Pulpitis - IrreversibleNCT07660549
TheraCal Materials Versus MTA in Full Pulpotomy
A study testing Mineral Trioxide Aggregate (MTA), Theracal LC and TheraCal PT in people with Pulpitis - Irreversible, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized clinical trial is to compare the clinical performance of three pulp capping materials used in full pulpotomy procedures in mature mandibular molars with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Mineral Trioxide Aggregate (MTA), Theracal LC and TheraCal PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2024to 6 Apr 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring full pulpotomy treatment in mandibular first or second permanent molars diagnosed with symptomatic irreversible pulpitis.
- Mandibular first or second permanent molars with a preoperative Visual Analogue Scale (VAS) pain score ≥4, indicating moderate or severe pain.
- Vital mandibular first or second permanent molars showing positive responses to both cold and electric pulp tests.
- Teeth with deep carious lesions indicated for vital pulp therapy.
- Teeth with no radiographic evidence of periapical pathology.
- Patients who had not taken analgesics or antibiotics within the 24 hours preceding the procedure.
Who cannot join
- Non-vital mandibular permanent molars showing negative responses to cold or electric pulp tests.
- Non-restorable teeth.
- Teeth with root caries, open apex, pulp calcification, internal or external resorption, or periodontal involvement.
- Mandibular first or second permanent molars with poor periodontal status, defined as periodontal pocket depth >4 mm.
- Teeth with radiographic evidence of periapical pathology.
- Patients with systemic conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, chronic kidney disease, hematological disorders, or a history of chemotherapy or radiotherapy.
- Patients with contraindications to full pulpotomy treatment or local anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can TheraCal LC and TheraCal PT Match MTA in Full Pulpotomy? A Twelve-Month Randomized Clinical Trial in Permanent Molars With Symptomatic Irreversible Pulpitis
The goal of this randomized clinical trial is to compare the clinical performance of three pulp capping materials used in full pulpotomy procedures in mature mandibular molars with symptomatic irreversible pulpitis.
The main questions it aims to answer are:
Read more
- Does full pulpotomy using mineral trioxide aggregate (MTA) provide favorable postoperative pain control and 12-month clinical success?
- Does full pulpotomy using TheraCal LC provide comparable postoperative pain control and 12-month clinical success to MTA?
- Does full pulpotomy using TheraCal PT provide comparable postoperative pain control and 12-month clinical success to MTA?
Participants will undergo full pulpotomy treatment in mandibular first or second molars diagnosed with symptomatic irreversible pulpitis. After removal of the coronal pulp tissue and achievement of hemostasis, teeth will be randomly assigned to one of three treatment groups.
In the MTA group, the exposed radicular pulp tissue will be covered with mineral trioxide aggregate.
In the TheraCal LC group, the exposed radicular pulp tissue will be covered with light-cured resin-modified calcium silicate material.
In the TheraCal PT group, the exposed radicular pulp tissue will be covered with dual-cured resin-modified calcium silicate material.
Postoperative pain intensity, analgesic intake, and 12-month clinical outcomes will be compared among the three groups.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Mineral Trioxide Aggregate (MTA), Theracal LC, TheraCal PT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral Trioxide Aggregate (MTA)Other
In the MTA group, after full pulpotomy and achievement of hemostasis, the exposed radicular pulp tissue was covered with mineral trioxide aggregate. The material was placed over the pulp surface at a thickness of approximately 2-4 mm and gently condensed.
Theracal LCOther
In the TheraCal LC group, after full pulpotomy and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal LC, a light-cured resin-modified calcium silicate material. The material was applied in increments not exceeding 1 mm, and each increment was light-cured for 20 seconds.
TheraCal PTOther
In the TheraCal PT group, after full pulpotomy and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal PT, a dual-cured resin-modified calcium silicate material. The material was applied as a single layer at a thickness of approximately 2-3 mm and light-cured for 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| MTA Group | Active comparator | After removal of the coronal pulp tissue and achievement of hemostasis, the exposed radicular pulp tissue was covered with mineral trioxide aggregate (MTA). The material was placed over the pulp surface at a thickness of approximately 2-4 mm and gently condensed. A moist sterile cotton pellet was then placed over the material for approximately 10 minutes to allow initial setting. The tooth was subsequently restored using a standardized restorative protocol. Receives: Other: Mineral Trioxide Aggregate (MTA) |
| TheraCal LC Group | Experimental | After removal of the coronal pulp tissue and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal LC, a light-cured resin-modified calcium silicate material. The material was applied in increments not exceeding 1 mm to ensure adequate polymerization. Each increment was light-cured for 20 seconds, and the total material thickness was approximately 2-3 mm. The tooth was subsequently restored using a standardized restorative protocol. Receives: Other: Theracal LC |
| TheraCal PT Group | Experimental | After removal of the coronal pulp tissue and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal PT, a dual-cured resin-modified calcium silicate material. The material was applied as a single layer at a thickness of approximately 2-3 mm and light-cured for 20 seconds using an LED curing unit. The tooth was subsequently restored using a standardized restorative protocol. Receives: Other: TheraCal PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Assessed by Visual Analogue Scale
Postoperative pain intensity will be assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Participants will record their pain intensity at predetermined postoperative time points after full pulpotomy treatment. VAS scores will be compared among the MTA, TheraCal LC, and TheraCal PT groups.
Measured: Preoperative baseline, 24 hours, 72 hours, 7 days, and 14 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start16 Dec 2024
- Primary completion18 Jun 2025
- Study completion6 Apr 2026
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 Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Gürler, Cukurova University
- Investigators
- Koray Yılmaz, DDS, MSc, Professor, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660549
- Sponsor's protocol ID
- 06.12.2024/16
- Status last verified
- May 2026
- First submitted
- 16 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gilhotra V, Kumar T, Mittal S, Keshav V, Maakhni E, Kesarwani D. Comparative evaluation of various biomaterials as pulpotomy agents in molars with symptomatic irreversible pulpitis: A randomized single-blinded single-center control trial. J Conserv Dent Endod. 2024 Oct;27(10):1065-1072. doi: 10.4103/JCDE.JCDE_446_24. Epub 2024 Oct 5.
PubMed 39583272
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can TheraCal LC and TheraCal PT Match MTA in Full Pulpotomy? A Twelve-Month Randomized Clinical Trial in Permanent Molars With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT07660549
- Acronym / sponsor ID
- 06.12.2024/16
- Conditions
- Pulpitis - Irreversible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 22 Jun 2026 (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 the clinical performance of three pulp capping materials used in full pulpotomy procedures in mature mandibular molars with symptomatic irreversible pulpitis.
The main questions it aims to answer are:
- Does full pulpotomy using mineral trioxide aggregate (MTA) provide favorable postoperative pain control and 12-month clinical success?
- Does full pulpotomy using TheraCal LC provide comparable postoperative pain control and 12-month clinical success to MTA?
- Does full pulpotomy using TheraCal PT provide comparable postoperative pain control and 12-month clinical success to MTA?
Participants will undergo full pulpotomy treatment in mandibular first or second molars diagnosed with symptomatic irreversible pulpitis. After removal of the coronal pulp tissue and achievement of hemostasis, teeth will be randomly assigned to one of three treatment groups.
In the MTA group, the exposed radicular pulp tissue will be covered with mineral trioxide aggregate.
In the TheraCal LC group, the exposed radicular pulp tissue will be covered with light-cured resin-modified calcium silicate material.
In the TheraCal PT group, the exposed radicular pulp tissue will be covered with dual-cured resin-modified calcium silicate material.
Postoperative pain intensity, analgesic intake, and 12-month clinical outcomes will be compared among the three groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MTA Group | Active comparator | Other: Mineral Trioxide Aggregate (MTA)After removal of the coronal pulp tissue and achievement of hemostasis, the exposed radicular pulp tissue was covered with mineral trioxide aggregate (MTA). The material was placed over the pulp surface at a thickness of approximately 2-4 mm and gently condensed. A moist sterile cotton pellet was then placed over the material for approximately 10 minutes to allow initial setting. The tooth was subsequently restored using a standardized restorative protocol. |
| TheraCal LC Group | Experimental | Other: Theracal LCAfter removal of the coronal pulp tissue and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal LC, a light-cured resin-modified calcium silicate material. The material was applied in increments not exceeding 1 mm to ensure adequate polymerization. Each increment was light-cured for 20 seconds, and the total material thickness was approximately 2-3 mm. The tooth was subsequently restored using a standardized restorative protocol. |
| TheraCal PT Group | Experimental | Other: TheraCal PTAfter removal of the coronal pulp tissue and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal PT, a dual-cured resin-modified calcium silicate material. The material was applied as a single layer at a thickness of approximately 2-3 mm and light-cured for 20 seconds using an LED curing unit. The tooth was subsequently restored using a standardized restorative protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients requiring full pulpotomy treatment in mandibular first or second permanent molars diagnosed with symptomatic irreversible pulpitis.
- Mandibular first or second permanent molars with a preoperative Visual Analogue Scale (VAS) pain score ≥4, indicating moderate or severe pain.
- Vital mandibular first or second permanent molars showing positive responses to both cold and electric pulp tests.
- Teeth with deep carious lesions indicated for vital pulp therapy.
- Teeth with no radiographic evidence of periapical pathology.
Key exclusion criteria (7 listed)
- Non-vital mandibular permanent molars showing negative responses to cold or electric pulp tests.
- Non-restorable teeth.
- Teeth with root caries, open apex, pulp calcification, internal or external resorption, or periodontal involvement.
- Mandibular first or second permanent molars with poor periodontal status, defined as periodontal pocket depth >4 mm.
- Teeth with radiographic evidence of periapical pathology.
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 |
|---|---|---|
| Mineral Trioxide Aggregate (MTA)In the MTA group, after full pulpotomy and achievement of hemostasis, the exposed radicular pulp tissue was covered with mineral trioxide aggregate. The material was placed over the pulp surface at a thickness of approximately 2-4 mm and gently condensed. | Other | MTA Group |
| Theracal LCIn the TheraCal LC group, after full pulpotomy and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal LC, a light-cured resin-modified calcium silicate material. The material was applied in increments not exceeding 1 mm, and each increment was light-cured for 20 seconds. | Other | TheraCal LC Group |
| TheraCal PTIn the TheraCal PT group, after full pulpotomy and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal PT, a dual-cured resin-modified calcium silicate material. The material was applied as a single layer at a thickness of approximately 2-3 mm and light-cured for 20 seconds. | Other | TheraCal PT Group |
Primary outcome
Postoperative Pain Intensity Assessed by Visual Analogue Scale
Time frame: Preoperative baseline, 24 hours, 72 hours, 7 days, and 14 days after treatment
Postoperative pain intensity will be assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Participants will record their pain intensity at predetermined postoperative time points after full pulpotomy treatment. VAS scores will be compared among the MTA, TheraCal LC, and TheraCal PT groups.
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 25 Jun 2026.
- Background: PubMed 39583272Gilhotra V, Kumar T, Mittal S, Keshav V, Maakhni E, Kesarwani D. Comparative evaluation of various biomaterials as pulpotomy agents in molars with symptomatic irreversible pulpitis: A randomized single-blinded single-center control trial. J Conserv Dent Endod. 2024 Oct;27(10):1065-1072. doi: 10.4103/JCDE.JCDE_446_24. Epub 2024 Oct 5.
- Individual participant dataSharing planned: No
Related trials for Pulpitis - Irreversible
Not yet recruitingPhase 1/2
Effect of Temperature Elevation on the Antimicrobial Efficacy of Two Root Canal Irrigants in Primary Root Canal Infections: A Randomized Controlled Clinical Trial
Irreversible Pulpitis
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Recruiting
Effect of Menstrual Phase on the Anesthetic Efficacy
Pulpitis - Irreversible
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
Not yet recruiting
Anesthetic Effectiveness of Mental/Incisive Nerve Block Versus Inferior Nerve Block Using 4% Articaine and 2% Lidocaine in Mandibular First and Second Premolars With Symptomatic Irreversible Pulpitis.
Pain
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.
Koray Yılmaz, DDS, MSc, Professor principal investigator
Cukurova 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 Mineral Trioxide Aggregate (MTA), Theracal LC and TheraCal PT in people with Pulpitis - Irreversible, run by Cukurova 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 6 inclusion and 7 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 25 Jun 2026. 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?
Postoperative Pain Intensity Assessed by Visual Analogue Scale (time frame: Preoperative baseline, 24 hours, 72 hours, 7 days, and 14 days after treatment). 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 NCT07660549, 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 25 Jun 2026.