NCT06611631|Not Yet RecruitingPhase 1
Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars
HA - MTA
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HA - MTA
Sponsor study identifier
interventional
34
1 country
1
Study Start
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this clinical trial is to Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars. The main question it aims to answer is: Is there a difference in the clinical or radiographic success when using Hyaluronic acid (Gengigel Teething, Ricerfarma , Italy) versus mineral trioxide aggregate (Angelus, Londrina ,Brazil) in pulpotomy of carious primary molars in children?
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
September 22, 2024
Actual (reported)September 25, 2024
Actual (reported)March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Absence of post- operative pain.
Asking the patient and/or guardian. Outcome measuring unit :Binary (present/absent)
1 week changes from baseline pulp condition
Absence of pain on percussion.
Percussion test using the back of a dental mirror. Outcome measuring unit :Binary (present/absent)
at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.
Absence of Swelling.
Visual examination. Outcome measuring unit :Binary (present/absent)
at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.
Absence of Sinus or fistula.
Visual examination. Outcome measuring unit :Binary (present/absent)
Absence of external or internal root resorption.
at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
Absence of furcation or periapical radiolucency.
at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
Absence of any adverse radiographic finding.
at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
1. After complete hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder to reach suitable consistency (1:1 ratio by volume) then gentle condensation in the pulp chamber will be done by a moistened cotton pellet and then the rest of the pulp chamber will be filled by glass ionomer restoration . 2. Tooth will be restored with stainless steel crown.
1. After complete hemostasis, MTA+ saline will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by the application of glass ionomer restoration. 2. Tooth will then be restored with stainless steel crown.
1. After complete hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder to reach suitable consistency (1:1 ratio by volume) then gentle condensation in the pulp chamber will be done by a moistened cotton pellet and then the rest of the pulp chamber will be filled by glass ionomer restoration . 2. Tooth will be restored with stainless steel crown.
Cairo University
Cairo, Egypt
Smail-Faugeron V, Fron Chabouis H, Durieux P, Attal JP, Muller-Bolla M, Courson F. Development of a core set of outcomes for randomized controlled trials with multiple outcomes--example of pulp treatments of primary teeth for extensive decay in children. PLoS One. 2013;8(1):e51908. doi: 10.1371/journal.pone.0051908. Epub 2013 Jan 3.
Chan AW, Pello A, Kitchen J, Axentiev A, Virtanen JI, Liu A, Hemminki E. Association of Trial Registration With Reporting of Primary Outcomes in Protocols and Publications. JAMA. 2017 Nov 7;318(17):1709-1711. doi: 10.1001/jama.2017.13001.
First Submitted
September 22, 2024
First Posted
September 25, 2024
Study Start
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Clinical and Radiographic Evaluation of Potassium Nitrate in Polycarboxylate Versus Mineral Trioxide Aggregate in Vital Pulpotomy in Primary Molars
at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.
Pathologic mobility
Mobility test (pressure using the end of two dental mirrors). Outcome measuring unit :Binary (present/absent)
at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.
1. After complete hemostasis, MTA+ saline will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by the application of glass ionomer restoration. 2. Tooth will then be restored with stainless steel crown.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022). Cochrane, 2022.
Camilleri J. Hydration characteristics of Biodentine and Theracal used as pulp capping materials. Dent Mater. 2014 Jul;30(7):709-15. doi: 10.1016/j.dental.2014.03.012. Epub 2014 Apr 29.
Al-Johany SS, Al Amri MD, Alsaeed S, Alalola B. Dental Implant Length and Diameter: A Proposed Classification Scheme. J Prosthodont. 2017 Apr;26(3):252-260. doi: 10.1111/jopr.12517. Epub 2016 Jul 5.
Xu X, Jha AK, Duncan RL, Jia X. Heparin-decorated, hyaluronic acid-based hydrogel particles for the controlled release of bone morphogenetic protein 2. Acta Biomater. 2011 Aug;7(8):3050-9. doi: 10.1016/j.actbio.2011.04.018. Epub 2011 Apr 24.
Cowman MK, Lee HG, Schwertfeger KL, McCarthy JB, Turley EA. The Content and Size of Hyaluronan in Biological Fluids and Tissues. Front Immunol. 2015 Jun 2;6:261. doi: 10.3389/fimmu.2015.00261. eCollection 2015.
Koray M, Ofluoglu D, Onal EA, Ozgul M, Ersev H, Yaltirik M, Tanyeri H. Efficacy of hyaluronic acid spray on swelling, pain, and trismus after surgical extraction of impacted mandibular third molars. Int J Oral Maxillofac Surg. 2014 Nov;43(11):1399-403. doi: 10.1016/j.ijom.2014.05.003. Epub 2014 Jun 10.
Romeo U, Libotte F, Palaia G, Galanakis A, Gaimari G, Tenore G, Del Vecchio A, Polimeni A. Oral soft tissue wound healing after laser surgery with or without a pool of amino acids and sodium hyaluronate: a randomized clinical study. Photomed Laser Surg. 2014 Jan;32(1):10-6. doi: 10.1089/pho.2013.3509. Epub 2013 Dec 14.
Bagio DA, Lestari NA, Putra WA, Alinda SD, Ricardo S, Julianto I. The effect of hyaluronic acid conditioned media on hDPSCs differentiation through CD44 and transforming growth factor-beta1 expressions. J Adv Pharm Technol Res. 2023 Apr-Jun;14(2):89-93. doi: 10.4103/japtr.japtr_649_22. Epub 2023 Apr 13.
Motwani N, Ikhar A, Nikhade P, Chandak M, Rathi S, Dugar M, Rajnekar R. Premixed bioceramics: A novel pulp capping agent. J Conserv Dent. 2021 Mar-Apr;24(2):124-129. doi: 10.4103/JCD.JCD_202_20. Epub 2021 Oct 9.
Cordell S, Kratunova E, Marion I, Alrayyes S, Alapati SB. A Randomized Controlled Trial Comparing the Success of Mineral Trioxide Aggregate and Ferric Sulfate as Pulpotomy Medicaments for Primary Molars. J Dent Child (Chic). 2021 May 15;88(2):120-128.
Igna A. Vital Pulp Therapy in Primary Dentition: Pulpotomy-A 100-Year Challenge. Children (Basel). 2021 Sep 24;8(10):841. doi: 10.3390/children8100841.
Guagnano R, Romano F, Defabianis P. Evaluation of Biodentine in Pulpotomies of Primary Teeth with Different Stages of Root Resorption Using a Novel Composite Outcome Score. Materials (Basel). 2021 Apr 24;14(9):2179. doi: 10.3390/ma14092179.
March 2026
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 4, 2024
Record last verified: 2024-11
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