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Comparative Clinical and Radiographic Evaluation of Hyaluronic Acid, TheraCal, and Mineral Trioxide Aggregate as Pulpotomy Agents in Primary Molars: A Randomized Clinical Trial
This randomized clinical trial aims to evaluation the clinical and radiographic outcomes of hyaluronic acid, TheraCal, and Mineral Trioxide Aggregate (MTA) when used as pulpotomy agents in primary molars. 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?
Premature loss of primary teeth can affect occlusion development and lead to complications such as space loss and malalignment of permanent teeth. To prevent this, effective pulpotomy treatment is essential. Therefore, identifying the most suitable pulpotomy agent is crucial to retain primary teeth until their natural exfoliation. 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.
Age
4 - 8 years
Sex
ALL
Healthy Volunteers
No
Al-Azhar University
Cairo, Egypt
Start Date
October 1, 2025
Primary Completion Date
October 1, 2026
Completion Date
November 1, 2026
Last Updated
September 11, 2025
66
ESTIMATED participants
Hyaluronic Acid (HA)
PROCEDURE
TheraCal
PROCEDURE
Mineral Trioxide Aggregate
PROCEDURE
Dr. Adel Fathy Hussein, Professor
CONTACT
Lead Sponsor
Al-Azhar University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07008599