NCT07864181|CompletedPhase 1/2
TheraCal PT vs. Formocresol in Primary Molar Pulpotomies
TheraCal PT Versus Formocresol in Primary Molar Pulpotomies: Clinical and Radiographic Outcomes at 12 Months Follow-Up
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TheraCal PT Versus Formocresol in Primary Molar Pulpotomies: Clinical and Radiographic Outcomes at 12 Months Follow-Up
Sponsor study identifier
interventional
50
1 country
1
Study Start
January 1, 2024
Actual (reported)Primary Completion
June 3, 2025
Actual (reported)Study Completion
December 23, 2025
Actual (reported)This prospective, randomized, parallel-group clinical trial evaluated the 12-month clinical and radiographic success rates of TheraCal PT versus formocresol in primary molar vital pulpotomies among 50 children aged 5 to 8 years. At the conclusion of the follow-up period, both materials demonstrated a 100% clinical success rate, while radiographic success rates were 92% for the formocresol group and 80% for the TheraCal PT group, showing no statistically significant differences between the two treatments.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 23, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2024
Actual (reported)June 3, 2025
Actual (reported)December 23, 2025
Actual (reported)September 27, 2026
Actual (reported)October 7, 2026
Actual (reported)Percentage of Primary Molars Demonstrating Clinical Success
Total absence of subjective or objective clinical signs and symptoms of pulpal or periodontal pathology. This includes the absolute absence of spontaneous or nocturnal pain, tenderness to percussion, localized swelling, fistulous/sinus tracts, or abnormal physiological tooth mobility. The presence of any single clinical sign or symptom is defined as clinical failure.
12 months
Percentage of Primary Molars Demonstrating Radiographic Success
12 months
Total absence of subjective or objective clinical signs and symptoms of pulpal or periodontal pathology. This includes the absolute absence of spontaneous or nocturnal pain, tenderness to percussion, localized swelling, fistulous/sinus tracts, or abnormal physiological tooth mobility. The presence of any single clinical sign or symptom is defined as clinical failure.
Total absence of pulpal and periradicular radiographic pathology, explicitly evaluated via standardized periapical radiographs using the paralleling technique. Success is characterized by the absence of new or progressive periapical radiolucency, inter-radicular furcation radiolucency, or pathological internal or external root resorption. The appearance of any single radiographic lesion is defined as radiographic failure.
Total absence of pulpal and periradicular radiographic pathology, explicitly evaluated via standardized periapical radiographs using the paralleling technique. Success is characterized by the absence of new or progressive periapical radiolucency, inter-radicular furcation radiolucency, or pathological internal or external root resorption. The appearance of any single radiographic lesion is defined as radiographic failure.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hama University
Hama, Syria
Sahin N, Saygili S, Akcay M. Clinical, radiographic, and histological evaluation of three different pulp-capping materials in indirect pulp treatment of primary teeth: a randomized clinical trial. Clin Oral Investig. 2021 Jun;25(6):3945-3955. doi: 10.1007/s00784-020-03724-4. Epub 2021 Jan 6.
Amrollahi N, Karimi R, Shariati F. Clinical and radiographic success of TheraCal versus Formocresol in primary teeth pulpotomy: A systematic review and meta-analysis. Saudi Dent J. 2024 Aug;36(8):1058-1065. doi: 10.1016/j.sdentj.2024.06.008. Epub 2024 Jun 6.
fadi jnaid
Hama University
fadi jnaid
Fadi Jnaid@hama-univ.edu.sy
50 participants (actual enrollment reported by the registry).
First Submitted
September 27, 2026
First Posted
October 7, 2026
Study Start
January 1, 2024
Actual (reported)Effectiveness of Biodentine v/s Calcium Hydroxide as Indirect Pulp Capping Materials
Contact the study team to confirm eligibility.
Baranwal HC, Mittal N, Samad S, Ayubi A, Aggarwal H, Kharat SM. Comparative evaluation of dual-cure resin (TheraCal PT) and Biodentine in coronal pulpotomy of patients with symptoms indicative of irreversible pulpitis: A randomized clinical trial. J Conserv Dent Endod. 2024 Aug;27(8):822-827. doi: 10.4103/JCDE.JCDE_280_24. Epub 2024 Aug 7.
Bakhtiar H, Nekoofar MH, Aminishakib P, Abedi F, Naghi Moosavi F, Esnaashari E, Azizi A, Esmailian S, Ellini MR, Mesgarzadeh V, Sezavar M, About I. Human Pulp Responses to Partial Pulpotomy Treatment with TheraCal as Compared with Biodentine and ProRoot MTA: A Clinical Trial. J Endod. 2017 Nov;43(11):1786-1791. doi: 10.1016/j.joen.2017.06.025. Epub 2017 Aug 16.
Hassanpour S, Aminabadi NA, Rahbar M, Erfanparast L. Comparison between the Radiographic and Clinical Rates of Success for TheraCal and MTA in Primary Tooth Pulpotomy within a 12-Month Follow-Up: A Split-Mouth Clinical Trial. Biomed Res Int. 2023 Apr 19;2023:8735145. doi: 10.1155/2023/8735145. eCollection 2023.
Primary Completion
June 3, 2025
Actual (reported)Study Completion
December 23, 2025
Actual (reported)Last Updated
October 7, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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