Comparison of Hyaluronic Acid, TheraCal, and Mineral Trioxide Aggregate as Pulpotomy Agents in Primary Molars
NCT ID: NCT07168811
Last Updated: 2025-09-11
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.
NOT_YET_RECRUITING
NA
66 participants
INTERVENTIONAL
2025-10-01
2026-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main question it aims to answer is:
In children with restorable mandibular second primary molars requiring pulpotomy, does the use of hyaluronic acid or TheraCal LC, compared to MTA, result in improved clinical and radiographic success rates over a 12-month follow-up period?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars
NCT06611631
Conservative Pulp Therapy of Primary Molars Using TheraCAL
NCT04167943
Pulp Capping in Primary Molars Using TheraCal (LC)
NCT05167123
Clinical and Radiographic Evaluation of Indirect Pulp Capping in Primary and Permanent Teeth With Different Materials
NCT03606681
Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars
NCT03119779
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
According to MTA research, it has a high success rate as a pulpotomy agent and favors tissue regeneration while also having a good long-term prognosis, good biocompatibility, and strong sealing capacity . Among its many applications are direct pulp capping, pulpotomy, root end filling, apexification, apexogenesis, and root perforation . Low compressive strength, high pH (approximately 10.2 after setting which take 3 hours, pH increase to 12,5), high cost, short shelf life, manipulation challenges, lengthy setting time, and discoloration are some disadvantages.
TheraCal LC (Bisco, Schaumburg, IL, USA) is a novel calcium silicate-based resin-modified material designed as a liner under restorative materials to protect and stimulate the pulp in both direct and indirect pulp capping. It contains polyethylene-glycol dimethacrylate monomers, barium zirconate, and tri-calcium silicate particles. According to earlier research, the TheraCal LC material stimulated the production of secondary dentin and apatite by releasing calcium.
TheraCal provides a number of advantages over other silicate-based materials, including low solubility, easy application, good mechanical properties, setting time, adequate bonding ability, and prevention of microleakage. Commercially available as a syringe, TheraCal is user-friendly. TheraCal is a good option for kids who can't handle long visits and might eventually stop cooperating because of all these benefits.
Hyaluronic Acid (HA) is made up of polyanionic disaccharide units of N-acetyl glucosamine and glucuronic acid joined by alternating β-(1ــــ3) and β-(1ــــ4) linkages. It is a naturally occurring non-sulfated glycosaminoglycan with a high molecular weight of 4000-20,000,000 Da. It is a linear polysaccharide found in the extracellular matrix of skin, vitreous humor, embryonic mesenchyme, connective tissue, synovial fluid, and several other human tissues and organs . It is an appealing material for use in several dental operations due to its biocompatibility, regenerative qualities, and antibacterial properties .
It is used in dentistry to treat alveolar osteitis, peri-implantitis, chronic periodontitis, and gingivitis; manage wound healing following free gingival graft; control symptoms like pain, swelling, and trismus that may arise following tooth extraction; heal recurrent oral ulcers; and to manage teething symptoms. Additionally, HA is employed in research utilizing human dental pulp stem cells (hDPSCs) in an effort to offer a novel method of regenerative endodontic therapy.
So the present study will be conducted for evaluation of Hyaluronic Acid, TheraCal, and Mineral Trioxide Aggregate as Pulpotomy Agents in Primary Molars.
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
PARALLEL
2. Group II: theraCal LC. (Study group).
3. Group III: MTA (Control group).
TREATMENT
TRIPLE
Patient and Parent Blinding: Participants and their parents/legal guardians will be blinded to the type of pulpotomy agent used. All materials will be applied under rubber dam isolation, and the clinical procedure will be standardized to avoid revealing the material identity.
Outcome Assessor Blinding: The clinical and radiographic evaluations will be performed by a blinded, calibrated examiner who is unaware of the group assignments. The radiographs will be coded and assessed using standardized criteria to prevent bias.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hyaluronic acid
• After achieving complete hemostasis: Mix HA (0,5% gengigel teething) with ZO powder until a mixture, then apply it on pulp stumps.
all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India).
Hyaluronic Acid (HA)
• After achieving complete hemostasis:
1. Mix HA (0,5% gengigel teething) with ZO powder until a mixture, then apply it on pulp stumps.
2. all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India)
TheraCal
• After achieving complete hemostasis: TheraCal L.C will be applied directly to the radicular pulp by a disposable syringe tip and light cure will be done for 20 seconds.
all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India).
TheraCal
• After achieving complete hemostasis:
1. TheraCal L.C will be applied directly to the radicular pulp by a disposable syringe tip and light cure will be done for 20 seconds.
2. all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India)
Mineral Trioxide Aggregate
• After achieving complete hemostasis: mix MTA with sterile saline and put on pulp stumps. A moist cotton pellet was placed for initial setting.
all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India).
Mineral Trioxide Aggregate
• After achieving complete hemostasis:
1. mix MTA with sterile saline and put on pulp stumps. A moist cotton pellet was placed for initial setting.
2. all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hyaluronic Acid (HA)
• After achieving complete hemostasis:
1. Mix HA (0,5% gengigel teething) with ZO powder until a mixture, then apply it on pulp stumps.
2. all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India)
TheraCal
• After achieving complete hemostasis:
1. TheraCal L.C will be applied directly to the radicular pulp by a disposable syringe tip and light cure will be done for 20 seconds.
2. all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India)
Mineral Trioxide Aggregate
• After achieving complete hemostasis:
1. mix MTA with sterile saline and put on pulp stumps. A moist cotton pellet was placed for initial setting.
2. all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India)
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
* Co-operative patient
* At least one restorable mandibular second primary molars with deep carious lesions requiring pulpotomy.
* Absence of gingival swelling or sinus tract.
* Absence of spontaneous pain.
* Absence of pain on percussion.
* Controlled bleeding.
* First treatment the tooth.
* Possibility of restoring the tooth with a stainless steel crown.
* No Radiographic evidence of changes associated with pulp degeneration, such as widening of PDL space, internal root resorption, external root resorption, inter-radicular or periapical bone destruction (radiolucency).
Exclusion Criteria
* Spontaneous pain.
* Necrotic pulp, pathological mobility.
* Cases require for general anesthesia.
* A history of repeated need for analgesics.
* Patients with any systemic diseases.
* Uncontrolled bleeding.
* Selected deciduous teeth without a permanent successor
4 Years
8 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Al-Azhar University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Omaima Salah Ahmed Mohamed Elbeltagy
Doctor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Al-Azhar University
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Dr. Adel Fathy Hussein, Professor
Role: CONTACT
References
Explore related publications, articles, or registry entries linked to this study.
Cameron, Angus C., and Richard P. Widmer, eds. Handbook of Pediatric Dentistry E-Book: Handbook of Pediatric Dentistry E-Book. 5th ed. Elsevier Health Sciences, 2021. P. 131.
Khatab, Arafa, and Elsayed Mohamed Deraz. "Clinical, radiographical and histopathological evaluation of Biodentine versus formocresol in primary teeth pulpotomy." Egyptian Dental Journal 65.4-October (Orthodontics, Pediatric & Preventive Dentistry) (2019): 3199-3212
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.
Jha S, Namdev R, Singhal R, Goel N, Singhal P, Rani R. Comparative Evaluation of Effectiveness of TheraCal LC, MTA, and Calcium Hydroxide in Direct Pulp Capping in Primary Molars: Randomized Clinical Study. Int J Clin Pediatr Dent. 2023 Sep;16(Suppl 2):213-219. doi: 10.5005/jp-journals-10005-2642.
Ildes GC, Sezgin BI, Vieira AR, Mentes A. A randomized clinical trial of hyaluronic acid gel pulpotomy in primary molars with 1 year follow-up. Acta Odontol Scand. 2022 May;80(4):273-280. doi: 10.1080/00016357.2021.1998612. Epub 2021 Nov 9.
Shaimaa mohamed Mahfouz; asmaa abdallah; shaimaa shaban el-desouky. "Clinical and Radiographic Evaluation of Hyaluronic Acid as a Vital Pulpotomy Medication in Primary Molars", Egyptian Dental Journal, 67, 3, 2021, 1843-1855
Verma, Bhawna, et al. "Comparative evaluation of success of pulpotomy in primary molars treated with Formocresol, Pulpotec and Biodentine-6 month follow up study." Int J Appl Dent Sci 5 (2019): 77-82.
Sezgin BI, Ildes Sezgin GC, Koyuncu O, Mentes A. Hyaluronic acid as a pulpotomy material in primary molars: an up to 30 months retrospective study. BMC Oral Health. 2024 Jun 12;24(1):683. doi: 10.1186/s12903-024-04405-4.
Miglani A, Vishnani R, Reche A, Buldeo J, Wadher B. Hyaluronic Acid: Exploring Its Versatile Applications in Dentistry. Cureus. 2023 Oct 2;15(10):e46349. doi: 10.7759/cureus.46349. eCollection 2023 Oct.
Casale M, Moffa A, Vella P, Sabatino L, Capuano F, Salvinelli B, Lopez MA, Carinci F, Salvinelli F. Hyaluronic acid: Perspectives in dentistry. A systematic review. Int J Immunopathol Pharmacol. 2016 Dec;29(4):572-582. doi: 10.1177/0394632016652906. Epub 2016 Jun 8.
Karadas M, Cantekin K, Gumus H, Ates SM, Duymus ZY. Evaluation of the bond strength of different adhesive agents to a resin-modified calcium silicate material (TheraCal LC). Scanning. 2016 Sep;38(5):403-411. doi: 10.1002/sca.21284. Epub 2015 Nov 10.
Tao W, Tian G, Song Q, Lv Z. Application of mineral trioxide aggregate pulpotomy in the treatment of early pulpitis of primary molars. Am J Transl Res. 2024 Jan 15;16(1):285-294. doi: 10.62347/XVVC1010. eCollection 2024.
Hamdi, Mona Nagy. "Clinical and radiographic evaluation of MTA based zinc oxide eugenol versus Formocresol pulpotomy in primary molars." Egyptian Dental Journal 69.3 (2023): 1767-1773.
Sharaan, Marwa El-Sayed, and Mohamed Ibrahim Rabie. "Mineral Trioxide Aggregate VS Calcium Enriched Mixture molar pulpotomy: A systematic review and meta-analysis." Egyptian Dental Journal 64.1-January (Fixed Prosthodontics, Dental Materials, Conservative Dentistry & Endodontics) (2018): 363-371.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1222/5298
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.