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| ID | Type | Description | Link |
|---|---|---|---|
| TSA-2021-2486. | Other Grant/Funding Number | Inonu University Scientific Research Projects Unit (BAP) |
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| Name | Class |
|---|---|
| Inonu University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTA Group | Experimental | Primary molars treated with Mineral Trioxide Aggregate (MTA) as the pulpotomy medicament. |
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| Biodentine Group | Experimental | Primary molars treated with Biodentine as the pulpotomy medicament. |
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| Ferric Sulfate Group | Experimental | Primary molars treated with 15.5% Ferric Sulfate as the pulpotomy medicament. |
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| Sodium Hypochlorite Gel Group | Experimental | Primary molars treated with 5% Sodium Hypochlorite gel as the pulpotomy medicament. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mineral Trioxide Aggregate (MTA) | Drug | Used as the capping agent after coronal pulp removal in primary molars. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after pulpotomy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after pulpotomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| sacide duman, Assoc Prof | Inonu University, Faculty of Dentistry, Department of Pediatric Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inonu University, Faculty of Dentistry, Department of Pediatric Dentistry | Malatya | 44280 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41353690 | Derived | 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. |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2025 | Aug 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D011671 | Pulpitis |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D003788 | Dental Pulp Diseases |
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| ID | Term |
|---|---|
| C086631 | mineral trioxide aggregate |
| C000624565 | ProRoot MTA |
| C506393 | tricalcium silicate |
| C024823 | ferric sulfate |
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This is a randomized controlled clinical trial with a split-mouth design where each participant receives multiple interventions on different teeth.
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Outcome assessors are blinded to the treatment allocation to reduce assessment bias. Participants, care providers, and investigators are aware of the assigned treatments.
| Biodentine | Drug | Used as a bioactive pulpotomy agent following coronal pulp amputation. |
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| Ferric Sulfate | Drug | 15.5% Ferric Sulfate applied to pulp stumps for 15 seconds during pulpotomy procedure. |
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| Sodium hypochlorite gel application | Drug | 5% NaOCl gel applied to pulp tissue during pulpotomy for its hemostatic and disinfectant effects. |
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