Dentin CariesNCT07260357
Comparison Of Clinical And Radiological Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeth
A study testing ProRoot MTA Pulpotomy, NeoPUTTY MTA Pulpotomy and TheraCal PT Pulpotomy in people with Dentin Caries, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized clinical trial is to compare clinical and radiological success rates of NeoPutty MTA, ProRoot MTA and TheraCal PT pulpotomy in 4-10 years old healthy pediatric patients. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Caries
- What is being tested?
- ProRoot MTA Pulpotomy, NeoPUTTY MTA Pulpotomy and TheraCal PT Pulpotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary molars with active caries and pulp exposure, assessed after intraoral periapical radiograph examination
- Presence of pulp exposure during caries excavation
- More than two-thirds of root length present
- No history of spontaneous pain
- Children aged 4-10 years with Frankl's positive or definitely positive behavior
Who cannot join
- Teeth with internal or external root resorption, periapical lesions, or widening of the periodontal ligament (PDL)
- Presence of sinus tracts or history of swelling
- Uncontrolled pulpal bleeding from the tooth, even after 5 minutes
- No pulp exposure during caries excavation
- Patients or parents unwilling to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Faculty of Dentistry
Konya, Meram, 42090
About this study
The goal of this randomized clinical trial is to compare clinical and radiological success rates of NeoPutty MTA, ProRoot MTA and TheraCal PT pulpotomy in 4-10 years old healthy pediatric patients. The main question it aims to answer is:
Which of these 3 materials are best suited for pulpotomy treatment in the aspect of clinical and radiological success rates.
Participants will undergo a pulpotomy treatment in primary molar teeth with one of these materials used.
Read the detailed description
This study was conducted on primary molar patients who applied to Necmettin Erbakan University Faculty of Dentistry Department of Pedodontics for a routine check-up, did not have any systemic problems, had a score of 3 and 4 according to the Frankl Behavior Scale, and whose parents' approval could be obtained, and had a pulp-related and active caries appearance in the lower jaw. Patients between the ages of 4 and 10 who are indicated for dental pulpotomy treatment will be included.
In our prospective randomized clinical study;
Pulpotomy treatment; Infiltrative/mandibular anesthesia is applied to the primary lower molar teeth, which are in contact with the pulp and have not experienced spontaneous pain, and wait until numbness occurs. Under rubber dam isolation, soft caries in the lower primary molar tooth is removed with a steel round bur.
Removal of pulp tissue: Starting from where the pulp is exposed, 1-2 mm is removed with a water-cooled high-speed diamond round bur.
Bleeding Control: It is washed with sterile serum and the cavity is disinfected using a cotton pellet impregnated with 2.5% Sodium Hypochlorite. It is checked that there is no residual pulp tissue left. For hemostasis, a cotton pellet impregnated with physiological saline is placed in the cavity.
Control group (Pro Root MTA) Pro Root MTA consists of powder and liquid components. The liquid part is added to the powder, mixed and placed in 30 primary molars as pulpotomy material. Glass ionomer cement is placed on it as a base material and the treatment is completed by making a permanent restoration with a stainless steel crown.
Working group (NeoPUTTY MTA) NeoPUTTY MTA is in injector form and has a paste consistency. Taken using a hand tool It is placed in 30 primary molars as pulpotomy material. As a base material on it Glass ionomer cement is placed and the treatment is completed by making a permanent restoration with a stainless steel crown.
Study group (Theracal PT) Theracal PT is in the form of a resin-containing syringe and is applied directly to 30 primary molars as pulpotomy material and polymerized with the help of a radiation device. Glass ionomer cement is placed on it as a base material and the treatment is completed by making a permanent restoration with a stainless steel crown.
When the literature is examined within the scope of our research, there are a limited number of studies comparing Pro Root MTA with NeoPUTTY MTA and Theracal PT. In this thesis study, it was aimed to compare its success on the pulp with the materials in the study group by using Pro Root MTA, which has proven its success on the pulp in the literature, in the control group. After the treatment of the teeth is completed, participants will be called for 6th and 9th month checks. During the control sessions, clinical and radiological evaluations of the relevant teeth will be made and periapical radiographs will be taken, maximum one from each tooth.
- Conditions
- Dentin Caries
- Being tested
- ProRoot MTA Pulpotomy, NeoPUTTY MTA Pulpotomy, TheraCal PT Pulpotomy
- Keywords
- Pulpotomy, Primary Teeth, Mineral Trioxide Aggregate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProRoot MTA PulpotomyOther
Teeth were pulpotomized with Pro-Root MTA in this group.
NeoPUTTY MTA PulpotomyOther
Teeth were pulpotomized with Neo-Putty MTA in this group.
TheraCal PT PulpotomyOther
Teeth were pulpotomized with Theracal PT in this group.
| Study group | Role | What they receive |
|---|---|---|
| ProRoot MTA White (Tulsa Dental Products, Tulsa, USA) | Experimental | Pro Root MTA Root Canal Repair Material Receives: Other: ProRoot MTA Pulpotomy |
| NeoPUTTY (NuSmile, Houston, USA) | Experimental | Next Generatıon Pre-Mıxed Root \& Pulp Treatment Materıal Receives: Other: NeoPUTTY MTA Pulpotomy |
| ThraCal PT (Bisco Dental Products, Schaumburg IL, Amerika) | Experimental | BISCO's TheraCal PT is a dual-cured, resin-modified calcium silicate pulpotomy treatment. Receives: Other: TheraCal PT Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeth
Clinical success will be evaluated at 6- and 9-month follow-up examinations by assessing the following parameters: spontaneous pain, tenderness to percussion, swelling, sinus/fistula formation, and pathological mobility.
Each parameter will be recorded as positive (present) or negative (absent). Tooth mobility will be graded according to Miller's Mobility Classification (Grades 0-3).
A tooth will be considered clinically successful if all parameters are negative (no symptoms) and mobility is within Miller's Grade 0-1.
Data will be aggregated and reported as the number and percentage of teeth with clinical success for each pulpotomy material group (ProRoot MTA, NeoPUTTY, and TheraCal PT).
Measured: 6 months and 9 months post-treatment
Clinical And Radiological Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeths
Radiographic success will be evaluated at 6- and 9-month follow-up visits using standardized periapical radiographs. Each radiograph will be examined for the presence or absence of the following findings: periapical radiolucency, furcal involvement, internal or external root resorption, and widening of the periodontal ligament space.
Each parameter will be recorded as positive (absent pathology) or negative (presence of any pathology).
Teeth showing no pathological findings (i.e., all parameters positive) will be classified as radiographically successful, whereas those showing any pathological change (negative) will be classified as radiographic failures.
Evaluations will be performed independently by two blinded examiners. Data will be aggregated and reported as the number and percentage of radiographically successful teeth for each pulpotomy material group (ProRoot MTA, NeoPUTTY, and TheraCal PT).
Measured: 6 months and 9 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Jan 2024
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin CariesStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe 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
- Model description
- Treatment selection of patients meeting the inclusion criteria was made using the randomized sealed envelope method. One envelope was created for each group and the patient was asked to choose which pulpotomy material would be used before the procedure. The procedure was performed by a single researcher (M.T.) who was receiving specialist training in pediatric dentistry. The teeth were restored with stainless steel crowns after the amputation treatment. Intraoral photographs were taken from the patients at the beginning, after cavity preparation and after the restoration was completed, and periapical radiographs were taken after the restorations were completed to control the restorations. The patients were called for control sessions at 6 and 9 months. A maximum of one periapical radiograph was taken from each tooth. The teeth were checked by 2 physicians (M.T. and H.A.) and recorded in the case report forms according to the determined clinical and radiographic evaluation criteria.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halenur Altan, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260357
- Sponsor's protocol ID
- NecmettinEU03
- Status last verified
- Nov 2025
- First submitted
- 15 Jul 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share the results.
Publications
Bossu M, Iaculli F, Di Giorgio G, Salucci A, Polimeni A, Di Carlo S. Different Pulp Dressing Materials for the Pulpotomy of Primary Teeth: A Systematic Review of the Literature. J Clin Med. 2020 Mar 19;9(3):838. doi: 10.3390/jcm9030838.
PubMed 32204501
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Clinical And Radiological Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeth
- ClinicalTrials.gov ID
- NCT07260357
- Acronym / sponsor ID
- NecmettinEU03
- Conditions
- Dentin Caries
- Keywords
- Pulpotomy, Primary Teeth, Mineral Trioxide Aggregate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 3 Dec 2025 (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 randomized clinical trial is to compare clinical and radiological success rates of NeoPutty MTA, ProRoot MTA and TheraCal PT pulpotomy in 4-10 years old healthy pediatric patients. The main question it aims to answer is:
Which of these 3 materials are best suited for pulpotomy treatment in the aspect of clinical and radiological success rates.
Participants will undergo a pulpotomy treatment in primary molar teeth with one of these materials used.
Detailed description
This study was conducted on primary molar patients who applied to Necmettin Erbakan University Faculty of Dentistry Department of Pedodontics for a routine check-up, did not have any systemic problems, had a score of 3 and 4 according to the Frankl Behavior Scale, and whose parents' approval could be obtained, and had a pulp-related and active caries appearance in the lower jaw. Patients between the ages of 4 and 10 who are indicated for dental pulpotomy treatment will be included.
In our prospective randomized clinical study;
Pulpotomy treatment; Infiltrative/mandibular anesthesia is applied to the primary lower molar teeth, which are in contact with the pulp and have not experienced spontaneous pain, and wait until numbness occurs. Under rubber dam isolation, soft caries in the lower primary molar tooth is removed with a steel round bur.
Removal of pulp tissue: Starting from where the pulp is exposed, 1-2 mm is removed with a water-cooled high-speed diamond round bur.
Bleeding Control: It is washed with sterile serum and the cavity is disinfected using a cotton pellet impregnated with 2.5% Sodium Hypochlorite. It is checked that there is no residual pulp tissue left. For hemostasis, a cotton pellet impregnated with physiological saline is placed in the cavity.
Control group (Pro Root MTA) Pro Root MTA consists of powder and liquid components. The liquid part is added to the powder, mixed and placed in 30 primary molars as pulpotomy material. Glass ionomer cement is placed on it as a base material and the treatment is completed by making a permanent restoration with a stainless steel crown.
Working group (NeoPUTTY MTA) NeoPUTTY MTA is in injector form and has a paste consistency. Taken using a hand tool It is placed in 30 primary molars as pulpotomy material. As a base material on it Glass ionomer cement is placed and the treatment is completed by making a permanent restoration with a stainless steel crown.
Study group (Theracal PT) Theracal PT is in the form of a resin-containing syringe and is applied directly to 30 primary molars as pulpotomy material and polymerized with the help of a radiation device. Glass ionomer cement is placed on it as a base material and the treatment is completed by making a permanent restoration with a stainless steel crown.
When the literature is examined within the scope of our research, there are a limited number of studies comparing Pro Root MTA with NeoPUTTY MTA and Theracal PT. In this thesis study, it was aimed to compare its success on the pulp with the materials in the study group by using Pro Root MTA, which has proven its success on the pulp in the literature, in the control group. After the treatment of the teeth is completed, participants will be called for 6th and 9th month checks. During the control sessions, clinical and radiological evaluations of the relevant teeth will be made and periapical radiographs will be taken, maximum one from each tooth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Treatment selection of patients meeting the inclusion criteria was made using the randomized sealed envelope method. One envelope was created for each group and the patient was asked to choose which pulpotomy material would be used before the procedure. The procedure was performed by a single researcher (M.T.) who was receiving specialist training in pediatric dentistry. The teeth were restored with stainless steel crowns after the amputation treatment. Intraoral photographs were taken from the patients at the beginning, after cavity preparation and after the restoration was completed, and periapical radiographs were taken after the restorations were completed to control the restorations. The patients were called for control sessions at 6 and 9 months. A maximum of one periapical radiograph was taken from each tooth. The teeth were checked by 2 physicians (M.T. and H.A.) and recorded in the case report forms according to the determined clinical and radiographic evaluation criteria.
| Arm | Type | Receives |
|---|---|---|
| ProRoot MTA White (Tulsa Dental Products, Tulsa, USA) | Experimental | Other: ProRoot MTA PulpotomyPro Root MTA Root Canal Repair Material |
| NeoPUTTY (NuSmile, Houston, USA) | Experimental | Other: NeoPUTTY MTA PulpotomyNext Generatıon Pre-Mıxed Root \& Pulp Treatment Materıal |
| ThraCal PT (Bisco Dental Products, Schaumburg IL, Amerika) | Experimental | Other: TheraCal PT PulpotomyBISCO's TheraCal PT is a dual-cured, resin-modified calcium silicate pulpotomy treatment. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Primary molars with active caries and pulp exposure, assessed after intraoral periapical radiograph examination
- Presence of pulp exposure during caries excavation
- More than two-thirds of root length present
- No history of spontaneous pain
- Children aged 4-10 years with Frankl's positive or definitely positive behavior
Key exclusion criteria (5 listed)
- Teeth with internal or external root resorption, periapical lesions, or widening of the periodontal ligament (PDL)
- Presence of sinus tracts or history of swelling
- Uncontrolled pulpal bleeding from the tooth, even after 5 minutes
- No pulp exposure during caries excavation
- Patients or parents unwilling to participate in 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 |
|---|---|---|
| ProRoot MTA PulpotomyTeeth were pulpotomized with Pro-Root MTA in this group. | Other | ProRoot MTA White (Tulsa Dental Products, Tulsa, USA) |
| NeoPUTTY MTA PulpotomyTeeth were pulpotomized with Neo-Putty MTA in this group. | Other | NeoPUTTY (NuSmile, Houston, USA) |
| TheraCal PT PulpotomyTeeth were pulpotomized with Theracal PT in this group. | Other | ThraCal PT (Bisco Dental Products, Schaumburg IL, Amerika) |
Primary outcome
Clinical Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeth
Time frame: 6 months and 9 months post-treatment
Clinical success will be evaluated at 6- and 9-month follow-up examinations by assessing the following parameters: spontaneous pain, tenderness to percussion, swelling, sinus/fistula formation, and pathological mobility. Each parameter will be recorded as positive (present) or negative (absent). Tooth mobility will be graded according to Miller's Mobility Classification (Grades 0-3). A tooth will be considered clinically successful if all parameters are negative (no symptoms) and mobility is within Miller's Grade 0-1. Data will be aggregated and reported as the number and percentage of teeth with clinical success for each pulpotomy material group (ProRoot MTA, NeoPUTTY, and TheraCal PT).
Clinical And Radiological Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeths
Time frame: 6 months and 9 months post-treatment
Radiographic success will be evaluated at 6- and 9-month follow-up visits using standardized periapical radiographs. Each radiograph will be examined for the presence or absence of the following findings: periapical radiolucency, furcal involvement, internal or external root resorption, and widening of the periodontal ligament space. Each parameter will be recorded as positive (absent pathology) or negative (presence of any pathology). Teeth showing no pathological findings (i.e., all parameters positive) will be classified as radiographically successful, whereas those showing any pathological change (negative) will be classified as radiographic failures. Evaluations will be performed independently by two blinded examiners. Data will be aggregated and reported as the number and percentage of radiographically successful teeth for each pulpotomy material group (ProRoot MTA, NeoPUTTY, and TheraCal PT).
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 3 Dec 2025.
- Background: PubMed 32204501Bossu M, Iaculli F, Di Giorgio G, Salucci A, Polimeni A, Di Carlo S. Different Pulp Dressing Materials for the Pulpotomy of Primary Teeth: A Systematic Review of the Literature. J Clin Med. 2020 Mar 19;9(3):838. doi: 10.3390/jcm9030838.
- Individual participant dataSharing planned: No. We will share the results.
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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.
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 study testing ProRoot MTA Pulpotomy, NeoPUTTY MTA Pulpotomy and TheraCal PT Pulpotomy in people with Dentin Caries, run by Necmettin Erbakan 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 5 inclusion and 5 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 3 Dec 2025. 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.
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 Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeth (time frame: 6 months and 9 months post-treatment). 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?
On the ClinicalTrials.gov record for NCT07260357, which also lists 1 linked publication.
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 3 Dec 2025.