Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
22 participants
INTERVENTIONAL
2022-01-01
2025-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of The Success Rates of Four Different Pulpotomy Techniques
NCT03135626
Comparison Of Clinical And Radiological Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeth
NCT07260357
Clinical and Radiographic Evaluation of Propolis As a Hemostatic Agent for Pulpotomy of Mature Permanent Molars with Irreversible Pulpitis Using Two Different Dressing Materials
NCT06679075
MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial
NCT02019563
Partial Versus Complete Pulpotomy Using Three Different Materials in Primary Molars: a Clinical Study
NCT05190783
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MTA Group
Primary molars treated with Mineral Trioxide Aggregate (MTA) as the pulpotomy medicament.
Mineral Trioxide Aggregate (MTA)
Used as the capping agent after coronal pulp removal in primary molars.
Biodentine Group
Primary molars treated with Biodentine as the pulpotomy medicament.
Biodentine
Used as a bioactive pulpotomy agent following coronal pulp amputation.
Ferric Sulfate Group
Primary molars treated with 15.5% Ferric Sulfate as the pulpotomy medicament.
Ferric Sulfate
15.5% Ferric Sulfate applied to pulp stumps for 15 seconds during pulpotomy procedure.
Sodium Hypochlorite Gel Group
Primary molars treated with 5% Sodium Hypochlorite gel as the pulpotomy medicament.
Sodium hypochlorite gel application
5% NaOCl gel applied to pulp tissue during pulpotomy for its hemostatic and disinfectant effects.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mineral Trioxide Aggregate (MTA)
Used as the capping agent after coronal pulp removal in primary molars.
Biodentine
Used as a bioactive pulpotomy agent following coronal pulp amputation.
Ferric Sulfate
15.5% Ferric Sulfate applied to pulp stumps for 15 seconds during pulpotomy procedure.
Sodium hypochlorite gel application
5% NaOCl gel applied to pulp tissue during pulpotomy for its hemostatic and disinfectant effects.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
4 Years
7 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Inonu University
OTHER
Sacide Duman
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sacide Duman
Assoc. Prof. Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
sacide duman, Assoc Prof
Role: PRINCIPAL_INVESTIGATOR
Inonu University, Faculty of Dentistry, Department of Pediatric Dentistry
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Inonu University, Faculty of Dentistry, Department of Pediatric Dentistry
Malatya, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TSA-2021-2486.
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2021/77-INUDF
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.