Symptomatic Reversible Pulpitis (Disorder)NCT06575062
The Effect of Different Treatment Methods on the Apical Closure and Treatment Success in Permanent First Molars
A study testing Direct Pulp Capping with ProRoot MTA and Pulpotomy with ProRoot MTA in people with Symptomatic Reversible Pulpitis (Disorder), run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this thesis study is to evaluate the clinical and radiographic success of direct capping and pulpotomy applications using ProRoot MTA (mineral trioxide aggregate) in lower permanent first molars with reversible pulpitis symptoms that have not yet completed their root development. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Reversible Pulpitis (Disorder)
- What is being tested?
- Direct Pulp Capping with ProRoot MTA and Pulpotomy with ProRoot MTA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2023to 5 Jun 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages ranging from 7 to 10 years.
- Systemically healthy individuals.
- Have symptomatic reversible pulpitis characterized by pain that starts spontaneously and does not subside for a long time but does not include throbbing or night pain.
- Patients with permanent mandibular molars exhibiting open root tips, classified as Moorrees stages R½, R¾, Rc, or A½.
Who cannot join
- Children with systemic diseases.
- Presence of signs indicative of pulp necrosis, such as fistula or swelling in the buccal/lingual region.
- Tenderness upon palpation in the buccal/lingual region.
- Pain upon percussion.
- Presence of interradicular or periradicular radiolucency on radiographic examination.
- Evidence of internal or external root resorption.
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- Widening of the periodontal space.
- Teeth with caries or molar-incisor hypomineralization (MIH) that result in excessive material loss potentially leading to restoration failure.
- Patients with inflammation and hyperemia in the root pulp.
- Permanent mandibular molar teeth with closed or nearly closed root ends, classified as Moorrees stage Ac.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Dentistry
Erzurum
About this study
Official title: The Effect of Different Treatment Methods on Apical Closure and Treatment Success in Immature Permanent First Molars With Reversible Pulpitis
The purpose of this thesis study is to evaluate the clinical and radiographic success of direct capping and pulpotomy applications using ProRoot MTA (mineral trioxide aggregate) in lower permanent first molars with reversible pulpitis symptoms that have not yet completed their root development. Additionally, the study aims to assess the effects of these treatments on maturogenesis, specifically root development and apical closure.
Read the detailed description
The objective of this thesis is to investigate the effectiveness of direct capping and pulpotomy treatments using ProRoot MTA in managing reversible pulpitis in lower permanent first molars that have not yet achieved full root development. This study focuses on assessing both clinical and radiographic outcomes of these dental procedures. Specifically, it aims to determine the impact of these treatments on the natural progression of root formation and the closure of the root apex, a process known as maturogenesis. By examining these factors, the study seeks to provide a comprehensive understanding of how ProRoot MTA can be utilized to facilitate proper root development and healing in immature permanent molars affected by reversible pulpitis.
The study will test the following hypotheses:
Hypothesis 1: There is no difference between the clinical and radiographic success of direct capping and pulpotomy treatments in cases of reversible pulpal involvement of immature permanent molars.
Hypothesis 2: In cases of reversible pulpal involvement of immature permanent molars, direct capping and pulpotomy treatments have no effect on apexogenesis.
Hypothesis 3: Different root development levels of the teeth have no effect on the success of direct capping and pulpotomy treatments in cases of reversible pulpal involvement of immature permanent molars.
The main questions the study aims to answer are:
What are the clinical and radiographic outcomes at 3, 6, 12, and 18 months after treatment with direct capping and pulpotomy using ProRoot MTA.
How do these treatments affect root development and apical closure.
Participants in this study will:
Receive either direct capping or pulpotomy treatments using ProRoot MTA. Undergo clinical and radiographic evaluations at 3, 6, 12, and 18 months post-treatment.
Have their root development stages categorized according to the Moorrees classification (R½, R¾, Rc, A½) to assess the impact of treatments on maturogenesis.
The study aims to provide valuable insights into the effectiveness of ProRoot MTA in treating reversible pulpitis in immature permanent molars, contributing to improved clinical practices and patient outcomes.
Clinical Evaluation Criteria
Presence of spontaneous, long-lasting, or throbbing pain. Sensitivity to percussion and palpation. Presence of a fistula or swelling in the buccal or lingual region. Abnormal tooth mobility.
Radiological Evaluation Criteria
Widening of the periodontal space. Radiolucency in the interradicular or periradicular regions. Evidence of internal or external root resorption. Monitoring of root development stages according to the Moorrees classification. This study aims to provide valuable insights into the effectiveness of ProRoot MTA in treating reversible pulpitis in immature permanent molars, contributing to improved clinical practices and patient outcomes.
- Being tested
- Direct Pulp Capping with ProRoot MTA, Pulpotomy with ProRoot MTA
- Keywords
- Immature Permanent Molars, Pulpotomy, Direct Capping, Root Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Pulp Capping with ProRoot MTAProcedure or surgery
In this intervention, following the removal of carious dentin, the pulp tissue is directly exposed. ProRoot MTA is carefully applied over the exposed pulp to create a protective barrier. The material is mixed according to the manufacturer's instructions and placed directly onto the pulp exposure site. A light pressure is applied to ensure a good adaptation of the material. MTA was covered with resin-modified glass ionomer cement. Restoration was completed using composite resin.
Pulpotomy with ProRoot MTAProcedure or surgery
In this procedure, after the removal of the coronal pulp tissue, ProRoot MTA is applied over the exposed root canal orifices. The MTA is mixed according to the manufacturer's instructions and placed in the pulp chamber to cover the root canal entrances. The material is carefully adapted to create a seal that prevents bacterial contamination and promotes tissue healing. MTA was covered with resin-modified glass ionomer cement. Restoration was completed using composite resin.
| Study group | Role | What they receive |
|---|---|---|
| Direct Capping | Active comparator | The direct capping technique was applied when the pulp exposure was less than 2 mm. In this application, cavity disinfection was achieved with a 2.5% sodium hypochlorite solution due to the exposed pulp. After controlling the bleeding, the MTA was prepared according to the manufacturer's recommendations and placed on the exposed area. The MTA was then covered with resin-modified glass ionomer cement. To ensure proper bonding of the restorative material and a leak-proof restoration, material residues on the cavity walls were removed with a steel round bur. The cavity walls were roughened with 35% orthophosphoric acid. Following the application of a dentin bonding agent, the upper restoration was completed with composite resin using the layering technique. Receives: Procedure: Direct Pulp Capping with ProRoot MTA |
| Pulpotomy | Active comparator | In cases where the pulp exposure was more than 2 mm, the pulpotomy technique was employed. The procedure began with the removal of the pulp roof using steel round burs. The pulp was then amputated up to the pulp canal openings with a sterile sharp spoon excavator. Hemostasis was achieved using a sterile cotton pellet impregnated with physiological saline for 3-5 minutes. If hemostasis could not be achieved and inflammation had progressed to the root pulp, regenerative endodontics was applied. Once hemostasis was secured, the cavity was disinfected again with 2.5% sodium hypochlorite. A 2 mm thick layer of MTA was applied to the pulp base and covered with MTA resin-modified glass ionomer cement. The cavity walls were roughened with 35% orthophosphoric acid after removing material residues with a steel round bur. Following the application of a dentin bonding agent, the upper restoration was completed with composite resin using the layering technique. Receives: Procedure: Pulpotomy with ProRoot MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success after pulpotomy or direct pulp capping treatment
This outcome measure evaluates the absence of pathological signs or symptoms in the treated tooth, including no abscess formation, no swelling, no fistula development, no abnormal mobility, and no post-operative pain. Additionally, the absence of pain on palpation or percussion of the tooth is assessed.
Measured: 6 Month - 1 Year- 18 month
Radiographic assessment after pulpotomy or direct pulp capping treatment
This outcome measure involves the radiographic evaluation of the treated tooth post-pulpotomy or direct pulp capping. The assessment focuses on the absence of root resorption (both internal and external), no furcation involvement, no periapical radiolucency, and no loss of lamina dura. Additionally, a normal appearance of the periodontal ligament space is expected. The natural progression of root formation and root apex closure, known as maturogenesis, will be monitored according to Moorrees classification (stages R½, R¾, Rc, A½, and Ac), ensuring the process follows this sequence.
Measured: 6 Month - 1 Year - 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start5 Jun 2023
- Primary completion13 Dec 2023
- Study completion5 Jun 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 Symptomatic Reversible Pulpitis (Disorder)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Alagöz, Ataturk University
- Investigators
- sera derelioğlu, Prof. dr, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575062
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/360
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alagoz M, Derelioglu SS. The effect of different treatment methods on apical closure and treatment success in immature permanent first molars with reversible pulpitis. BMC Oral Health. 2025 Oct 8;25(1):1556. doi: 10.1186/s12903-025-06975-3.
PubMed 41063117
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Treatment Methods on Apical Closure and Treatment Success in Immature Permanent First Molars With Reversible Pulpitis
- ClinicalTrials.gov ID
- NCT06575062
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/360
- Keywords
- Immature Permanent Molars, Pulpotomy, Direct Capping, Root Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 28 Aug 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 purpose of this thesis study is to evaluate the clinical and radiographic success of direct capping and pulpotomy applications using ProRoot MTA (mineral trioxide aggregate) in lower permanent first molars with reversible pulpitis symptoms that have not yet completed their root development. Additionally, the study aims to assess the effects of these treatments on maturogenesis, specifically root development and apical closure.
Detailed description
The objective of this thesis is to investigate the effectiveness of direct capping and pulpotomy treatments using ProRoot MTA in managing reversible pulpitis in lower permanent first molars that have not yet achieved full root development. This study focuses on assessing both clinical and radiographic outcomes of these dental procedures. Specifically, it aims to determine the impact of these treatments on the natural progression of root formation and the closure of the root apex, a process known as maturogenesis. By examining these factors, the study seeks to provide a comprehensive understanding of how ProRoot MTA can be utilized to facilitate proper root development and healing in immature permanent molars affected by reversible pulpitis.
The study will test the following hypotheses:
Hypothesis 1: There is no difference between the clinical and radiographic success of direct capping and pulpotomy treatments in cases of reversible pulpal involvement of immature permanent molars.
Hypothesis 2: In cases of reversible pulpal involvement of immature permanent molars, direct capping and pulpotomy treatments have no effect on apexogenesis.
Hypothesis 3: Different root development levels of the teeth have no effect on the success of direct capping and pulpotomy treatments in cases of reversible pulpal involvement of immature permanent molars.
The main questions the study aims to answer are:
What are the clinical and radiographic outcomes at 3, 6, 12, and 18 months after treatment with direct capping and pulpotomy using ProRoot MTA.
How do these treatments affect root development and apical closure.
Participants in this study will:
Receive either direct capping or pulpotomy treatments using ProRoot MTA. Undergo clinical and radiographic evaluations at 3, 6, 12, and 18 months post-treatment.
Have their root development stages categorized according to the Moorrees classification (R½, R¾, Rc, A½) to assess the impact of treatments on maturogenesis.
The study aims to provide valuable insights into the effectiveness of ProRoot MTA in treating reversible pulpitis in immature permanent molars, contributing to improved clinical practices and patient outcomes.
Clinical Evaluation Criteria
Presence of spontaneous, long-lasting, or throbbing pain. Sensitivity to percussion and palpation. Presence of a fistula or swelling in the buccal or lingual region. Abnormal tooth mobility.
Radiological Evaluation Criteria
Widening of the periodontal space. Radiolucency in the interradicular or periradicular regions. Evidence of internal or external root resorption. Monitoring of root development stages according to the Moorrees classification. This study aims to provide valuable insights into the effectiveness of ProRoot MTA in treating reversible pulpitis in immature permanent molars, contributing to improved clinical practices and patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Capping | Active comparator | Procedure: Direct Pulp Capping with ProRoot MTAThe direct capping technique was applied when the pulp exposure was less than 2 mm. In this application, cavity disinfection was achieved with a 2.5% sodium hypochlorite solution due to the exposed pulp. After controlling the bleeding, the MTA was prepared according to the manufacturer's recommendations and placed on the exposed area. The MTA was then covered with resin-modified glass ionomer cement. To ensure proper bonding of the restorative material and a leak-proof restoration, material residues on the cavity walls were removed with a steel round bur. The cavity walls were roughened with 35% orthophosphoric acid. Following the application of a dentin bonding agent, the upper restoration was completed with composite resin using the layering technique. |
| Pulpotomy | Active comparator | Procedure: Pulpotomy with ProRoot MTAIn cases where the pulp exposure was more than 2 mm, the pulpotomy technique was employed. The procedure began with the removal of the pulp roof using steel round burs. The pulp was then amputated up to the pulp canal openings with a sterile sharp spoon excavator. Hemostasis was achieved using a sterile cotton pellet impregnated with physiological saline for 3-5 minutes. If hemostasis could not be achieved and inflammation had progressed to the root pulp, regenerative endodontics was applied. Once hemostasis was secured, the cavity was disinfected again with 2.5% sodium hypochlorite. A 2 mm thick layer of MTA was applied to the pulp base and covered with MTA resin-modified glass ionomer cement. The cavity walls were roughened with 35% orthophosphoric acid after removing material residues with a steel round bur. Following the application of a dentin bonding agent, the upper restoration was completed with composite resin using the layering technique. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages ranging from 7 to 10 years.
- Systemically healthy individuals.
- Have symptomatic reversible pulpitis characterized by pain that starts spontaneously and does not subside for a long time but does not include throbbing or night pain.
- Patients with permanent mandibular molars exhibiting open root tips, classified as Moorrees stages R½, R¾, Rc, or A½.
Key exclusion criteria (10 listed)
- Children with systemic diseases.
- Presence of signs indicative of pulp necrosis, such as fistula or swelling in the buccal/lingual region.
- Tenderness upon palpation in the buccal/lingual region.
- Pain upon percussion.
- Presence of interradicular or periradicular radiolucency on radiographic examination.
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 |
|---|---|---|
| Direct Pulp Capping with ProRoot MTAIn this intervention, following the removal of carious dentin, the pulp tissue is directly exposed. ProRoot MTA is carefully applied over the exposed pulp to create a protective barrier. The material is mixed according to the manufacturer's instructions and placed directly onto the pulp exposure site. A light pressure is applied to ensure a good adaptation of the material. MTA was covered with resin-modified glass ionomer cement. Restoration was completed using composite resin. | Procedure or surgery | Direct Capping |
| Pulpotomy with ProRoot MTAIn this procedure, after the removal of the coronal pulp tissue, ProRoot MTA is applied over the exposed root canal orifices. The MTA is mixed according to the manufacturer's instructions and placed in the pulp chamber to cover the root canal entrances. The material is carefully adapted to create a seal that prevents bacterial contamination and promotes tissue healing. MTA was covered with resin-modified glass ionomer cement. Restoration was completed using composite resin. | Procedure or surgery | Pulpotomy |
Primary outcome
Clinical success after pulpotomy or direct pulp capping treatment
Time frame: 6 Month - 1 Year- 18 month
This outcome measure evaluates the absence of pathological signs or symptoms in the treated tooth, including no abscess formation, no swelling, no fistula development, no abnormal mobility, and no post-operative pain. Additionally, the absence of pain on palpation or percussion of the tooth is assessed.
Radiographic assessment after pulpotomy or direct pulp capping treatment
Time frame: 6 Month - 1 Year - 18 month
This outcome measure involves the radiographic evaluation of the treated tooth post-pulpotomy or direct pulp capping. The assessment focuses on the absence of root resorption (both internal and external), no furcation involvement, no periapical radiolucency, and no loss of lamina dura. Additionally, a normal appearance of the periodontal ligament space is expected. The natural progression of root formation and root apex closure, known as maturogenesis, will be monitored according to Moorrees classification (stages R½, R¾, Rc, A½, and Ac), ensuring the process follows this sequence.
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 2 Jul 2025.
- Derived from this study: PubMed 41063117Alagoz M, Derelioglu SS. The effect of different treatment methods on apical closure and treatment success in immature permanent first molars with reversible pulpitis. BMC Oral Health. 2025 Oct 8;25(1):1556. doi: 10.1186/s12903-025-06975-3.
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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.
sera derelioğlu, Prof. dr 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 Direct Pulp Capping with ProRoot MTA and Pulpotomy with ProRoot MTA in people with Symptomatic Reversible Pulpitis (Disorder), 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 4 inclusion and 10 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 2 Jul 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 after pulpotomy or direct pulp capping treatment (time frame: 6 Month - 1 Year- 18 month). 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 NCT06575062, 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 2 Jul 2025.