Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars

NCT06611631 | Not Yet Recruiting Phase 1

• 1 other identifier: HA Pulpotomy
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Pulpotomies Primary Teeth; Pulp Disease, Dental

Keywords

hyaluronic acid; HA; MTA; Mineral Trioxide Aggregate

Outcome Measures

Primary Outcomes (5)

• 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)

  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.

Secondary Outcomes (3)

• 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.

Study Arms (2)

Hyaluronic Acid Pulpotmoy

EXPERIMENTAL

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.

Procedure: Hyaluronic acid pulpotomy

Mineral Trioxide Aggregate

ACTIVE COMPARATOR

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.

Procedure: mineral trioxide aggregate pulpotomy

Interventions

Hyaluronic acid pulpotomy PROCEDURE

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.

Also known as: HA pulpotomy

Hyaluronic Acid Pulpotmoy

mineral trioxide aggregate pulpotomy PROCEDURE

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.

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:

• Patients:
• Aged 4-8 years, in good general health and medically within normal.
• Teeth:
• Restorable mandibular primary molars.
• History of reversible pulpitis.
• Pre-operative Radiographic criteria:
• Absence of periapical or inter-radicular radiolucencies.
• Absence of widening of periodontal ligaments (PDL) space.
• Absence of internal or external root resorption.

You may not qualify if:

• Patients:
• With systemic disorders.
• Physical or mental disabilities.
• Unable to attend follow- up visits.
• Refusal of Participation.
• Refusal to sign the informed consent.
• Teeth:
• Previously accessed teeth.
• Mobile mandibular primary molars.
• Swelling in the vestibule or on palpation.
• Pain on percussion

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (14)

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  PMID: 23300955 BACKGROUND

• 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.

  PMID: 28892118 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24793199 BACKGROUND

• 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.

  PMID: 27379723 BACKGROUND

• 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.

  PMID: 21550426 BACKGROUND

• 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.

  PMID: 26082778 BACKGROUND

• 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.

  PMID: 24924267 BACKGROUND

• 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.

  PMID: 24328847 BACKGROUND

• 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.

  PMID: 37255878 BACKGROUND

• 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.

  PMID: 34759576 BACKGROUND

• 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.

  PMID: 34321144 BACKGROUND

• 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.

  PMID: 34682106 BACKGROUND

• 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.

  PMID: 33923152 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Hadeer Nasser Aboeldahb, Doctor

CONTACT

00201060485554; hadeer.nasser@dentistry.cu.edu.eg

yasmin mohammed yossury, Ass.Prof

CONTACT

yasmin.yousry@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Resident

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)