Dental CariesNCT07769697
Comparative Clinical and Radiographic Evaluation of Different Pulpotomy Materials in Primary Molars
A study testing Pulpotomy, Mineral Trioxide Aggregate (MTA) and Calcium-Enriched Mixture (CEM) in people with Dental Caries and Pulp Exposure, Dental, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial compared the clinical and radiographic outcomes of ferric sulfate (FS), mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM), and TheraCal PT used for pulpotomy in primary molars. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Dental Caries, Pulp Exposure, Dental, Primary Teeth
- What is being tested?
- Pulpotomy, Mineral Trioxide Aggregate (MTA) and Calcium-Enriched Mixture (CEM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2021to 21 Oct 2022
- 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
- No healthy volunteers
- Child
Who may be able to join
- Patient-related criteria
- Children aged 4-9 years.
- Healthy children with no systemic disease.
- No regular medication use.
- No known allergy to the study materials.
- Cooperative patients able to undergo dental treatment.
Show all 14Show fewer
- Written informed consent obtained from the parent or legal guardian. Tooth-related criteria
- Restorable primary molars with deep carious lesions requiring pulpotomy.
- Clinical signs and symptoms consistent with reversible pulpitis (no spontaneous, lingering, or nocturnal pain).
- No tenderness to percussion or pathological mobility.
- No swelling or sinus tract associated with the study tooth.
- Hemostasis achieved within 5 minutes after coronal pulp amputation.
- No radiographic evidence of internal or external root resorption, furcation or periapical radiolucency, periodontal ligament widening, or pulp calcification.
- At least two-thirds of the root length remaining.
Who cannot join
- Failure to meet any of the inclusion criteria.
- No pulp exposure or pulp exposure ≤1 mm after complete caries removal.
- Persistent pain during caries removal despite adequate local anesthesia, suggestive of advanced pulpal inflammation.
- Excessive pulpal bleeding that could not be controlled within 5 minutes.
- Presence of purulent exudate from the pulp.
- Loss of patient cooperation during treatment.
- Withdrawal of parental consent or inability to attend follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of the Clinical and Radiographic Outcomes of Pulpotomy Materials in Primary Molars: A Randomized Clinical Trial
This randomized clinical trial compared the clinical and radiographic outcomes of ferric sulfate (FS), mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM), and TheraCal PT used for pulpotomy in primary molars. A total of 140 restorable primary molars from children aged 4 to 9 years were randomly allocated to four treatment groups. Clinical and radiographic evaluations were performed at 3, 6, 9, and 12 months to compare treatment success and failure among the four pulpotomy materials.
Read the detailed description
Vital pulpotomy is a well-established treatment for preserving the vitality of primary molars with carious pulp exposure when the radicular pulp is considered healthy. Several pulpotomy materials have been proposed, including ferric sulfate (FS), mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM), and TheraCal PT. Although FS, MTA, and CEM have been extensively investigated, clinical evidence regarding the performance of TheraCal PT in primary molar pulpotomy remains limited.
This study was designed as a single-center, parallel-group, randomized controlled clinical trial to compare the clinical and radiographic outcomes of FS, MTA, CEM, and TheraCal PT used for pulpotomy in primary molars. A total of 140 restorable primary molars from children aged 4 to 9 years were randomly allocated to one of four treatment groups. Following pulpotomy, all teeth were restored according to the study protocol and evaluated clinically and radiographically at 3, 6, 9, and 12 months.
The primary outcome measure was the 12-month clinical and radiographic success of pulpotomy. Secondary outcomes included treatment failure patterns and the influence of tooth type, arch, and restoration type on treatment success.
- Being tested
- Pulpotomy, Mineral Trioxide Aggregate (MTA), Calcium-Enriched Mixture (CEM), Ferric Sulfate, TheraCal PT
- Keywords
- Primary teeth Pulpotomy, Primary Molars, Vital Pulp Therapy, Mineral Trioxide Aggregate, Calcium-Enriched Mixture, TheraCal PT, Ferric Sulfate
- Medical subject headings
- Dental Caries, Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Pulpotomy is a vital pulp therapy procedure in which the coronal pulp tissue is removed while preserving the vitality of the radicular pulp. Following hemostasis, the assigned pulpotomy material was applied according to the study protocol before definitive restoration of the tooth.
Mineral Trioxide Aggregate (MTA)Other
Mineral trioxide aggregate (MTA) was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
Calcium-Enriched Mixture (CEM)Other
Calcium-enriched mixture (CEM) was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
Ferric SulfateOther
Ferric sulfate was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
TheraCal PTOther
TheraCal PT was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| MTA Pulpotomy | Active comparator | Mineral Trioxide Aggregate Receives: Procedure: Pulpotomy; Other: Mineral Trioxide Aggregate (MTA) |
| CEM Pulpotomy | Active comparator | Calcium-Enriched Mixture (CEM) Receives: Procedure: Pulpotomy; Other: Calcium-Enriched Mixture (CEM) |
| Ferric Sulfate Pulpotomy | Active comparator | Ferric Sulfate Receives: Procedure: Pulpotomy; Other: Ferric Sulfate |
| TheraCal PT Pulpotomy | Active comparator | TheraCal PT Receives: Procedure: Pulpotomy; Other: TheraCal PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical success at 12 months
Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 12-month follow-up.
Measured: 12 months
Rate of radiographic success at 12 months
Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 12-month follow-up.
Measured: 12 months
Secondary outcomes (14)
Rate of clinical success at 3 months
Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 3-month follow-up.
Measured: 3 months
Rate of clinical success at 6 months
Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 6-month follow-up.
Measured: 6 months
Rate of clinical success at 9 months
Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 9-month follow-up.
Measured: 9 months
Rate of radiographic success at 3 months
Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 3-month follow-up.
Measured: 3 months
Rate of radiographic success at 6 months
Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 6-month follow-up.
Measured: 6 months
Rate of radiographic success at 9 months
Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 9-month follow-up.
Measured: 9 months
Rate of clinical failure patterns at 12 months
Clinical failure patterns included spontaneous pain, tenderness to percussion, pathological mobility, swelling, and sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars exhibiting each clinical failure pattern at the 12-month follow-up.
Measured: 12 months
Rate of radiographic failure patterns at 12 months
Radiographic failure patterns included periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars exhibiting each radiographic failure pattern at the 12-month follow-up.
Measured: 12 months
Rate of clinical treatment failure according to tooth type at 12 months
Clinical treatment failure was defined as the presence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars with clinical treatment failure according to tooth type (first or second primary molar).
Measured: 12 months
Rate of radiographic treatment failure according to tooth type at 12 months
Radiographic treatment failure was defined as the presence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, or periapical radiolucency. The outcome will be reported as the percentage of treated primary molars with radiographic treatment failure according to tooth type (first or second primary molar).
Measured: 12 months
Rate of clinical treatment failure according to dental arch at 12 months
Clinical treatment failure was defined as the presence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars with clinical treatment failure according to dental arch (maxillary or mandibular).
Measured: 12 months
Rate of radiographic treatment failure according to dental arch at 12 months
Radiographic treatment failure was defined as the presence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, or periapical radiolucency. The outcome will be reported as the percentage of treated primary molars with radiographic treatment failure according to dental arch (maxillary or mandibular).
Measured: 12 months
Rate of clinical treatment failure according to restoration type at 12 months
Clinical treatment failure was defined as the presence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars with clinical treatment failure according to restoration type (stainless steel crown or composite resin restoration).
Measured: 12 months
Rate of radiographic treatment failure according to restoration type at 12 months
Radiographic treatment failure was defined as the presence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, or periapical radiolucency. The outcome will be reported as the percentage of treated primary molars with radiographic treatment failure according to restoration type (stainless steel crown or composite resin restoration).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start21 Oct 2021
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Participants were randomly assigned to one of four parallel treatment groups according to the pulpotomy material used (ferric sulfate, MTA, CEM, or TheraCal PT). Clinical and radiographic outcomes were evaluated over a 12-month follow-up period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şefika Nur Özden Işik, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769697
- Sponsor's protocol ID
- 2021/161
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request to the corresponding author. The study protocol and statistical analysis plan will also be available. Data will be shared for the purpose of scientific research after publication.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Clinical and Radiographic Outcomes of Pulpotomy Materials in Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07769697
- Acronym / sponsor ID
- 2021/161
- Keywords
- Primary teeth Pulpotomy, Primary Molars, Vital Pulp Therapy, Mineral Trioxide Aggregate, Calcium-Enriched Mixture, TheraCal PT, Ferric Sulfate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 18 Aug 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.
This randomized clinical trial compared the clinical and radiographic outcomes of ferric sulfate (FS), mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM), and TheraCal PT used for pulpotomy in primary molars. A total of 140 restorable primary molars from children aged 4 to 9 years were randomly allocated to four treatment groups. Clinical and radiographic evaluations were performed at 3, 6, 9, and 12 months to compare treatment success and failure among the four pulpotomy materials.
Detailed description
Vital pulpotomy is a well-established treatment for preserving the vitality of primary molars with carious pulp exposure when the radicular pulp is considered healthy. Several pulpotomy materials have been proposed, including ferric sulfate (FS), mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM), and TheraCal PT. Although FS, MTA, and CEM have been extensively investigated, clinical evidence regarding the performance of TheraCal PT in primary molar pulpotomy remains limited.
This study was designed as a single-center, parallel-group, randomized controlled clinical trial to compare the clinical and radiographic outcomes of FS, MTA, CEM, and TheraCal PT used for pulpotomy in primary molars. A total of 140 restorable primary molars from children aged 4 to 9 years were randomly allocated to one of four treatment groups. Following pulpotomy, all teeth were restored according to the study protocol and evaluated clinically and radiographically at 3, 6, 9, and 12 months.
The primary outcome measure was the 12-month clinical and radiographic success of pulpotomy. Secondary outcomes included treatment failure patterns and the influence of tooth type, arch, and restoration type on treatment success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants were randomly assigned to one of four parallel treatment groups according to the pulpotomy material used (ferric sulfate, MTA, CEM, or TheraCal PT). Clinical and radiographic outcomes were evaluated over a 12-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| MTA Pulpotomy | Active comparator | Procedure: Pulpotomy, Other: Mineral Trioxide Aggregate (MTA)Mineral Trioxide Aggregate |
| CEM Pulpotomy | Active comparator | Procedure: Pulpotomy, Other: Calcium-Enriched Mixture (CEM)Calcium-Enriched Mixture (CEM) |
| Ferric Sulfate Pulpotomy | Active comparator | Procedure: Pulpotomy, Other: Ferric SulfateFerric Sulfate |
| TheraCal PT Pulpotomy | Active comparator | Procedure: Pulpotomy, Other: TheraCal PTTheraCal PT |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Patient-related criteria
- Children aged 4-9 years.
- Healthy children with no systemic disease.
- No regular medication use.
- No known allergy to the study materials.
Key exclusion criteria (7 listed)
- Failure to meet any of the inclusion criteria.
- No pulp exposure or pulp exposure ≤1 mm after complete caries removal.
- Persistent pain during caries removal despite adequate local anesthesia, suggestive of advanced pulpal inflammation.
- Excessive pulpal bleeding that could not be controlled within 5 minutes.
- Presence of purulent exudate from the pulp.
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 |
|---|---|---|
| PulpotomyPulpotomy is a vital pulp therapy procedure in which the coronal pulp tissue is removed while preserving the vitality of the radicular pulp. Following hemostasis, the assigned pulpotomy material was applied according to the study protocol before definitive restoration of the tooth. | Procedure or surgery | CEM Pulpotomy, Ferric Sulfate Pulpotomy, MTA Pulpotomy, TheraCal PT Pulpotomy |
| Mineral Trioxide Aggregate (MTA)Mineral trioxide aggregate (MTA) was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol. | Other | MTA Pulpotomy |
| Calcium-Enriched Mixture (CEM)Calcium-enriched mixture (CEM) was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol. | Other | CEM Pulpotomy |
| Ferric SulfateFerric sulfate was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol. | Other | Ferric Sulfate Pulpotomy |
| TheraCal PTTheraCal PT was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol. | Other | TheraCal PT Pulpotomy |
Primary outcome
Rate of clinical success at 12 months
Time frame: 12 months
Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 12-month follow-up.
Rate of radiographic success at 12 months
Time frame: 12 months
Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 12-month follow-up.
14 secondary outcomes
Rate of clinical success at 3 months
Time frame: 3 months
Rate of clinical success at 6 months
Time frame: 6 months
Rate of clinical success at 9 months
Time frame: 9 months
Rate of radiographic success at 3 months
Time frame: 3 months
Rate of radiographic success at 6 months
Time frame: 6 months
Rate of radiographic success at 9 months
Time frame: 9 months
Rate of clinical failure patterns at 12 months
Time frame: 12 months
Rate of radiographic failure patterns at 12 months
Time frame: 12 months
Rate of clinical treatment failure according to tooth type at 12 months
Time frame: 12 months
Rate of radiographic treatment failure according to tooth type at 12 months
Time frame: 12 months
Rate of clinical treatment failure according to dental arch at 12 months
Time frame: 12 months
Rate of radiographic treatment failure according to dental arch at 12 months
Time frame: 12 months
Rate of clinical treatment failure according to restoration type at 12 months
Time frame: 12 months
Rate of radiographic treatment failure according to restoration type at 12 months
Time frame: 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 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request to the corresponding author. The study protocol and statistical analysis plan will also be available. Data will be shared for the purpose of scientific research after publication.
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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 Pulpotomy, Mineral Trioxide Aggregate (MTA) and Calcium-Enriched Mixture (CEM) in people with Dental Caries and Pulp Exposure, Dental, run by Inonu 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 14 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 18 Aug 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?
Rate of clinical success at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.