Reversible PulpitisNCT06874088
Clinical and Radiographic Outcomes of Pulpotomy in Teeth with Different Symptoms and Root Stages
A study testing Pulpotomy with Calcium Silicate-Based Bioceramics in Permanent Teeth in people with Reversible Pulpitis and Irreversible Pulpitis, run by Muhammed Alagöz at 1 site in Turkey (Türkiye).
Trial summary
Pulpotomy is a vital pulp therapy (VPT) method used to maintain pulp vitality by removing inflamed or infected coronal pulp tissue while preserving the health and function of radicular pulp. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversible Pulpitis, Irreversible Pulpitis, Mature Teeth
- What is being tested?
- Pulpotomy with Calcium Silicate-Based Bioceramics in Permanent Teeth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2022to 3 Mar 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mature and immature permanent teeth exposed to caries.
- Teeth with reversible or irreversible clinical symptoms.
- Periapical index (PAI) scores of 1 or 2 (indicating healthy or mildly inflamed periapical tissues) at baseline.
- Patients without any systemic disorders.
Who cannot join
- Radiographic evidence of periradicular or interradicular lesions.
- Presence of internal or external root resorption.
- Patients with systemic conditions that may compromise healing, such as diabetes or immunosuppression.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Dentistry
Erzurum, 25200
About this study
Official title: Evaluation of Clinical and Radiographic Prognosis of Pulpotomy Treatment Performed on Teeth with Different Symptoms and Stages of Root Development: a Retrospective Study
Pulpotomy is a vital pulp therapy (VPT) method used to maintain pulp vitality by removing inflamed or infected coronal pulp tissue while preserving the health and function of radicular pulp. This procedure supports root development in young permanent teeth and helps prevent long-term complications associated with apexogenesis.
Recent studies indicate that pulpotomy can achieve success rates exceeding 90%, even in cases of symptomatic irreversible pulpitis, challenging traditional contraindications. Notably, this high success rate has been observed in both immature and mature permanent teeth, expanding the applicability of pulpotomy across different developmental stages.
Modern materials such as Mineral Trioxide Aggregate (MTA) and Biodentine™ have been widely adopted in regenerative dentistry due to their biocompatibility and superior sealing properties. These materials are used effectively in both immature and mature teeth, contributing to the long-term success of vital pulp therapy.
Read the detailed description
This retrospective study evaluates the effectiveness of bioceramic materials such as Mineral Trioxide Aggregate (MTA) and Biodentine™ in the treatment of both reversible and irreversible pulpitis cases. The study compares the clinical survival rates of pulpotomy in teeth with mature and immature root structures and assesses long-term biological outcomes, including pulp healing, dentin bridge formation, and periapical healing. Additionally, the study aims to address gaps in the literature by providing retrospective data from our country and making it comparable with international standards.
Detailed Description
Study Objectives
To retrospectively analyze the effectiveness of bioceramic materials such as MTA and Biodentine™ in cases of reversible and irreversible pulpitis.
To compare the clinical survival rates of pulpotomy in teeth with mature and immature root structures.
To evaluate long-term biological outcomes based on criteria such as pulp healing, dentin bridge formation, and periapical healing.
To provide retrospective data from our country that can be compared with international standards, addressing gaps in the existing literature.
Clinical Procedure
The treatment protocol was performed by a single pediatric dentist. After local anesthesia, rubber dam isolation was applied to enhance visibility and maintain asepsis. The enamel, dentin, and pulp chamber roof were sequentially removed using ISO 021-023 diamond and steel round burs (NTI-Kahla GmbH, Kahla, Germany). The coronal pulp tissue was amputated up to the root canal orifices using a sterile sharp steel round bur. Hemostasis was achieved by applying a sterile cotton pellet soaked in 2.5% sodium hypochlorite and saline solution.
Following hemostasis, the bioceramic materials were freshly mixed according to the manufacturer's recommendations. A 2-3 mm thick layer of either MTA (Biofactor, Imicryl Dental, Konya, Turkey) or Biodentine™ (Septodont, France) was carefully applied to the pulp chamber floor. The material was then covered with a resin-modified glass ionomer cement (Ionoseal, VOCO GmbH, Cuxhaven, Germany). Any excess material adhering to the cavity walls was removed using a steel round bur to ensure optimal adhesion of the restorative material and to prevent microleakage. The cavity walls were then etched with 35% orthophosphoric acid (Vococid, Voco, Germany), followed by the application of a dentin bonding agent (Futurabond-U, Voco, Germany). The final restoration was completed using a composite resin (Solare-X, GC, Tokyo, Japan) in a layering technique. Occlusal adjustments and polishing were performed in the same session.
Follow-up and Outcome Evaluation
Clinical and radiographic follow-up evaluations were conducted at an average of 24 months post-treatment. Clinical parameters such as spontaneous pain, nocturnal pain, vestibular swelling, pathological mobility, and percussion or palpation sensitivity were recorded before and after treatment to assess success.
Radiographic evaluations were performed using the Periapical Index (PAI) to assess periapical healing, and the presence of a dentin bridge was also examined in follow-up radiographs. Additionally, root development was assessed using the Moorrees Index in initial and follow-up radiographs.
This study provides valuable insight into the long-term effectiveness of pulpotomy in mature and immature teeth, contributing to the existing body of knowledge on vital pulp therapy.
- Being tested
- Pulpotomy with Calcium Silicate-Based Bioceramics in Permanent Teeth
- Keywords
- Vital pulp therapy, Pulpotomy, Dentin bridge formation, Periapical Index, Retrospective study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpotomy with Calcium Silicate-Based Bioceramics in Permanent TeethProcedure or surgery
This intervention involves performing pulpotomy using calcium silicate-based bioceramic materials, MTA and Biodentine™, in both mature and immature permanent teeth diagnosed with reversible or irreversible pulpitis. The study uniquely evaluates the long-term clinical and radiographic success of these materials by assessing pulp healing, dentin bridge formation, and periapical healing over a 24-month follow-up period. Additionally, this study compares clinical survival rates between mature and immature teeth, contributing to the growing body of evidence on the efficacy of pulpotomy in cases traditionally considered for root canal treatment. Unlike conventional pulpotomy studies, this research incorporates retrospective data analysis to align with international standards, addressing gaps in existing literature.
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Experimental | In cases where pulp exposure exceeded 2 mm, the pulpotomy procedure was performed. The intervention commenced with the excision of the pulp chamber roof using a steel round bur. The coronal pulp tissue was then amputated at the level of the canal orifices utilizing a sterile sharp spoon excavator. Hemostasis was achieved by applying a sterile cotton pellet moistened with physiological saline for 3-5 minutes. Once hemostasis was confirmed, the cavity was further disinfected with 2.5% sodium hypochlorite. Subsequently, a 2 mm thick layer of mineral trioxide aggregate was placed over the pulp stump and covered with a resin-modified glass ionomer cement. To enhance adhesion, the cavity walls were conditioned with 35% orthophosphoric acid following the removal of residual material using a steel round bur. After the application of a dentin bonding agent, the definitive restoration was completed with composite resin using an incremental layering technique. Receives: Procedure: Pulpotomy with Calcium Silicate-Based Bioceramics in Permanent Teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success of Pulpotomy in Mature and Immature Permanent Teeth
Clinical success was determined based on the absence of symptoms such as spontaneous pain, tenderness to percussion, swelling, sinus tract formation, and abnormal mobility. Teeth exhibiting normal function without signs of pulpal or periapical pathology during follow-up examinations were classified as clinically successful. Additionally, patient-reported outcomes, including the resolution of preoperative symptoms and continued functionality, were considered in the clinical assessment.
Measured: 24 months
Radiographic Success of Pulpotomy in Mature and Immature Permanent Teeth
Radiographic success was defined by the absence of periapical radiolucency, internal or external root resorption, and signs of pathological changes in the periradicular tissues. Teeth demonstrating a well-preserved root structure, maintained pulp space dimensions, and no evidence of progressive pathology on follow-up radiographs were considered radiographically successful. Consistent findings across multiple follow-up intervals further confirmed the stability of pulpal and periapical health post-pulpotomy.
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 posted13 Mar 2025
- Study start25 May 2022
- Primary completion30 Jan 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversible PulpitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammed Alagöz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammed Alagöz, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874088
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/13
- Other IDs
- atatürk üniversitesi
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Radiographic Prognosis of Pulpotomy Treatment Performed on Teeth with Different Symptoms and Stages of Root Development: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06874088
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/13
- Keywords
- Vital pulp therapy, Pulpotomy, Dentin bridge formation, Periapical Index, Retrospective study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Muhammed AlagözUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 13 Mar 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.
Pulpotomy is a vital pulp therapy (VPT) method used to maintain pulp vitality by removing inflamed or infected coronal pulp tissue while preserving the health and function of radicular pulp. This procedure supports root development in young permanent teeth and helps prevent long-term complications associated with apexogenesis.
Recent studies indicate that pulpotomy can achieve success rates exceeding 90%, even in cases of symptomatic irreversible pulpitis, challenging traditional contraindications. Notably, this high success rate has been observed in both immature and mature permanent teeth, expanding the applicability of pulpotomy across different developmental stages.
Modern materials such as Mineral Trioxide Aggregate (MTA) and Biodentine™ have been widely adopted in regenerative dentistry due to their biocompatibility and superior sealing properties. These materials are used effectively in both immature and mature teeth, contributing to the long-term success of vital pulp therapy.
Detailed description
This retrospective study evaluates the effectiveness of bioceramic materials such as Mineral Trioxide Aggregate (MTA) and Biodentine™ in the treatment of both reversible and irreversible pulpitis cases. The study compares the clinical survival rates of pulpotomy in teeth with mature and immature root structures and assesses long-term biological outcomes, including pulp healing, dentin bridge formation, and periapical healing. Additionally, the study aims to address gaps in the literature by providing retrospective data from our country and making it comparable with international standards.
Detailed Description
Study Objectives
To retrospectively analyze the effectiveness of bioceramic materials such as MTA and Biodentine™ in cases of reversible and irreversible pulpitis.
To compare the clinical survival rates of pulpotomy in teeth with mature and immature root structures.
To evaluate long-term biological outcomes based on criteria such as pulp healing, dentin bridge formation, and periapical healing.
To provide retrospective data from our country that can be compared with international standards, addressing gaps in the existing literature.
Clinical Procedure
The treatment protocol was performed by a single pediatric dentist. After local anesthesia, rubber dam isolation was applied to enhance visibility and maintain asepsis. The enamel, dentin, and pulp chamber roof were sequentially removed using ISO 021-023 diamond and steel round burs (NTI-Kahla GmbH, Kahla, Germany). The coronal pulp tissue was amputated up to the root canal orifices using a sterile sharp steel round bur. Hemostasis was achieved by applying a sterile cotton pellet soaked in 2.5% sodium hypochlorite and saline solution.
Following hemostasis, the bioceramic materials were freshly mixed according to the manufacturer's recommendations. A 2-3 mm thick layer of either MTA (Biofactor, Imicryl Dental, Konya, Turkey) or Biodentine™ (Septodont, France) was carefully applied to the pulp chamber floor. The material was then covered with a resin-modified glass ionomer cement (Ionoseal, VOCO GmbH, Cuxhaven, Germany). Any excess material adhering to the cavity walls was removed using a steel round bur to ensure optimal adhesion of the restorative material and to prevent microleakage. The cavity walls were then etched with 35% orthophosphoric acid (Vococid, Voco, Germany), followed by the application of a dentin bonding agent (Futurabond-U, Voco, Germany). The final restoration was completed using a composite resin (Solare-X, GC, Tokyo, Japan) in a layering technique. Occlusal adjustments and polishing were performed in the same session.
Follow-up and Outcome Evaluation
Clinical and radiographic follow-up evaluations were conducted at an average of 24 months post-treatment. Clinical parameters such as spontaneous pain, nocturnal pain, vestibular swelling, pathological mobility, and percussion or palpation sensitivity were recorded before and after treatment to assess success.
Radiographic evaluations were performed using the Periapical Index (PAI) to assess periapical healing, and the presence of a dentin bridge was also examined in follow-up radiographs. Additionally, root development was assessed using the Moorrees Index in initial and follow-up radiographs.
This study provides valuable insight into the long-term effectiveness of pulpotomy in mature and immature teeth, contributing to the existing body of knowledge on vital pulp therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Experimental | Procedure: Pulpotomy with Calcium Silicate-Based Bioceramics in Permanent TeethIn cases where pulp exposure exceeded 2 mm, the pulpotomy procedure was performed. The intervention commenced with the excision of the pulp chamber roof using a steel round bur. The coronal pulp tissue was then amputated at the level of the canal orifices utilizing a sterile sharp spoon excavator. Hemostasis was achieved by applying a sterile cotton pellet moistened with physiological saline for 3-5 minutes. Once hemostasis was confirmed, the cavity was further disinfected with 2.5% sodium hypochlorite. Subsequently, a 2 mm thick layer of mineral trioxide aggregate was placed over the pulp stump and covered with a resin-modified glass ionomer cement. To enhance adhesion, the cavity walls were conditioned with 35% orthophosphoric acid following the removal of residual material using a steel round bur. After the application of a dentin bonding agent, the definitive restoration was completed with composite resin using an incremental layering technique. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Mature and immature permanent teeth exposed to caries.
- Teeth with reversible or irreversible clinical symptoms.
- Periapical index (PAI) scores of 1 or 2 (indicating healthy or mildly inflamed periapical tissues) at baseline.
- Patients without any systemic disorders.
Key exclusion criteria (3 listed)
- Radiographic evidence of periradicular or interradicular lesions.
- Presence of internal or external root resorption.
- Patients with systemic conditions that may compromise healing, such as diabetes or immunosuppression.
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 |
|---|---|---|
| Pulpotomy with Calcium Silicate-Based Bioceramics in Permanent TeethThis intervention involves performing pulpotomy using calcium silicate-based bioceramic materials, MTA and Biodentine™, in both mature and immature permanent teeth diagnosed with reversible or irreversible pulpitis. The study uniquely evaluates the long-term clinical and radiographic success of these materials by assessing pulp healing, dentin bridge formation, and periapical healing over a 24-month follow-up period. Additionally, this study compares clinical survival rates between mature and immature teeth, contributing to the growing body of evidence on the efficacy of pulpotomy in cases traditionally considered for root canal treatment. Unlike conventional pulpotomy studies, this research incorporates retrospective data analysis to align with international standards, addressing gaps in existing literature. | Procedure or surgery | Pulpotomy |
Primary outcome
Clinical Success of Pulpotomy in Mature and Immature Permanent Teeth
Time frame: 24 months
Clinical success was determined based on the absence of symptoms such as spontaneous pain, tenderness to percussion, swelling, sinus tract formation, and abnormal mobility. Teeth exhibiting normal function without signs of pulpal or periapical pathology during follow-up examinations were classified as clinically successful. Additionally, patient-reported outcomes, including the resolution of preoperative symptoms and continued functionality, were considered in the clinical assessment.
Radiographic Success of Pulpotomy in Mature and Immature Permanent Teeth
Time frame: 24 months
Radiographic success was defined by the absence of periapical radiolucency, internal or external root resorption, and signs of pathological changes in the periradicular tissues. Teeth demonstrating a well-preserved root structure, maintained pulp space dimensions, and no evidence of progressive pathology on follow-up radiographs were considered radiographically successful. Consistent findings across multiple follow-up intervals further confirmed the stability of pulpal and periapical health post-pulpotomy.
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 13 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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 with Calcium Silicate-Based Bioceramics in Permanent Teeth in people with Reversible Pulpitis and Irreversible Pulpitis, run by Muhammed Alagöz 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 3 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 13 Mar 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 of Pulpotomy in Mature and Immature Permanent Teeth (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?
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 13 Mar 2025.