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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?
Preservation of primary dentition decreases the risk of developing any occlusal abnormalities caused by premature loss of primary teeth, which are considered natural space maintainers for the successor permanent teeth, therefore vital pulp therapy is of a big concern in the research field in pediatric dentistry.
One of the most commonly used regenerative materials in pulpotomies is Mineral Trioxide Aggregate (MTA) which showed a high success rate clinically and radiographically when compared to other materials due to its biocompatibility, antibacterial properties and excellent sealing ability . However it has some drawbacks such as difficult manipulation and handling because it is supplied in powder and liquid form which need mixing. Mixing is operator dependent and may be not uniform if handled wrongly, technique sensitive, potential discoloration, and long setting time.
Hyaluronic acid have been introduced as a new biologically based therapeutics directed at preserving pulp vitality. Owing to good handling characteristics, biocompatibility, odontogenic property. non-toxic, biodegradable ,non-immunogenic , anti-inflammatory and antibacterial action, hyaluronic acid is a promising pulpotomy agent Furthermore, the use of a gel containing HA facilitated faster healing in laser-induced wounds by secondary intention. HA tends to be helpful in the treatment of swelling and trismus as well as the inflammatory reaction after third molar extraction.
The benefits of this study to the participants:
A cheaper , faster and easier clinical procedure leads to a more efficient dental treatment, which could develop positive attitude of children towards dentistry.
The benefits of this study to the population:
The benefits of this study to the clinicians:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid Pulpotmoy | Experimental |
|
|
| Mineral Trioxide Aggregate | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid pulpotomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of external or internal root resorption. | Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent) | 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. |
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Inclusion Criteria:
Aged 4-8 years, in good general health and medically within normal.
Teeth:
Pre-operative Radiographic criteria:
Exclusion Criteria:
Patients:
Teeth:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadeer Nasser Aboeldahb, Doctor | Contact | 00201060485554 | hadeer.nasser@dentistry.cu.edu.eg | |
| yasmin mohammed yossury, Ass.Prof | Contact | yasmin.yousry@dentistry.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23300955 | Background | 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. | |
| 28892118 |
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|
|
| mineral trioxide aggregate pulpotomy | Procedure |
|
|
|
Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent) |
| 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. | Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent) | at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month. |
| 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. |
| 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. |
| 24793199 | 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. |
| 27379723 | 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. |
| 21550426 | 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. |
| 26082778 | 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. |
| 24924267 | 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. |
| 24328847 | 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. |
| 37255878 | 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. |
| 34759576 | 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. |
| 34321144 | 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. |
| 34682106 | 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. |
| 33923152 | 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. |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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