Extensively Decayed Primary MolarsPhase 4NCT05149651
Efficacy of Totalfill® and ProRoot MTA® as Pulpotomy Agent in Primary Molars
A Phase 4 study testing Totalfill and MTA in people with Extensively Decayed Primary Molars, run by University Ghent at 1 site in Belgium.
Trial summary
An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design. To evaluate the outcome of using 2 pulpotomy agents: Totalfill® as study group and mineral trioxide aggregate (MTA®) as a control. Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Extensively Decayed Primary Molars
- What is being tested?
- Totalfill and MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2017to 31 Dec 2020
- Phase
- Phase 4
- 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 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient inclusion criteria
- ASA 1 patient, Patient is a completely healthy \& fit. No allergy or medical conditions.
- Patient is indicated for treatment under General Anesthesia: young age, uncooperative and extensive treatment plan.
- Parent agreed to participate in the study, and signed the written consent.
- Patient attended the out-patients pediatric dental clinic in UZ Gent.
- Tooth inclusion criteria 2.1. Clinical inclusion criteria:
Show all 20Show fewer
- Vital primary molars (first or second) with deep caries cavity with pulpal exposure.
- Only mandibular primary molar were included
- No spontaneous pain
- No history of swelling
- No sinus tract/ fistula
- Absent of tenderness in percussion
- No pathological mobility
- Restorable tooth (stainless steel crown can be placed)
- Hemostasis can be achieved with a dry cotton pellet after removal of Coronal pulp.
- 2.2. Radiographical inclusion criteria:
- At least 2/3rd of root is present
- Absence of internal or external root resorption
- Absence of pathologic root resorption
- Absence of periapical or furcation radiolucency
Who cannot join
- If one or more of the criteria mentioned above is not fulfilled, the teeth were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Outcomes of Pulpotomy of Primary Molars Using Totalfill® Bioceramic Root Repair Material -Fast Set Putty, and ProRoot White MTA®. A Randomized Controlled Trial
An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design. To evaluate the outcome of using 2 pulpotomy agents: Totalfill® as study group and mineral trioxide aggregate (MTA®) as a control.
Read the detailed description
When a tooth decay is too deep and extended into the tooth pulp, then the tooth is not indicated to be treated with a filling. Therefore, removing the diseased pulp and then cover the rest with a suitable material is required. The Purpose of this study is to check the success of pulp treatment on deciduous molars with deep caries using 2 pulp treatment agents: (Totalfill® and MTA®). The use between the materials is randomly assigned. However, the use of the materials has no side effect or complications as it is a routine dental procedure.
The participants are healthy children aged between 3 and 9 years old, and the study is taking place in Ghent University Hospital, Ghent, Belgium, and it is planned to be conducted in duration of 4 years, which include 20 months for participants recruitment.
After placing the material, the tooth is restored with stainless steel crowns, and the participant was asked for follow up to check the tooth and to take dental x-ray every 6 months.
- Conditions
- Extensively Decayed Primary Molars
- Being tested
- Totalfill, MTA
- Keywords
- Totalfill, MTA, Bioactive, calcium silicate cement, Pulpotomy, Primary molars, Bioceramics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TotalfillDrug
Also called Totalfill® Bioceramic Root Repair Material -Fast Set Putty
Totalfill® Bioceramic Root Repair Material -Fast Set Putty is a pre-mixed, bioactive calcium silicate cement which used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy.
MTADrug
Also called ProRoot White MTA®
ProRoot White MTA® is a bioactive calcium silicate cement which used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy.
| Study group | Role | What they receive |
|---|---|---|
| Totalfill | Experimental | Totalfill® Bioceramic Root Repair Material -Fast Set Putty used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy Receives: Drug: Totalfill |
| MTA | Active comparator | ProRoot White MTA® used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy Receives: Drug: MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation
Success or failure of the pulpotomy treated teeth is scored based on the Clinical scoring criteria adapted from Zurn \& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.
Measured: 6 months follow-up
Clinical evaluation
Success or failure of the pulpotomy treated teeth is scored based on the Clinical scoring criteria adapted from Zurn \& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.
Measured: 12 months follow-up
Radiographic evaluation
Success or failure of the pulpotomy treated teeth is scored based on the Radiographic scoring criteria adapted from Zurn \& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.
Measured: 6 months follow-up
Radiographic evaluation
Success or failure of the pulpotomy treated teeth is scored based on the Radiographic scoring criteria adapted from Zurn \& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.
Measured: 12 months follow-up
Secondary outcomes (1)
Time needed to place the material
To measure the time consumed to place each material and then to compare them if there is a significant difference. After removing the coronal pulp and achieving the hemostasis . The operator start the timer when he places the material till restoring the tooth with GIC.
Measured: Immediately after each intervention for a maximum of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensively Decayed Primary MolarsStudies of the same condition, open and under way.
- More trials run by University GhentThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149651
- Sponsor's protocol ID
- EC UZG 2016/0723 - 2016/0724
- Status last verified
- Nov 2023
- First submitted
- 11 May 2018
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available in the literature in the manuscript after publication
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Pulpotomy of Primary Molars Using Totalfill® Bioceramic Root Repair Material -Fast Set Putty, and ProRoot White MTA®. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05149651
- Acronym / sponsor ID
- EC UZG 2016/0723 - 2016/0724
- Conditions
- Extensively Decayed Primary Molars
- Keywords
- Totalfill, MTA, Bioactive, calcium silicate cement, Pulpotomy, Primary molars, Bioceramics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 8 Dec 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.
An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design. To evaluate the outcome of using 2 pulpotomy agents: Totalfill® as study group and mineral trioxide aggregate (MTA®) as a control.
Detailed description
When a tooth decay is too deep and extended into the tooth pulp, then the tooth is not indicated to be treated with a filling. Therefore, removing the diseased pulp and then cover the rest with a suitable material is required. The Purpose of this study is to check the success of pulp treatment on deciduous molars with deep caries using 2 pulp treatment agents: (Totalfill® and MTA®). The use between the materials is randomly assigned. However, the use of the materials has no side effect or complications as it is a routine dental procedure.
The participants are healthy children aged between 3 and 9 years old, and the study is taking place in Ghent University Hospital, Ghent, Belgium, and it is planned to be conducted in duration of 4 years, which include 20 months for participants recruitment.
After placing the material, the tooth is restored with stainless steel crowns, and the participant was asked for follow up to check the tooth and to take dental x-ray every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design.
| Arm | Type | Receives |
|---|---|---|
| Totalfill | Experimental | Drug: TotalfillTotalfill® Bioceramic Root Repair Material -Fast Set Putty used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy |
| MTA | Active comparator | Drug: MTAProRoot White MTA® used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (20 listed)
- Patient inclusion criteria
- Tooth inclusion criteria 2.1. Clinical inclusion criteria:
- At least 2/3rd of root is present
- Absence of internal or external root resorption
- Absence of pathologic root resorption
Key exclusion criteria (1 listed)
- If one or more of the criteria mentioned above is not fulfilled, the teeth were excluded from 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 |
|---|---|---|
| TotalfillAlso: Totalfill® Bioceramic Root Repair Material -Fast Set PuttyTotalfill® Bioceramic Root Repair Material -Fast Set Putty is a pre-mixed, bioactive calcium silicate cement which used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy. | Drug | Totalfill |
| MTAAlso: ProRoot White MTA®ProRoot White MTA® is a bioactive calcium silicate cement which used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy. | Drug | MTA |
Primary outcome
Clinical evaluation
Time frame: 6 months follow-up
Success or failure of the pulpotomy treated teeth is scored based on the Clinical scoring criteria adapted from Zurn \& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.
Clinical evaluation
Time frame: 12 months follow-up
Success or failure of the pulpotomy treated teeth is scored based on the Clinical scoring criteria adapted from Zurn \& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.
Radiographic evaluation
Time frame: 6 months follow-up
Success or failure of the pulpotomy treated teeth is scored based on the Radiographic scoring criteria adapted from Zurn \& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.
Radiographic evaluation
Time frame: 12 months follow-up
Success or failure of the pulpotomy treated teeth is scored based on the Radiographic scoring criteria adapted from Zurn \& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.
1 secondary outcome
Time needed to place the material
Time frame: Immediately after each intervention for a maximum of the intervention
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 2023.
- Individual participant dataSharing planned: Yes. The data will be available in the literature in the manuscript after publication
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 Phase 4 study testing Totalfill and MTA in people with Extensively Decayed 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 20 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 22 Nov 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 evaluation (time frame: 6 months follow-up). The study lists 4 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 2023.