Dental CariesNCT07548008
Ferric Sulfate and Sodium Hypochlorite Pulpotomies in Vital Primary Teeth
An observational study of Dental Caries and Pulpotomies Primary Teeth, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the clinical and radiographic success of two commonly used pulpotomy agents, ferric sulfate (FS) and sodium hypochlorite (NaOCl), in vital primary molars. Pulpotomy is a widely used vital pulp therapy procedure in pediatric dentistry to preserve primary teeth until their natural exfoliation. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Dental Caries, Pulpotomies Primary Teeth
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2025to 10 Feb 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of children aged 4-9 years who were treated at the Department of Pediatric Dentistry, Marmara University Faculty of Dentistry. These participants had previously undergone pulpotomy treatment in vital primary molars using either ferric sulfate or sodium hypochlorite as part of routine clinical care. The study includes patients with available clinical records and diagnostic radiographs, and who are followed during routine recall visits at 6, 12, and 24 months. No additional interventions are performed as part of the study.
Who may be able to join
- Children aged 4-9 years
- Patients who received pulpotomy treatment in vital primary molars using 15.5% ferric sulfate or 5% sodium hypochlorite between January and April 2025 Availability of preoperative diagnostic periapical radiographs of adequate quality
- Complete clinical records of the pulpotomy procedure
- Patients who attended or agreed to attend follow-up visits at 6, 12, and 24 months
- Cases in which the treatment protocol and materials used were clearly documented
Who cannot join
- Incomplete or poor-quality clinical and/or radiographic records
- Presence of systemic diseases (e.g., immunosuppression, uncontrolled systemic conditions)
- History of allergy or hypersensitivity to ferric sulfate or sodium hypochlorite
- Teeth with intraoperative complications (e.g., perforation, uncontrolled bleeding, or change in treatment plan)
- Teeth with pulp exposure due to trauma (only caries-related cases included)
- Patients who did not attend follow-up visits or attended only one follow-up visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical and Radiographic Outcomes of Ferric Sulfate and Sodium Hypochlorite Pulpotomies in Vital Primary Teeth
This study aims to compare the clinical and radiographic success of two commonly used pulpotomy agents, ferric sulfate (FS) and sodium hypochlorite (NaOCl), in vital primary molars. Pulpotomy is a widely used vital pulp therapy procedure in pediatric dentistry to preserve primary teeth until their natural exfoliation.
The study will include children aged 4-9 years who previously received pulpotomy treatment using either FS or NaOCl at Marmara University Faculty of Dentistry. No additional treatment will be performed as part of this study. Patients will be followed during routine clinical visits at 6, 12, and 24 months.
Clinical outcomes such as pain, mobility, and infection, as well as radiographic findings including resorption and radiolucency, will be evaluated. The results of this study are expected to provide evidence for the effectiveness of these materials and support clinical decision-making in pediatric dental practice.
- Conditions
- Dental Caries, Pulpotomies Primary Teeth
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ferric Sulfate Group | Children aged 4-9 years who received pulpotomy treatment in vital primary molars using 15.5% ferric sulfate as part of routine clinical care. | |
| Sodium Hypochlorite Group | Children aged 4-9 years who received pulpotomy treatment in vital primary molars using 5% sodium hypochlorite as part of routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and Radiographic Success Rate of Pulpotomy
The primary outcome is the clinical and radiographic success of pulpotomy-treated primary teeth. Clinical success is defined as the absence of pain, mobility, fistula, abscess, or tenderness to percussion. Radiographic success is defined as the absence of internal or external resorption, periapical or furcal radiolucency, and other pathological findings.
Measured: 24 months
Secondary outcomes (2)
Clinical Success Rate
Evaluation of clinical success based on absence of pain, mobility, fistula, abscess, and tenderness.
Measured: 6, 12, and 24 months
Radiographic Success Rate
Evaluation of radiographic success based on absence of pathological findings such as resorption and radiolucency.
Measured: 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start10 Aug 2025
- Primary completion10 Feb 2027 (estimated)
- Study completion10 Feb 2027 (estimated)
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 Dental CariesStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağla Kondoz, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548008
- Sponsor's protocol ID
- 2025-08
- Other IDs
- Ethics Committee
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. The study involves pediatric participants, and all data are anonymized and handled in accordance with ethical guidelines and data protection regulations.
Publications
Coll JA, Seale NS, Vargas K, Marghalani AA, Al Shamali S, Graham L. Primary Tooth Vital Pulp Therapy: A Systematic Review and Meta-analysis. Pediatr Dent. 2017 Jan 15;39(1):16-123.
PubMed 28292337
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical and Radiographic Outcomes of Ferric Sulfate and Sodium Hypochlorite Pulpotomies in Vital Primary Teeth
- ClinicalTrials.gov ID
- NCT07548008
- Acronym / sponsor ID
- 2025-08
- Conditions
- Dental Caries, Pulpotomies Primary Teeth
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 23 Apr 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 study aims to compare the clinical and radiographic success of two commonly used pulpotomy agents, ferric sulfate (FS) and sodium hypochlorite (NaOCl), in vital primary molars. Pulpotomy is a widely used vital pulp therapy procedure in pediatric dentistry to preserve primary teeth until their natural exfoliation.
The study will include children aged 4-9 years who previously received pulpotomy treatment using either FS or NaOCl at Marmara University Faculty of Dentistry. No additional treatment will be performed as part of this study. Patients will be followed during routine clinical visits at 6, 12, and 24 months.
Clinical outcomes such as pain, mobility, and infection, as well as radiographic findings including resorption and radiolucency, will be evaluated. The results of this study are expected to provide evidence for the effectiveness of these materials and support clinical decision-making in pediatric dental practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric Sulfate Group | – | –Children aged 4-9 years who received pulpotomy treatment in vital primary molars using 15.5% ferric sulfate as part of routine clinical care. |
| Sodium Hypochlorite Group | – | –Children aged 4-9 years who received pulpotomy treatment in vital primary molars using 5% sodium hypochlorite as part of routine clinical care. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of children aged 4-9 years who were treated at the Department of Pediatric Dentistry, Marmara University Faculty of Dentistry. These participants had previously undergone pulpotomy treatment in vital primary molars using either ferric sulfate or sodium hypochlorite as part of routine clinical care. The study includes patients with available clinical records and diagnostic radiographs, and who are followed during routine recall visits at 6, 12, and 24 months. No additional interventions are performed as part of the study.
Key inclusion criteria (5 listed)
- Children aged 4-9 years
- Patients who received pulpotomy treatment in vital primary molars using 15.5% ferric sulfate or 5% sodium hypochlorite between January and April 2025 Availability of preoperative diagnostic periapical radiographs of adequate quality
- Complete clinical records of the pulpotomy procedure
- Patients who attended or agreed to attend follow-up visits at 6, 12, and 24 months
- Cases in which the treatment protocol and materials used were clearly documented
Key exclusion criteria (6 listed)
- Incomplete or poor-quality clinical and/or radiographic records
- Presence of systemic diseases (e.g., immunosuppression, uncontrolled systemic conditions)
- History of allergy or hypersensitivity to ferric sulfate or sodium hypochlorite
- Teeth with intraoperative complications (e.g., perforation, uncontrolled bleeding, or change in treatment plan)
- Teeth with pulp exposure due to trauma (only caries-related cases included)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical and Radiographic Success Rate of Pulpotomy
Time frame: 24 months
The primary outcome is the clinical and radiographic success of pulpotomy-treated primary teeth. Clinical success is defined as the absence of pain, mobility, fistula, abscess, or tenderness to percussion. Radiographic success is defined as the absence of internal or external resorption, periapical or furcal radiolucency, and other pathological findings.
2 secondary outcomes
Clinical Success Rate
Time frame: 6, 12, and 24 months
Radiographic Success Rate
Time frame: 6, 12, and 24 months
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 23 Apr 2026.
- Background: PubMed 28292337Coll JA, Seale NS, Vargas K, Marghalani AA, Al Shamali S, Graham L. Primary Tooth Vital Pulp Therapy: A Systematic Review and Meta-analysis. Pediatr Dent. 2017 Jan 15;39(1):16-123.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. The study involves pediatric participants, and all data are anonymized and handled in accordance with ethical guidelines and data protection regulations.
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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?
An observational study of Dental Caries and Pulpotomies Primary Teeth, run by Marmara 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 5 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 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?
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 and Radiographic Success Rate of Pulpotomy (time frame: 24 months). 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 NCT07548008, 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 23 Apr 2026.