Pulpotomies Primary TeethNCT07168811
Comparison of Hyaluronic Acid, TheraCal, and Mineral Trioxide Aggregate as Pulpotomy Agents in Primary Molars
A study testing Hyaluronic Acid (HA), TheraCal and Mineral Trioxide Aggregate in people with Pulpotomies Primary Teeth and Pulp Disease, Dental, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Pulpotomies Primary Teeth, Pulp Disease, Dental
- What is being tested?
- Hyaluronic Acid (HA), TheraCal and Mineral Trioxide Aggregate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 10Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Adel Fathy Hussein, Professor contact
About this study
Official title: 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?
Read the detailed description
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.
- Conditions
- Pulpotomies Primary Teeth, Pulp Disease, Dental
- Being tested
- Hyaluronic Acid (HA), TheraCal, Mineral Trioxide Aggregate
- Keywords
- Hyaluronic Acid, TheraCal, MTA
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid (HA)Procedure or surgery
Also called HA Pulpotomy
- 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)
TheraCalProcedure or surgery
Also called TheraCal LC Pulpotomy
- 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)
Mineral Trioxide AggregateProcedure or surgery
Also called MTA Pulpotomy
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Procedure: Mineral Trioxide Aggregate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation
Clinical evaluation:
Absence of
- Pain
- Soft tissue swelling
- Sinus tract
- tenderness to percussion
- tooth mobility
Measured: 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.
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pulpotomies Primary TeethStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Group I: Hyaluronic acid (0,5% gengigel teething). (Study group). 2. Group II: theraCal LC. (Study group). 3. Group III: MTA (Control group).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omaima Salah Ahmed Mohamed Elbeltagy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168811
- Sponsor's protocol ID
- 1222/5298
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39176161Jha 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.
PubMed 38078039Ildes 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.
PubMed 34752723Shaimaa 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.
PubMed 38867194Miglani 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.
PubMed 37920632Casale 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.
PubMed 27280412Karadas 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.
PubMed 26553783Tao 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.
PubMed 38322556Hamdi, 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical and Radiographic Evaluation of Hyaluronic Acid, TheraCal, and Mineral Trioxide Aggregate as Pulpotomy Agents in Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07168811
- Acronym / sponsor ID
- 1222/5298
- Conditions
- Pulpotomies Primary Teeth, Pulp Disease, Dental
- Keywords
- Hyaluronic Acid, TheraCal, MTA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 1. Group I: Hyaluronic acid (0,5% gengigel teething). (Study group). 2. Group II: theraCal LC. (Study group). 3. Group III: MTA (Control group).
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Experimental | Procedure: Hyaluronic Acid (HA)• 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). |
| TheraCal | Experimental | Procedure: 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). |
| Mineral Trioxide Aggregate | Active comparator | Procedure: 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). |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- Swelling, sinus tract, or fistula.
- Spontaneous pain.
- Necrotic pulp, pathological mobility.
- Cases require for general anesthesia.
- A history of repeated need for analgesics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic Acid (HA)Also: HA Pulpotomy• 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) | Procedure or surgery | Hyaluronic acid |
| TheraCalAlso: TheraCal LC Pulpotomy• 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) | Procedure or surgery | TheraCal |
| Mineral Trioxide AggregateAlso: MTA Pulpotomy• 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) | Procedure or surgery | Mineral Trioxide Aggregate |
Primary outcome
Clinical evaluation
Time frame: 3, 6, and 12 months.
Clinical evaluation: Absence of * Pain * Soft tissue swelling * Sinus tract * tenderness to percussion * tooth mobility
Radiographic evaluation
Time frame: 3, 6, and 12 months
Conventional radiographic evaluation: absence of * Internal resorption. * External resorption. * Periapical or furcation RL. * Obliteration pulp calcification. * Widening of periodontal space.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- BackgroundCameron, 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.
- BackgroundKhatab, 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: PubMed 39176161Amrollahi 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.
- Background: PubMed 38078039Jha 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.
- Background: PubMed 34752723Ildes 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.
- BackgroundShaimaa 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
- BackgroundVerma, 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: PubMed 38867194Sezgin 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.
- Background: PubMed 37920632Miglani 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.
- Background: PubMed 27280412Casale 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.
- Background: PubMed 26553783Karadas 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.
- Background: PubMed 38322556Tao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Adel Fathy Hussein, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid (HA), TheraCal and Mineral Trioxide Aggregate in people with Pulpotomies Primary Teeth and Pulp Disease, Dental, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omaima Salah Elbeltagy (00201159514617, Elbeltagyomaima@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation (time frame: 3, 6, and 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07168811, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.