Vital Pulp TherapiesMTANCT06973057
Direct Pulp Capping Versus Pulpotomy for Primary Molars
A study testing Pulpotomy and Direct pulp capping (DPC) in people with Vital Pulp Therapies, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
Dental caries is one of the most prevalent chronic diseases worldwide. Interventions for treating deep carious lesions in teeth with no history of pain or teeth with reversible pulpitis are referred to as vital pulp therapy; these include indirect pulp treatment (IPC), direct pulp capping (DPC), and pulpotomy. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Pulp Therapies
- What is being tested?
- Pulpotomy and Direct pulp capping (DPC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJordan
- Study dates
- 1 Oct 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy patients.
- Age 4-10 years.
- Primary molar with deep caries present bilaterally.
- Teeth should be restorable.
- Clinically normal asymptomatic tooth or symptoms of reversible pulpitis (No history of pain or provoked pain subsides upon removal of the stimulus).
- Radiographically: caries in the inner half of the dentin approaching the pulp.
Who cannot join
- History of spontaneous pain.
- Soft and hard tissue pathology.
- Mobility or exfoliating tooth.
- No pulp exposure after caries excavation.
- Inability to achieve hemostasis after 6 minutes.
- Radiographically: Root resorption exceeding 1/3 of the root, apical pathology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Direct Pulp Capping Versus Pulpotomy Using Neo MTA for Carious Primary Molars: a Split Mouth Randomized Clinical Trial
Dental caries is one of the most prevalent chronic diseases worldwide. Interventions for treating deep carious lesions in teeth with no history of pain or teeth with reversible pulpitis are referred to as vital pulp therapy; these include indirect pulp treatment (IPC), direct pulp capping (DPC), and pulpotomy. Pulpotomy is considered invasive when treating exposed primary vital pulps due to caries. Less invasive vital pulp treatment methods such as DPC might, therefore, be preferable, as they reduce chair time, less tooth structure removal and a crown might not always be a necessary permanent restoration. The aim of this clinical study is to evaluate the clinical and radiographic outcomes of DPC when compared to pulpotomy in primary molars with carious pulp exposure.
Read the detailed description
Aim: The aim of this study is to evaluate the clinical and radiographic outcomes of direct pulp capping (DPC) when compared to pulpotomy in primary molars with carious pulp exposure using a calcium silicate-based material: neo mineral trioxide aggregate (Neo MTA).
Methods: The study will be a split mouth randomized clinical trial including children between 4-9 years old. Patients will be allocated into two treatment groups; one group will start with DPC first followed by pulpotomy on the second visit, and vice versa for the second group. The time interval between both visits will be 1-2 weeks. The pulp medicament capping material (neo MTA) will be applied over the exposure site, and then tooth will be restored with glass ionomer cement and then a crown will be placed. Cases will be followed up to 24 months after initial treatment.
- Conditions
- Vital Pulp Therapies
- Being tested
- Pulpotomy, Direct pulp capping (DPC)
- Keywords
- Vital Pulp therapies, Direct pulp capping, Pulpotomy, Neo MTA, Primary molars, Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
The entire coronal pulp will be amputated to the level of canal orifices, after hemostasis, NeoMTA will be placed, then tooth will be restored with glass ionomer cement, and the tooth will be subsequently restored with a crown.
Direct pulp capping (DPC)Procedure or surgery
At the exposure site hemostasis will be achieved, neo MTA will be placed, then tooth will be restored with glass ionomer cement, and the tooth will be subsequently restored with a crown.
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Active comparator | The entire coronal pulp will be amputated. Receives: Procedure: Pulpotomy |
| Direct pulp capping | Active comparator | The exposure site will be left intact, no amputation of pulp tissue. Receives: Procedure: Direct pulp capping (DPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
No post-treatment signs or symptoms such as sensitivity, pain, mobility or swelling should be evident.
Measured: 24 months
Radiographic success
No radiographic evidence of pathologic external or internal root resorption, periapical or furcation radiolucency.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Oct 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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 Vital Pulp TherapiesStudies of the same condition, open and under way.
- 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
- A split mouth randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- OLA Al-Batayneh, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973057
- Sponsor's protocol ID
- 341-2023
- Acronym
- MTA
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dimitraki D, Papageorgiou SN, Kotsanos N. Direct pulp capping versus pulpotomy with MTA for carious primary molars: a randomised clinical trial. Eur Arch Paediatr Dent. 2019 Oct;20(5):431-440. doi: 10.1007/s40368-019-00419-7. Epub 2019 Feb 20.
PubMed 30788777Alsanouni M, Bawazir OA. A Randomized Clinical Trial of NeoMTA Plus in Primary Molar Pulpotomies. Pediatr Dent. 2019 Mar 15;41(2):107-111.
PubMed 30992107ElSebaai A, Wahba AH, Grawish ME, Elkalla IH. Calcium Hydroxide Paste, Mineral Trioxide Aggregate, and Formocresol as Direct Pulp Capping Agents in Primary Molars: A Randomized Controlled Clinical Trial. Pediatr Dent. 2022 Nov 15;44(6):411-417.
PubMed 36947754Chatzidimitriou K, Vadiakas G, Koletsi D. Direct pulp capping in asymptomatic carious primary molars using three different pulp capping materials: a prospective clinical trial. Eur Arch Paediatr Dent. 2022 Oct;23(5):803-811. doi: 10.1007/s40368-022-00720-y. Epub 2022 Jul 2.
PubMed 35780237Canoglu E, Gungor HC, Uysal S. Direct Pulp Capping of Primary Molars with Calcium Hydroxide or MTA Following Hemorrhage Control with Different Medicaments: Randomized Clinical Trial. Pediatr Dent. 2022 May 15;44(3):167-173.
PubMed 35799339
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Pulp Capping Versus Pulpotomy Using Neo MTA for Carious Primary Molars: a Split Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06973057
- Acronym / sponsor ID
- MTA / 341-2023
- Conditions
- Vital Pulp Therapies
- Keywords
- Vital Pulp therapies, Direct pulp capping, Pulpotomy, Neo MTA, Primary molars, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 May 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.
Dental caries is one of the most prevalent chronic diseases worldwide. Interventions for treating deep carious lesions in teeth with no history of pain or teeth with reversible pulpitis are referred to as vital pulp therapy; these include indirect pulp treatment (IPC), direct pulp capping (DPC), and pulpotomy. Pulpotomy is considered invasive when treating exposed primary vital pulps due to caries. Less invasive vital pulp treatment methods such as DPC might, therefore, be preferable, as they reduce chair time, less tooth structure removal and a crown might not always be a necessary permanent restoration. The aim of this clinical study is to evaluate the clinical and radiographic outcomes of DPC when compared to pulpotomy in primary molars with carious pulp exposure.
Detailed description
Aim: The aim of this study is to evaluate the clinical and radiographic outcomes of direct pulp capping (DPC) when compared to pulpotomy in primary molars with carious pulp exposure using a calcium silicate-based material: neo mineral trioxide aggregate (Neo MTA).
Methods: The study will be a split mouth randomized clinical trial including children between 4-9 years old. Patients will be allocated into two treatment groups; one group will start with DPC first followed by pulpotomy on the second visit, and vice versa for the second group. The time interval between both visits will be 1-2 weeks. The pulp medicament capping material (neo MTA) will be applied over the exposure site, and then tooth will be restored with glass ionomer cement and then a crown will be placed. Cases will be followed up to 24 months after initial treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A split mouth randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Active comparator | Procedure: PulpotomyThe entire coronal pulp will be amputated. |
| Direct pulp capping | Active comparator | Procedure: Direct pulp capping (DPC)The exposure site will be left intact, no amputation of pulp tissue. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy patients.
- Age 4-10 years.
- Primary molar with deep caries present bilaterally.
- Teeth should be restorable.
- Clinically normal asymptomatic tooth or symptoms of reversible pulpitis (No history of pain or provoked pain subsides upon removal of the stimulus).
Key exclusion criteria (6 listed)
- History of spontaneous pain.
- Soft and hard tissue pathology.
- Mobility or exfoliating tooth.
- No pulp exposure after caries excavation.
- Inability to achieve hemostasis after 6 minutes.
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 |
|---|---|---|
| PulpotomyThe entire coronal pulp will be amputated to the level of canal orifices, after hemostasis, NeoMTA will be placed, then tooth will be restored with glass ionomer cement, and the tooth will be subsequently restored with a crown. | Procedure or surgery | Pulpotomy |
| Direct pulp capping (DPC)At the exposure site hemostasis will be achieved, neo MTA will be placed, then tooth will be restored with glass ionomer cement, and the tooth will be subsequently restored with a crown. | Procedure or surgery | Direct pulp capping |
Primary outcome
Clinical success
Time frame: 24 months
No post-treatment signs or symptoms such as sensitivity, pain, mobility or swelling should be evident.
Radiographic success
Time frame: 24 months
No radiographic evidence of pathologic external or internal root resorption, periapical or furcation radiolucency.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Results publication: PubMed 30788777Dimitraki D, Papageorgiou SN, Kotsanos N. Direct pulp capping versus pulpotomy with MTA for carious primary molars: a randomised clinical trial. Eur Arch Paediatr Dent. 2019 Oct;20(5):431-440. doi: 10.1007/s40368-019-00419-7. Epub 2019 Feb 20.
- Results publication: PubMed 30992107Alsanouni M, Bawazir OA. A Randomized Clinical Trial of NeoMTA Plus in Primary Molar Pulpotomies. Pediatr Dent. 2019 Mar 15;41(2):107-111.
- Results publication: PubMed 36947754ElSebaai A, Wahba AH, Grawish ME, Elkalla IH. Calcium Hydroxide Paste, Mineral Trioxide Aggregate, and Formocresol as Direct Pulp Capping Agents in Primary Molars: A Randomized Controlled Clinical Trial. Pediatr Dent. 2022 Nov 15;44(6):411-417.
- Results publication: PubMed 35780237Chatzidimitriou K, Vadiakas G, Koletsi D. Direct pulp capping in asymptomatic carious primary molars using three different pulp capping materials: a prospective clinical trial. Eur Arch Paediatr Dent. 2022 Oct;23(5):803-811. doi: 10.1007/s40368-022-00720-y. Epub 2022 Jul 2.
- Results publication: PubMed 35799339Canoglu E, Gungor HC, Uysal S. Direct Pulp Capping of Primary Molars with Calcium Hydroxide or MTA Following Hemorrhage Control with Different Medicaments: Randomized Clinical Trial. Pediatr Dent. 2022 May 15;44(3):167-173.
- Pulp Therapy for Primary and Immature Permanent TeethLink provided by the sponsor.
- 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.
OLA Al-Batayneh principal investigator
Jordan University of Science and Technology
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 and Direct pulp capping (DPC) in people with Vital Pulp Therapies, run by King Abdullah University Hospital at 1 site in Jordan.
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 6 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: enrolling by invitation, as of the sponsor's last update on 15 May 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 Jordan. 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?
This study is still under way. Results are not available in the source record yet.
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: 24 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?
On the ClinicalTrials.gov record for NCT06973057, 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 15 May 2025.