PulpotomyNCT06874062
Evaluation of Primary Tooth Pulpotomy With Resin Modified Calcium Silicate
A study testing Neoputty MTA Pulpotomy Treatment, ProRoot MTA Pulpotomy Treatment and Theracal PT Pulpotomy Treatment in people with Pulpotomy, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate whether Theracal PT, a resin-modified calcium silicate-based material, can be successfully used in pulpotomy treatment for primary molar teeth. The efficacy of this material will be compared with MTA in its putty form (Neoputty) and powder-liquid form (ProRoot). Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy
- What is being tested?
- Neoputty MTA Pulpotomy Treatment, ProRoot MTA Pulpotomy Treatment and Theracal PT Pulpotomy Treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2023to 18 Nov 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
- Deep dentin caries,
- Lamina dura and periodontal interval can be observed normally,
- 2/3 of the root length is present,
- The permanent tooth germ below is present and its position is normal,
- If there is a history of provoked pain (the type of pain that goes away when the stimulus is removed),
- If there is a history of pain (short-term provoked pain, the pain goes away when the stimulus is removed,
Show all 9Show fewer
- Teeth with mechanical perforation larger than a needle tip in the perforation area or perforated with caries,
- Teeth with light-colored bleeding and easily controlled within 3-5 minutes,
- Teeth that can be restored with PÇK were included in the study
Who cannot join
- Lesions in the inter-root and periapical region,
- Pathological external or internal root resorption,
- Canal calcification,
- Deformities such as taurodontism,
- Spontaneous pain or night pain,
- Structural anomalies,
Show all 11Show fewer
- Abscess, swelling or fistula,
- Pathological mobility,
- Sensitivity to palpation and percussion,
- Infraocclusion,
- Dark, intense bleeding in the canal orifices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of the Success of Resin-Modified Calcium Silicate in Primary Tooth Pulpotomy
The goal of this clinical trial is to evaluate whether Theracal PT, a resin-modified calcium silicate-based material, can be successfully used in pulpotomy treatment for primary molar teeth. The efficacy of this material will be compared with MTA in its putty form (Neoputty) and powder-liquid form (ProRoot). The main questions this study aims to answer are: Is Theracal PT as effective as MTA, the gold standard for pulpotomy treatment? Is Neoputty MTA, which is easier to handle, more effective than ProRoot MTA? The study will include systemically healthy children aged 4 to 9 years with at least one primary molar requiring pulpotomy. Treated teeth will be evaluated clinically and radiographically at 3, 6, and 12 months.
Read the detailed description
Tooth decay is a complex process of enamel demineralization and remineralization caused by organic acids produced by microorganisms in the dental plaque. When this balance shifts in favor of demineralization, caries formation occurs. Initially, decay begins with small surface roughness or subsurface demineralization, followed by cavitation and subsequent pulp involvement.
Tooth decay, one of the most common chronic diseases in childhood, negatively impacts the quality of life when left untreated, leading to problems such as pain, abscess formation, tooth loss, nutritional deficiencies, and speech disorders. To prevent early loss of primary teeth and maintain the health of the oral and surrounding tissues, restorative or endodontic treatments are applied. Treatment methods for deep dentin caries in primary teeth include indirect pulp capping, direct pulp capping, and amputation, with amputation being the most commonly used vital pulp therapy. Amputation is indicated when the pulp is either healthy or reversibly damaged and shows no signs of pulp degeneration, and the pulp becomes exposed during caries removal due to decay or mechanical causes. The goal of treatment is to preserve the vitality of the radicular pulp, control pain and inflammation, and maintain the tooth until its physiological exfoliation time. The selection of appropriate materials and techniques for amputation therapy is of critical importance. Although several studies have investigated the success of amputation materials and techniques, the ideal amputation material has not yet been defined. The ideal material and technique should be bactericidal, harmless to the pulp and surrounding tissues, support the healing of the root pulp, and contribute to the preservation of remaining tissues without affecting physiological root resorption. Additionally, factors such as cost and ease of application should also be considered in material selection. Therefore, efforts to identify the ideal amputation material continue.
The aim of this study is to evaluate the clinical and radiographic success of Theracal PT®, ProRoot® MTA, and Neoputty® MTA, and to examine the relationship between these outcomes and factors such as age, gender, the position of the tooth in the arch, and the presence of provoked pain prior to treatment.
The following hypotheses were proposed in our study:
Hypothesis 1: There is no difference in the 12-month clinical and radiographic success rates of primary tooth amputation treatments performed using Neoputty® MTA, ProRoot® MTA, and Theracal PT®.
Hypothesis 2: The 12-month clinical and radiographic success of amputation treatments performed using Neoputty® MTA, ProRoot® MTA, and Theracal PT® is not influenced by age, gender, the position of the tooth in the arch, or the presence of provoked pain prior to treatment.
This study was conducted in accordance with the Ataturk University Faculty of Medicine Ethics Committee approval (Date: 30.03.2023/ Session no:02/ Decision no:04) and guidelines of the Helsinki Declaration. The study was supported by the Scientific Research Projects Coordination Unit of Atatürk University under project number TDH-2023-13045. In this study, the teeth to be treated were randomly assigned using stratified randomization, ensuring an equal number of teeth in each study group. The research design was based on a parallel groups model. When multiple teeth from the same patient participated in the study, randomization was also applied for the other materials to be used. Patient selection, examination, treatment, and follow-up processes were carried out by a single researcher undergoing specialty training in the Department of Pediatric Dentistry.
- Conditions
- Pulpotomy
- Being tested
- Neoputty MTA Pulpotomy Treatment, ProRoot MTA Pulpotomy Treatment, Theracal PT Pulpotomy Treatment, Stainless Steel Crown Application
- Keywords
- pulpotomy, mineral trioxide aggregate, resin-modified calcium silicate cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoputty MTA Pulpotomy TreatmentProcedure or surgery
All caries were removed before entering the pulp chamber. Once all caries were removed, a carbide bur was used under copious water spray to expose the pulp chamber.Coronal pulp is removed with a round bur on a slow speed handpiece.
Hemostasis was achieved by applying a cotton pellet moistened with sterile saline for no more than 5 minutes. After achieving hemostasis, Neoputty MTA was placed.
ProRoot MTA Pulpotomy TreatmentProcedure or surgery
All caries were removed before entering the pulp chamber. Once all caries were removed, a carbide bur was used under copious water spray to expose the pulp chamber.Coronal pulp is removed with a round bur on a slow speed handpiece.
Hemostasis was achieved by applying a cotton pellet moistened with sterile saline for no more than 5 minutes. After achieving hemostasis, ProRoot MTA was placed.
Theracal PT Pulpotomy TreatmentProcedure or surgery
All caries were removed before entering the pulp chamber. Once all caries were removed, a carbide bur was used under copious water spray to expose the pulp chamber.Coronal pulp is removed with a round bur on a slow speed handpiece.
Hemostasis was achieved by applying a cotton pellet moistened with sterile saline for no more than 5 minutes. After achieving hemostasis, Theracal PT was placed.
Stainless Steel Crown ApplicationProcedure or surgery
After pulpotomy treatment, the pulpotomy material was covered using a capsule-form glass ionomer (EQUIA Forte®, GC, Tokyo, Japan). In the same session, preparation was performed for the placement of a stainless steel crown (SSC), and an appropriately sized SSC (3M ESPE, Seefeld, Germany) was selected based on visual estimation. After trial fitting on the tooth, the crown was cemented using a capsule-form glass ionomer (Riva, SDI Ltd., Victoria, Australia).
| Study group | Role | What they receive |
|---|---|---|
| NeoPutty MTA | Experimental | A ready-to-use putty-form Neoputty® MTA with a minimum piston length of 1.5 mm was placed on the pulp chamber floor using a sterile dental spatula. The material was adapted to the canal orifices with the aid of a cotton pellet that had been lightly moistened with sterile saline. Receives: Procedure: Neoputty MTA Pulpotomy Treatment; Procedure: Stainless Steel Crown Application |
| ProRoot MTA | Experimental | Using a sterile glass and spatula, an adequate amount of powder and liquid was mixed for approximately 1 minute until a homogeneous consistency was achieved, following the manufacturer's recommendations. The ProRoot® MTA, prepared to a putty-like consistency, was transferred to the pulp chamber using a sterile dental spatula and adapted to the canal orifices with the aid of a cotton pellet. Receives: Procedure: ProRoot MTA Pulpotomy Treatment; Procedure: Stainless Steel Crown Application |
| Theracal PT | Experimental | The TheraCal PT® package contains a 4 g tube and 10 single-use mixing tips. One of the disposable mixing tips was attached to the tube, and the material was mixed within the tip by pressing the plunger. The material was then directly applied to the pulp chamber. Adaptation of the material to the canal orifices was verified using a sterile cement applicator. Polymerization was performed for 10 seconds using a Woodpecker LED B (Guilin Woodpecker Medical Instrument Co., Ltd., China) curing light device, following the manufacturer's instructions. Receives: Procedure: Theracal PT Pulpotomy Treatment; Procedure: Stainless Steel Crown Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
No spontaneous, provoked (developing due to a stimulus) or night pain complaints.
No sensitivity to percussion or palpation. No pathological mobility in the tooth. No abscess or fistula in the tooth. If any of these findings are detected, the treatment is considered clinically unsuccessful.
Measured: 1 Month - 1 Year
Radiographic Success
No internal or external root resorption. No periapical or inter-root lesion. No widening of the periodontal space. If any of these findings are detected, the treatment is considered radiographically unsuccessful.
Measured: 3 Month - 1 Year
Secondary outcomes (4)
The Impact of Patient's Age on 12-Month Radiographic Success of Treatment.
The patient's age was compared with the radiographic success parameters at 12 months. Radiographic success parameters:
No internal or external root resorption. No periapical or inter-root lesion. No widening of the periodontal space.
Measured: From treatment to the end of 12 months
The Impact of Patient's Gender on 12-Month Radiographic Success of Treatment.
The patient's gender was compared with the radiographic success parameters at 12 months. Radiographic success parameters:
No internal or external root resorption. No periapical or inter-root lesion. No widening of the periodontal space.
Measured: From treatment to the end of 12 months
The Impact of Tooth Position in the Dental Arch on the 12-Month Radiographic Success of Treatment
The tooth position in the dental arch was compared with the radiographic success parameters at 12 months. Radiographic success parameters:
No internal or external root resorption. No periapical or inter-root lesion. No widening of the periodontal space.
Measured: From treatment to the end of 12 months
The Impact of Pre-Treatment Provoked Pain on the 12-Month Radiographic Success of Treatment.
The presence of provoked pain before treatment in the patient was compared with radiographic success parameters at the 12th month. Radiographic success parameters:
No internal or external root resorption. No periapical or inter-root lesion. No widening of the periodontal space.
Measured: From treatment to the end of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start20 Jun 2023
- Primary completion1 Oct 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PulpotomyStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Yücel, Ataturk University
- Investigators
- Fatih Şengül, Phd, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874062
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/257
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cordell S, Kratunova E, Marion I, Alrayyes S, Alapati SB. A Randomized Controlled Trial Comparing the Success of Mineral Trioxide Aggregate and Ferric Sulfate as Pulpotomy Medicaments for Primary Molars. J Dent Child (Chic). 2021 May 15;88(2):120-128.
PubMed 34321144Waterhouse P. Are different pulp treatment techniques and associated medicaments effective for the treatment of extensive decay in primary teeth? Evid Based Dent. 2021 Jan;22(1):12-13. doi: 10.1038/s41432-021-0162-6.
PubMed 33772121Celik B, Atac AS, Cehreli ZC, Uysal S. A randomized trial of mineral trioxide aggregate cements in primary tooth pulpotomies. J Dent Child (Chic). 2013 Sep-Dec;80(3):126-32.
PubMed 24351693Wassel M, Hamdy D, Elghazawy R. Evaluation of four vital pulp therapies for primary molars using a dual-cured tricalcium silicate (TheraCal PT): one-year results of a non-randomized clinical trial. J Clin Pediatr Dent. 2023 Mar;47(2):10-22. doi: 10.22514/jocpd.2023.004. Epub 2023 Mar 3.
PubMed 36890738Yucel R, Sengul F. Clinical and radiographic outcomes of three calcium silicate-based cements in primary tooth pulpotomy: a randomized clinical trial. BMC Oral Health. 2026 Mar 19;26(1):928. doi: 10.1186/s12903-026-08129-5.
PubMed 41857596
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of the Success of Resin-Modified Calcium Silicate in Primary Tooth Pulpotomy
- ClinicalTrials.gov ID
- NCT06874062
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/257
- Conditions
- Pulpotomy
- Keywords
- pulpotomy, mineral trioxide aggregate, resin-modified calcium silicate cement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 13 Mar 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 clinical trial is to evaluate whether Theracal PT, a resin-modified calcium silicate-based material, can be successfully used in pulpotomy treatment for primary molar teeth. The efficacy of this material will be compared with MTA in its putty form (Neoputty) and powder-liquid form (ProRoot). The main questions this study aims to answer are: Is Theracal PT as effective as MTA, the gold standard for pulpotomy treatment? Is Neoputty MTA, which is easier to handle, more effective than ProRoot MTA? The study will include systemically healthy children aged 4 to 9 years with at least one primary molar requiring pulpotomy. Treated teeth will be evaluated clinically and radiographically at 3, 6, and 12 months.
Detailed description
Tooth decay is a complex process of enamel demineralization and remineralization caused by organic acids produced by microorganisms in the dental plaque. When this balance shifts in favor of demineralization, caries formation occurs. Initially, decay begins with small surface roughness or subsurface demineralization, followed by cavitation and subsequent pulp involvement.
Tooth decay, one of the most common chronic diseases in childhood, negatively impacts the quality of life when left untreated, leading to problems such as pain, abscess formation, tooth loss, nutritional deficiencies, and speech disorders. To prevent early loss of primary teeth and maintain the health of the oral and surrounding tissues, restorative or endodontic treatments are applied. Treatment methods for deep dentin caries in primary teeth include indirect pulp capping, direct pulp capping, and amputation, with amputation being the most commonly used vital pulp therapy. Amputation is indicated when the pulp is either healthy or reversibly damaged and shows no signs of pulp degeneration, and the pulp becomes exposed during caries removal due to decay or mechanical causes. The goal of treatment is to preserve the vitality of the radicular pulp, control pain and inflammation, and maintain the tooth until its physiological exfoliation time. The selection of appropriate materials and techniques for amputation therapy is of critical importance. Although several studies have investigated the success of amputation materials and techniques, the ideal amputation material has not yet been defined. The ideal material and technique should be bactericidal, harmless to the pulp and surrounding tissues, support the healing of the root pulp, and contribute to the preservation of remaining tissues without affecting physiological root resorption. Additionally, factors such as cost and ease of application should also be considered in material selection. Therefore, efforts to identify the ideal amputation material continue.
The aim of this study is to evaluate the clinical and radiographic success of Theracal PT®, ProRoot® MTA, and Neoputty® MTA, and to examine the relationship between these outcomes and factors such as age, gender, the position of the tooth in the arch, and the presence of provoked pain prior to treatment.
The following hypotheses were proposed in our study:
Hypothesis 1: There is no difference in the 12-month clinical and radiographic success rates of primary tooth amputation treatments performed using Neoputty® MTA, ProRoot® MTA, and Theracal PT®.
Hypothesis 2: The 12-month clinical and radiographic success of amputation treatments performed using Neoputty® MTA, ProRoot® MTA, and Theracal PT® is not influenced by age, gender, the position of the tooth in the arch, or the presence of provoked pain prior to treatment.
This study was conducted in accordance with the Ataturk University Faculty of Medicine Ethics Committee approval (Date: 30.03.2023/ Session no:02/ Decision no:04) and guidelines of the Helsinki Declaration. The study was supported by the Scientific Research Projects Coordination Unit of Atatürk University under project number TDH-2023-13045. In this study, the teeth to be treated were randomly assigned using stratified randomization, ensuring an equal number of teeth in each study group. The research design was based on a parallel groups model. When multiple teeth from the same patient participated in the study, randomization was also applied for the other materials to be used. Patient selection, examination, treatment, and follow-up processes were carried out by a single researcher undergoing specialty training in the Department of Pediatric Dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NeoPutty MTA | Experimental | Procedure: Neoputty MTA Pulpotomy Treatment, Procedure: Stainless Steel Crown ApplicationA ready-to-use putty-form Neoputty® MTA with a minimum piston length of 1.5 mm was placed on the pulp chamber floor using a sterile dental spatula. The material was adapted to the canal orifices with the aid of a cotton pellet that had been lightly moistened with sterile saline. |
| ProRoot MTA | Experimental | Procedure: ProRoot MTA Pulpotomy Treatment, Procedure: Stainless Steel Crown ApplicationUsing a sterile glass and spatula, an adequate amount of powder and liquid was mixed for approximately 1 minute until a homogeneous consistency was achieved, following the manufacturer's recommendations. The ProRoot® MTA, prepared to a putty-like consistency, was transferred to the pulp chamber using a sterile dental spatula and adapted to the canal orifices with the aid of a cotton pellet. |
| Theracal PT | Experimental | Procedure: Theracal PT Pulpotomy Treatment, Procedure: Stainless Steel Crown ApplicationThe TheraCal PT® package contains a 4 g tube and 10 single-use mixing tips. One of the disposable mixing tips was attached to the tube, and the material was mixed within the tip by pressing the plunger. The material was then directly applied to the pulp chamber. Adaptation of the material to the canal orifices was verified using a sterile cement applicator. Polymerization was performed for 10 seconds using a Woodpecker LED B (Guilin Woodpecker Medical Instrument Co., Ltd., China) curing light device, following the manufacturer's instructions. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Deep dentin caries,
- Lamina dura and periodontal interval can be observed normally,
- 2/3 of the root length is present,
- The permanent tooth germ below is present and its position is normal,
- If there is a history of provoked pain (the type of pain that goes away when the stimulus is removed),
Key exclusion criteria (11 listed)
- Lesions in the inter-root and periapical region,
- Pathological external or internal root resorption,
- Canal calcification,
- Deformities such as taurodontism,
- Spontaneous pain or night pain,
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 |
|---|---|---|
| Neoputty MTA Pulpotomy TreatmentAll caries were removed before entering the pulp chamber. Once all caries were removed, a carbide bur was used under copious water spray to expose the pulp chamber.Coronal pulp is removed with a round bur on a slow speed handpiece. Hemostasis was achieved by applying a cotton pellet moistened with sterile saline for no more than 5 minutes. After achieving hemostasis, Neoputty MTA was placed. | Procedure or surgery | NeoPutty MTA |
| ProRoot MTA Pulpotomy TreatmentAll caries were removed before entering the pulp chamber. Once all caries were removed, a carbide bur was used under copious water spray to expose the pulp chamber.Coronal pulp is removed with a round bur on a slow speed handpiece. Hemostasis was achieved by applying a cotton pellet moistened with sterile saline for no more than 5 minutes. After achieving hemostasis, ProRoot MTA was placed. | Procedure or surgery | ProRoot MTA |
| Theracal PT Pulpotomy TreatmentAll caries were removed before entering the pulp chamber. Once all caries were removed, a carbide bur was used under copious water spray to expose the pulp chamber.Coronal pulp is removed with a round bur on a slow speed handpiece. Hemostasis was achieved by applying a cotton pellet moistened with sterile saline for no more than 5 minutes. After achieving hemostasis, Theracal PT was placed. | Procedure or surgery | Theracal PT |
| Stainless Steel Crown ApplicationAfter pulpotomy treatment, the pulpotomy material was covered using a capsule-form glass ionomer (EQUIA Forte®, GC, Tokyo, Japan). In the same session, preparation was performed for the placement of a stainless steel crown (SSC), and an appropriately sized SSC (3M ESPE, Seefeld, Germany) was selected based on visual estimation. After trial fitting on the tooth, the crown was cemented using a capsule-form glass ionomer (Riva, SDI Ltd., Victoria, Australia). | Procedure or surgery | NeoPutty MTA, ProRoot MTA, Theracal PT |
Primary outcome
Clinical Success
Time frame: 1 Month - 1 Year
No spontaneous, provoked (developing due to a stimulus) or night pain complaints. No sensitivity to percussion or palpation. No pathological mobility in the tooth. No abscess or fistula in the tooth. If any of these findings are detected, the treatment is considered clinically unsuccessful.
Radiographic Success
Time frame: 3 Month - 1 Year
No internal or external root resorption. No periapical or inter-root lesion. No widening of the periodontal space. If any of these findings are detected, the treatment is considered radiographically unsuccessful.
4 secondary outcomes
The Impact of Patient's Age on 12-Month Radiographic Success of Treatment.
Time frame: From treatment to the end of 12 months
The Impact of Patient's Gender on 12-Month Radiographic Success of Treatment.
Time frame: From treatment to the end of 12 months
The Impact of Tooth Position in the Dental Arch on the 12-Month Radiographic Success of Treatment
Time frame: From treatment to the end of 12 months
The Impact of Pre-Treatment Provoked Pain on the 12-Month Radiographic Success of Treatment.
Time frame: From treatment to the end of 12 months
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 18 Mar 2025.
- Background: PubMed 34321144Cordell S, Kratunova E, Marion I, Alrayyes S, Alapati SB. A Randomized Controlled Trial Comparing the Success of Mineral Trioxide Aggregate and Ferric Sulfate as Pulpotomy Medicaments for Primary Molars. J Dent Child (Chic). 2021 May 15;88(2):120-128.
- Background: PubMed 33772121Waterhouse P. Are different pulp treatment techniques and associated medicaments effective for the treatment of extensive decay in primary teeth? Evid Based Dent. 2021 Jan;22(1):12-13. doi: 10.1038/s41432-021-0162-6.
- Background: PubMed 24351693Celik B, Atac AS, Cehreli ZC, Uysal S. A randomized trial of mineral trioxide aggregate cements in primary tooth pulpotomies. J Dent Child (Chic). 2013 Sep-Dec;80(3):126-32.
- Background: PubMed 36890738Wassel M, Hamdy D, Elghazawy R. Evaluation of four vital pulp therapies for primary molars using a dual-cured tricalcium silicate (TheraCal PT): one-year results of a non-randomized clinical trial. J Clin Pediatr Dent. 2023 Mar;47(2):10-22. doi: 10.22514/jocpd.2023.004. Epub 2023 Mar 3.
- Derived from this study: PubMed 41857596Yucel R, Sengul F. Clinical and radiographic outcomes of three calcium silicate-based cements in primary tooth pulpotomy: a randomized clinical trial. BMC Oral Health. 2026 Mar 19;26(1):928. doi: 10.1186/s12903-026-08129-5.
- 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.
Fatih Şengül, Phd principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoputty MTA Pulpotomy Treatment, ProRoot MTA Pulpotomy Treatment and Theracal PT Pulpotomy Treatment in people with Pulpotomy, run by Ataturk 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 9 inclusion and 11 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 18 Mar 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 (time frame: 1 Month - 1 Year). 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 NCT06874062, which also lists 5 linked publications.
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 18 Mar 2025.