Comparison of Hyaluronic Acid, TheraCal, and Mineral Trioxide Aggregate as Pulpotomy Agents in Primary Molars

NCT07168811 | Not Yet Recruiting

• 1 other identifier: 1222/5298
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Pulpotomies Primary Teeth; Pulp Disease, Dental

Keywords

Hyaluronic Acid; TheraCal; MTA

Outcome Measures

Primary Outcomes (2)

• Clinical evaluation

  Clinical evaluation: Absence of * Pain * Soft tissue swelling * Sinus tract * tenderness to percussion * tooth mobility

  3, 6, and 12 months.

• Radiographic evaluation

  Conventional radiographic evaluation: absence of * Internal resorption. * External resorption. * Periapical or furcation RL. * Obliteration pulp calcification. * Widening of periodontal space.

  3, 6, and 12 months

Study Arms (3)

Hyaluronic acid

EXPERIMENTAL

• 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).

Procedure: Hyaluronic Acid (HA)

TheraCal

EXPERIMENTAL

• 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).

Procedure: TheraCal

Mineral Trioxide Aggregate

ACTIVE COMPARATOR

• 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).

Procedure: Mineral Trioxide Aggregate

Interventions

Hyaluronic Acid (HA) PROCEDURE

• 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)

Also known as: HA Pulpotomy

Hyaluronic acid

TheraCal PROCEDURE

• 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)

Also known as: TheraCal LC Pulpotomy

TheraCal

Mineral Trioxide Aggregate PROCEDURE

• 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)

Also known as: MTA Pulpotomy

Mineral Trioxide Aggregate

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 4-8 years,
• 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).

You may not qualify if:

• Swelling, sinus tract, or fistula.
• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Cairo, Egypt

Location

Related Publications (14)

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 39176161 BACKGROUND

• 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.

  PMID: 38078039 BACKGROUND

• 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.

  PMID: 34752723 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 38867194 BACKGROUND

• 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.

  PMID: 37920632 BACKGROUND

• 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.

  PMID: 27280412 BACKGROUND

• 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.

  PMID: 26553783 BACKGROUND

• 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.

  PMID: 38322556 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Hyaluronic Acid; TheraCal; mineral trioxide aggregate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Omaima Salah Elbeltagy

CONTACT

00201159514617; Elbeltagyomaima@gmail.com

Dr. Adel Fathy Hussein, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Operator Blinding: The operator performing the procedure will not be blinded due to the differences in handling and appearance of the materials. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 1. Group I: Hyaluronic acid (0,5% gengigel teething). (Study group). 2. Group II: theraCal LC. (Study group). 3. Group III: MTA (Control group).

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

EG (1)