fguinot79@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual examination (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?
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 5 Apr 2024.