Pulp Disease, DentalNCT06227390
Clinical and Radiographic Outcomes of Partial Pulpotomy Procedure in Primary Molars Utilizing Different Capping Materials and Different Restorative Methods
A study testing partial pulpotomy in people with Pulp Disease, Dental, run by British University In Egypt at 1 site in Egypt.
Trial summary
the goal of this clinical trial is to compare clinical and radiographic outcomes of partial pulpotomy in vital primary molars using TheraCal PT®, Biodentin® and NeoPUTTY® MTA , followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown. Read more about this study
- Who is it for?
- Ages 4 to 7 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulp Disease, Dental
- What is being tested?
- partial pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2023to 31 Aug 2025
- 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 7 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy patients aged 4-7-years old.
- Cooperative patients (Frankle scale + and ++)
- Asymptomatic primary molar with deep caries requiring vital pulp therapy
Who cannot join
- presence of any of the following:
- History of spontaneous lingering pain, swelling, or sinus tract.
- Pathological mobility.
- pain on percussion.
- Furcation or periapical radiolucency.
- pathological root resorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Outcomes of Partial Pulpotomy Procedure in Primary Molars Utilizing Different Capping Materials and Different Restorative Methods: A Randomized Clinical Trial
the goal of this clinical trial is to compare clinical and radiographic outcomes of partial pulpotomy in vital primary molars using TheraCal PT®, Biodentin® and NeoPUTTY® MTA , followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown.
Read the detailed description
- Primary teeth act as natural space maintainers for the subsequent dentition, they also aid in mastication, satisfactory esthetics and proper articulation of letters. So, it is of prime importance to maintain and preserve their vitality and function through vital pulp therapy (VPT). Ideal VPT materials would sustain pulp vitality, encourage pulp healing. Due to their biocompatibility, bioactivity, and superior sealing capacity, tricalcium silicates (TCSs), such as mineral trioxide aggregate (MTA) and Biodentine®, are currently the most widely used materials for VPT in permanent and primary teeth.Other calcium silicate-based compounds, such as TheraCal PT®, have recently been introduced to the market. TheraCal PT®, a dual-cured variation of its light-cured predecessor Theracal LC®, has improved its chemical capabilities to mitigate the potential harmful consequences of leaving un polymerized monomers.
- The best course of action for primary molars with deep carious lesions that aren't exhibiting any symptoms or indicators of irreversible pulpitis has posed challenges for years. With pulp capping and pulpotomy available as options for primary teeth, and partial pulpotomy in young permanent teeth according to the American Academy of Pediatric Dentistry (AAPD) guidelines for vital pulp therapy. A less invasive version of pulpotomy which is partial pulpotomy uses more conservative theories and biologic principles to produce better clinical results
- New iterations of calcium silicate-based materials have been created for usage as vital pulp therapy material due to their advantageous biological, physical, and mechanical qualities. Additionally, they promote growth factor production and differentiation into odontoblast like cells .
- TheraCal PT® advantages include that it has a hydrophilic matrix which releases Calcium ions. Koutroulis et al.,stated that the increased antibacterial efficacy and calcium release are strongly linked. Also, Calcium release has been linked to the biological characteristics of hydraulic cements because it promotes the differentiation potential of dental pulp cells and enhances mineralization, which results in deposition of a dentine-like barrier on the pulp's surface on the long-term. The other advantage that it increases the pH which provides anti-bacterial activity.
- there is lack of evidence in partial pulpotomy in treatment of carious primary teeth, the materials that could be used in it and necessity of using crown after it.
- this clinical trial will be performed to provide evidence based answer for treatment of primary molars using partial pulpotomy the materials that could be used in it and necessity of using crown after it. -• Children will be allocated into either one of the groups of partial pulpotomy depending on the medicament used as follows:
- Group 1A: (control group) MTA and stainless-steel crown.
- Group 1B: MTA and glass ionomer restoration.
- Group 2A: Biodentin® and stainless-steel crown.
- Group 2B: Biodentin® and glass ionomer restoration.
- Group 3A: TheraCal PT® and stainless-steel crown.
- Group 3B: TheraCal PT® and glass ionomer restoration. All of the medicaments will be applied according to the manufacturer's instructions and gently placed over the pulp tissue to a thickness of 2mm then the rest of the pulp chamber will be filled with glass ionomer cement
- Clinical follow up after 3,6,9 and12 months while radiographic follow up every 6 months.
- Parents will be asked if any complains occurred between follow up visits by phone
- Conditions
- Pulp Disease, Dental
- Being tested
- partial pulpotomy
- Keywords
- partial pulpotomy
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial pulpotomyProcedure or surgery
2-3 mm of the coronal pulp tissue is removed leaving healthy vital pulp tissue that is dressed with a dental biomaterial that maintains pulpal vitality and promotes repair
| Study group | Role | What they receive |
|---|---|---|
| MTA and stainless-steel crown | Experimental | Not described Receives: Procedure: partial pulpotomy |
| Biodentine® and stainless-steel crown | Experimental | Not described Receives: Procedure: partial pulpotomy |
| TheraCal PT® and stainless-steel crown | Experimental | Not described Receives: Procedure: partial pulpotomy |
| MTA and glass ionomer restoration | Experimental | Not described Receives: Procedure: partial pulpotomy |
| Biodentine® and glass ionomer restoration | Experimental | Not described Receives: Procedure: partial pulpotomy |
| TheraCal PT® and glass ionomer | Experimental | Not described Receives: Procedure: partial pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate and Compare clinical outcomes of TheraCal PT®, Biodentin® and NeoPUTTY®, followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown.in partial pulpotomy in vital primary molars
method of measurement: presence or absence of pain, swelling, fistula, mobility unit of measurement: yes or no
Measured: 1 year
Secondary outcomes (1)
Evaluate and compare Radiographic outcomes of TheraCal PT®, Biodentin® and NeoPUTTY® MTA, followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown in partial pulpotomy in vital primary molars
method of measurement: comparing pre and post operative radiographs unit of measurement: presence of furcation or periapical radiolucency, pathologic external root resorption, or internal resorption
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start15 Oct 2023
- Primary completion27 Aug 2025
- Study completion31 Aug 2025
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 Pulp Disease, DentalStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Elsharkawy, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227390
- Sponsor's protocol ID
- 23-005
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elsharkawy AM, Kabil NS, Metwalli N, Abd El Geleel O. Clinical and radiographic outcomes of partial pulpotomy procedure in primary molars utilising different capping materials and different sealing methods: a randomised clinical trial. Eur Arch Paediatr Dent. 2026 Jul 30. doi: 10.1007/s40368-026-01254-3. Online ahead of print.
PubMed 42530796
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Partial Pulpotomy Procedure in Primary Molars Utilizing Different Capping Materials and Different Restorative Methods: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06227390
- Acronym / sponsor ID
- 23-005
- Conditions
- Pulp Disease, Dental
- Keywords
- partial pulpotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 26 Jan 2024 (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 compare clinical and radiographic outcomes of partial pulpotomy in vital primary molars using TheraCal PT®, Biodentin® and NeoPUTTY® MTA , followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown.
Detailed description
- Primary teeth act as natural space maintainers for the subsequent dentition, they also aid in mastication, satisfactory esthetics and proper articulation of letters. So, it is of prime importance to maintain and preserve their vitality and function through vital pulp therapy (VPT). Ideal VPT materials would sustain pulp vitality, encourage pulp healing. Due to their biocompatibility, bioactivity, and superior sealing capacity, tricalcium silicates (TCSs), such as mineral trioxide aggregate (MTA) and Biodentine®, are currently the most widely used materials for VPT in permanent and primary teeth.Other calcium silicate-based compounds, such as TheraCal PT®, have recently been introduced to the market. TheraCal PT®, a dual-cured variation of its light-cured predecessor Theracal LC®, has improved its chemical capabilities to mitigate the potential harmful consequences of leaving un polymerized monomers.
- The best course of action for primary molars with deep carious lesions that aren't exhibiting any symptoms or indicators of irreversible pulpitis has posed challenges for years. With pulp capping and pulpotomy available as options for primary teeth, and partial pulpotomy in young permanent teeth according to the American Academy of Pediatric Dentistry (AAPD) guidelines for vital pulp therapy. A less invasive version of pulpotomy which is partial pulpotomy uses more conservative theories and biologic principles to produce better clinical results
- New iterations of calcium silicate-based materials have been created for usage as vital pulp therapy material due to their advantageous biological, physical, and mechanical qualities. Additionally, they promote growth factor production and differentiation into odontoblast like cells .
- TheraCal PT® advantages include that it has a hydrophilic matrix which releases Calcium ions. Koutroulis et al.,stated that the increased antibacterial efficacy and calcium release are strongly linked. Also, Calcium release has been linked to the biological characteristics of hydraulic cements because it promotes the differentiation potential of dental pulp cells and enhances mineralization, which results in deposition of a dentine-like barrier on the pulp's surface on the long-term. The other advantage that it increases the pH which provides anti-bacterial activity.
- there is lack of evidence in partial pulpotomy in treatment of carious primary teeth, the materials that could be used in it and necessity of using crown after it.
- this clinical trial will be performed to provide evidence based answer for treatment of primary molars using partial pulpotomy the materials that could be used in it and necessity of using crown after it. -• Children will be allocated into either one of the groups of partial pulpotomy depending on the medicament used as follows:
- Group 1A: (control group) MTA and stainless-steel crown.
- Group 1B: MTA and glass ionomer restoration.
- Group 2A: Biodentin® and stainless-steel crown.
- Group 2B: Biodentin® and glass ionomer restoration.
- Group 3A: TheraCal PT® and stainless-steel crown.
- Group 3B: TheraCal PT® and glass ionomer restoration. All of the medicaments will be applied according to the manufacturer's instructions and gently placed over the pulp tissue to a thickness of 2mm then the rest of the pulp chamber will be filled with glass ionomer cement
- Clinical follow up after 3,6,9 and12 months while radiographic follow up every 6 months.
- Parents will be asked if any complains occurred between follow up visits by phone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MTA and stainless-steel crown | Experimental | Procedure: partial pulpotomy |
| Biodentine® and stainless-steel crown | Experimental | Procedure: partial pulpotomy |
| TheraCal PT® and stainless-steel crown | Experimental | Procedure: partial pulpotomy |
| MTA and glass ionomer restoration | Experimental | Procedure: partial pulpotomy |
| Biodentine® and glass ionomer restoration | Experimental | Procedure: partial pulpotomy |
| TheraCal PT® and glass ionomer | Experimental | Procedure: partial pulpotomy |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy patients aged 4-7-years old.
- Cooperative patients (Frankle scale + and ++)
- Asymptomatic primary molar with deep caries requiring vital pulp therapy
Key exclusion criteria (6 listed)
- presence of any of the following:
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 |
|---|---|---|
| partial pulpotomy2-3 mm of the coronal pulp tissue is removed leaving healthy vital pulp tissue that is dressed with a dental biomaterial that maintains pulpal vitality and promotes repair | Procedure or surgery | Biodentine® and glass ionomer restoration, Biodentine® and stainless-steel crown, MTA and glass ionomer restoration, MTA and stainless-steel crown, TheraCal PT® and glass ionomer, TheraCal PT® and stainless-steel crown |
Primary outcome
Evaluate and Compare clinical outcomes of TheraCal PT®, Biodentin® and NeoPUTTY®, followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown.in partial pulpotomy in vital primary molars
Time frame: 1 year
method of measurement: presence or absence of pain, swelling, fistula, mobility unit of measurement: yes or no
1 secondary outcome
Evaluate and compare Radiographic outcomes of TheraCal PT®, Biodentin® and NeoPUTTY® MTA, followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown in partial pulpotomy in vital primary molars
Time frame: 1year
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 24 Nov 2025.
- Derived from this study: PubMed 42530796Elsharkawy AM, Kabil NS, Metwalli N, Abd El Geleel O. Clinical and radiographic outcomes of partial pulpotomy procedure in primary molars utilising different capping materials and different sealing methods: a randomised clinical trial. Eur Arch Paediatr Dent. 2026 Jul 30. doi: 10.1007/s40368-026-01254-3. Online ahead of print.
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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 partial pulpotomy in people with Pulp Disease, Dental, run by British University In Egypt at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 24 Nov 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 Egypt. 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?
Evaluate and Compare clinical outcomes of TheraCal PT®, Biodentin® and NeoPUTTY®, followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown.in partial pulpotomy in vital primary molars (time frame: 1 year). 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 NCT06227390, 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 24 Nov 2025.