Dental CariesNCT07120321
Pulpotomy Materials in Primary Molars
A study testing Mineral Trioxide Aggregate (MTA), Biodentine and Ferric Sulfate in people with Dental Caries and Pulpitis, run by Sacide Duman at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial aims to compare four different materials used in a dental procedure called pulpotomy. Pulpotomy is commonly performed on primary molars (back teeth in children) to treat deep cavities and preserve the tooth. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Dental Caries, Pulpitis
- What is being tested?
- Mineral Trioxide Aggregate (MTA), Biodentine and Ferric Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jul 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
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 4 and 7 years
- At least one primary molar indicated for pulpotomy
- No spontaneous pain or systemic infection
- Cooperative behavior according to the Frankl Behavior Rating Scale (scores 3 or 4)
- Signed informed consent from parents or legal guardians
Who cannot join
- Medically compromised children or presence of systemic diseases (e.g., bleeding disorders, immunodeficiency)
- Uncooperative behavior (Frankl rating 1 or 2)
- Primary teeth with signs of pulpal necrosis, abscess, sinus tract, or non-restorable crown
- History of allergy to any materials used in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University, Faculty of Dentistry, Department of Pediatric Dentistry
Malatya, 44280
About this study
Official title: Twelve-Month Prospective Evaluation of Clinical and Radiographic Outcomes of Pulpotomy Materials in Primary Molars
This randomized clinical trial aims to compare four different materials used in a dental procedure called pulpotomy. Pulpotomy is commonly performed on primary molars (back teeth in children) to treat deep cavities and preserve the tooth. Children aged 4 to 7 who need this procedure will receive one of four materials: Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate, or Sodium Hypochlorite gel. The treated teeth will be checked at 6 and 12 months to evaluate the success of each material. The goal is to identify the most effective and reliable material for pulpotomy in primary molars.
Read the detailed description
Vital pulpotomy is a conservative and widely used treatment to maintain the function of primary molars affected by deep carious lesions. The choice of pulpotomy medicament plays a significant role in the long-term success of the procedure.
This randomized clinical trial is designed to compare the clinical and radiographic success rates of four pulpotomy agents: Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate (FS), and Sodium Hypochlorite gel (NaOCl gel).
A total of 88 mandibular second primary molars in children aged 4 to 7 years will be included. After coronal pulp removal, one of the four materials will be applied to the pulp tissue. All treated teeth will be restored with stainless steel crowns. Follow-up evaluations will be performed at 6 and 12 months to assess the clinical and radiographic success of each material.
The findings from this study are expected to help determine the most effective and reliable pulpotomy material for use in pediatric dentistry.
- Conditions
- Dental Caries, Pulpitis
- Being tested
- Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate, Sodium hypochlorite gel application
- Keywords
- Pulpotomy, Primary Molars, Calcium Silicate, Sodium Hypochlorite, Pediatric Dentistry, Vital Pulp Therapy
- Medical subject headings
- Dental Caries, Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral Trioxide Aggregate (MTA)Drug
Also called MTA; ProRoot MTA
Used as the capping agent after coronal pulp removal in primary molars.
BiodentineDrug
Also called Septodont Biodentine; Calcium Silicate Cement
Used as a bioactive pulpotomy agent following coronal pulp amputation.
Ferric SulfateDrug
Also called Astringedent; FS
15.5% Ferric Sulfate applied to pulp stumps for 15 seconds during pulpotomy procedure.
Sodium hypochlorite gel applicationDrug
Also called NaOCl gel; Hypochlorite gel
5% NaOCl gel applied to pulp tissue during pulpotomy for its hemostatic and disinfectant effects.
| Study group | Role | What they receive |
|---|---|---|
| MTA Group | Experimental | Primary molars treated with Mineral Trioxide Aggregate (MTA) as the pulpotomy medicament. Receives: Drug: Mineral Trioxide Aggregate (MTA) |
| Biodentine Group | Experimental | Primary molars treated with Biodentine as the pulpotomy medicament. Receives: Drug: Biodentine |
| Ferric Sulfate Group | Experimental | Primary molars treated with 15.5% Ferric Sulfate as the pulpotomy medicament. Receives: Drug: Ferric Sulfate |
| Sodium Hypochlorite Gel Group | Experimental | Primary molars treated with 5% Sodium Hypochlorite gel as the pulpotomy medicament. Receives: Drug: Sodium hypochlorite gel application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinical success after pulpotomy in primary molars
Clinical success is defined as the absence of spontaneous pain, swelling, sinus tract, or abnormal mobility in the treated tooth during clinical examination.
Measured: 12 months after pulpotomy
Secondary outcomes (1)
Number of participants with radiographic success after pulpotomy in primary molars
Radiographic success is defined as the absence of internal/external root resorption, periapical or furcal radiolucency, and periodontal ligament widening.
Measured: 12 months after pulpotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Jan 2022
- Primary completion1 Jan 2025
- Study completion1 Jul 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 Dental CariesStudies 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
- Crossover
- Model description
- This is a randomized controlled clinical trial with a split-mouth design where each participant receives multiple interventions on different teeth.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sacide Duman
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Sponsor-investigator, Sacide Duman, Inonu University
- Investigators
- sacide duman, Assoc Prof, Principal investigator, Inonu University, Faculty of Dentistry, Department of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120321
- Sponsor's protocol ID
- 2021/77-INUDF
- Other IDs
- TSA-2021-2486.
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data due to privacy concerns and institutional data protection policies. Data may be available upon reasonable request and with appropriate ethical approvals.
Publications
Vural H, Senem Ozsunkar P, Duman S, Syed AZ, Tirasci G. Clinical and radiographic outcomes of four pulpotomy agents in primary molars: a prospective randomized controlled trial. Odontology. 2025 Dec 7. doi: 10.1007/s10266-025-01281-4. Online ahead of print.
PubMed 41353690
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve-Month Prospective Evaluation of Clinical and Radiographic Outcomes of Pulpotomy Materials in Primary Molars
- ClinicalTrials.gov ID
- NCT07120321
- Acronym / sponsor ID
- 2021/77-INUDF
- Conditions
- Dental Caries, Pulpitis
- Keywords
- Pulpotomy, Primary Molars, Calcium Silicate, Sodium Hypochlorite, Pediatric Dentistry, Vital Pulp Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sacide DumanUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 13 Aug 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.
This randomized clinical trial aims to compare four different materials used in a dental procedure called pulpotomy. Pulpotomy is commonly performed on primary molars (back teeth in children) to treat deep cavities and preserve the tooth. Children aged 4 to 7 who need this procedure will receive one of four materials: Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate, or Sodium Hypochlorite gel. The treated teeth will be checked at 6 and 12 months to evaluate the success of each material. The goal is to identify the most effective and reliable material for pulpotomy in primary molars.
Detailed description
Vital pulpotomy is a conservative and widely used treatment to maintain the function of primary molars affected by deep carious lesions. The choice of pulpotomy medicament plays a significant role in the long-term success of the procedure.
This randomized clinical trial is designed to compare the clinical and radiographic success rates of four pulpotomy agents: Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate (FS), and Sodium Hypochlorite gel (NaOCl gel).
A total of 88 mandibular second primary molars in children aged 4 to 7 years will be included. After coronal pulp removal, one of the four materials will be applied to the pulp tissue. All treated teeth will be restored with stainless steel crowns. Follow-up evaluations will be performed at 6 and 12 months to assess the clinical and radiographic success of each material.
The findings from this study are expected to help determine the most effective and reliable pulpotomy material for use in pediatric dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This is a randomized controlled clinical trial with a split-mouth design where each participant receives multiple interventions on different teeth.
| Arm | Type | Receives |
|---|---|---|
| MTA Group | Experimental | Drug: Mineral Trioxide Aggregate (MTA)Primary molars treated with Mineral Trioxide Aggregate (MTA) as the pulpotomy medicament. |
| Biodentine Group | Experimental | Drug: BiodentinePrimary molars treated with Biodentine as the pulpotomy medicament. |
| Ferric Sulfate Group | Experimental | Drug: Ferric SulfatePrimary molars treated with 15.5% Ferric Sulfate as the pulpotomy medicament. |
| Sodium Hypochlorite Gel Group | Experimental | Drug: Sodium hypochlorite gel applicationPrimary molars treated with 5% Sodium Hypochlorite gel as the pulpotomy medicament. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 4 and 7 years
- At least one primary molar indicated for pulpotomy
- No spontaneous pain or systemic infection
- Cooperative behavior according to the Frankl Behavior Rating Scale (scores 3 or 4)
- Signed informed consent from parents or legal guardians
Key exclusion criteria (4 listed)
- Medically compromised children or presence of systemic diseases (e.g., bleeding disorders, immunodeficiency)
- Uncooperative behavior (Frankl rating 1 or 2)
- Primary teeth with signs of pulpal necrosis, abscess, sinus tract, or non-restorable crown
- History of allergy to any materials used in the study
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 |
|---|---|---|
| Mineral Trioxide Aggregate (MTA)Also: MTA; ProRoot MTAUsed as the capping agent after coronal pulp removal in primary molars. | Drug | MTA Group |
| BiodentineAlso: Septodont Biodentine; Calcium Silicate CementUsed as a bioactive pulpotomy agent following coronal pulp amputation. | Drug | Biodentine Group |
| Ferric SulfateAlso: Astringedent; FS15.5% Ferric Sulfate applied to pulp stumps for 15 seconds during pulpotomy procedure. | Drug | Ferric Sulfate Group |
| Sodium hypochlorite gel applicationAlso: NaOCl gel; Hypochlorite gel5% NaOCl gel applied to pulp tissue during pulpotomy for its hemostatic and disinfectant effects. | Drug | Sodium Hypochlorite Gel Group |
Primary outcome
Number of participants with clinical success after pulpotomy in primary molars
Time frame: 12 months after pulpotomy
Clinical success is defined as the absence of spontaneous pain, swelling, sinus tract, or abnormal mobility in the treated tooth during clinical examination.
1 secondary outcome
Number of participants with radiographic success after pulpotomy in primary molars
Time frame: 12 months after 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 Aug 2025.
- Derived from this study: PubMed 41353690Vural H, Senem Ozsunkar P, Duman S, Syed AZ, Tirasci G. Clinical and radiographic outcomes of four pulpotomy agents in primary molars: a prospective randomized controlled trial. Odontology. 2025 Dec 7. doi: 10.1007/s10266-025-01281-4. Online ahead of print.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data due to privacy concerns and institutional data protection policies. Data may be available upon reasonable request and with appropriate ethical approvals.
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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.
sacide duman, Assoc Prof principal investigator
Inonu University, Faculty of Dentistry, Department of Pediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mineral Trioxide Aggregate (MTA), Biodentine and Ferric Sulfate in people with Dental Caries and Pulpitis, run by Sacide Duman 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 4 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 Aug 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?
Number of participants with clinical success after pulpotomy in primary molars (time frame: 12 months after pulpotomy). 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 NCT07120321, 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 13 Aug 2025.