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| Name | Class |
|---|---|
| Alexandria University | OTHER |
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The aim of this study is to evaluate and compare the clinical effectiveness of 38% silver diamine fluoride with and without potassium iodide with that of resin modified glass ionomer cement in indirect pulp capping of young permanent molars.
A sample of children with an age range of 6-9 years, having a first permanent molar erupted with deep occlusal carious lesion, will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. All selected 108 first permanent molars will be randomly equally allocated into three groups according to capping material used. Group I (n=36) SDF/ KI and Group II (n=36) SDF and Group III (n=36) Glass ionomer cement. Indirect pulp capping treatment procedure will be performed with identical protocols except for the capping material to be used and its application will be according to manufacturer's instructions. Glass ionomer cement will be used as a base and resin-based composite restoration will be used in the three groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silver diamine fluoride/ potassium iodide group | Experimental | Riva Star Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia |
|
| Silver diamine fluoride group | Experimental | Advantage arrest TM, Elevate Oral Care, USA |
|
| Resin modified glass ionomer cement group | Active Comparator | Riva light cure, SDI, Bayswater, Australia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver diamine fluoride/ potassium iodide | Drug | Thirty six first permanent molars will receive 38% SDF/KI as an indirect pulp capping material. |
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no). (American Academy of Pediatric Dentistry. 2019) | 6 months |
| Postoperative pain | Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no). (American Academy of Pediatric Dentistry. 2019) | 12 months |
| Tooth Vitality | Tooth vitality will be assessed by vitality test using thermal stimulation, binary (yes or no). (American Academy of Pediatric Dentistry. 2019) | 6 months |
| Tooth Vitality | Tooth vitality will be assessed by vitality test using thermal stimulation, binary (yes or no). (American Academy of Pediatric Dentistry. 2019) | 12 months |
| Success of the restoration | Clinical success of the whole restoration will be ranked according to Modified Ryge/USPHS Clinical Criteria (Colour, marginal adaptability, marginal staining, and secondary caries). (Moncada G, Silva F, Angel P, Oliveira Jr O, Fresno MC, Cisternas P, et al. 2014) | 6 months |
| Success of the restoration | Clinical success of the whole restoration will be ranked according to Modified Ryge/USPHS Clinical Criteria (Colour, marginal adaptability, marginal staining, and secondary caries). (Moncada G, Silva F, Angel P, Oliveira Jr O, Fresno MC, Cisternas P, et al. 2014) | 12 months |
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Inclusion Criteria:
For children:
For first permanent molars:
Exclusion Criteria:
For children:
For first permanent molars:
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| Name | Affiliation | Role |
|---|---|---|
| Marwa Baraka, M.Sc | Faculty of Dentistry, Alexandria University, Egypt | Principal Investigator |
| Magda El-Tekeya, PhD | Faculty of Dentistry, Alexandria University, Egypt | Study Chair |
| Niveen Bakry, PhD | Faculty of Dentistry, Alexandria University, Egypt | Study Chair |
| Fontana Margherita | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | 21512 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17555173 | Background | Ekstrand KR, Martignon S, Ricketts DJ, Qvist V. Detection and activity assessment of primary coronal caries lesions: a methodologic study. Oper Dent. 2007 May-Jun;32(3):225-35. doi: 10.2341/06-63. | |
| 28955548 | Background | Dikmen B. Icdas II criteria (international caries detection and assessment system). J Istanb Univ Fac Dent. 2015 Oct 21;49(3):63-72. doi: 10.17096/jiufd.38691. eCollection 2015. |
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| ID | Term |
|---|---|
| D003809 | Dentin, Secondary |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C024633 | silver diamine fluoride |
| D011193 | Potassium Iodide |
| ID | Term |
|---|---|
| D007454 | Iodides |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D017680 | Potassium Compounds |
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This is a 3 arm clinical trial. All selected first permanent molars will be randomly equally allocated into three groups according to capping material used.
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Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).
|
| Silver diamine fluoride | Drug | Thirty six first permanent molars will receive 38% SDF as an indirect pulp capping material. |
|
|
| Resin modified glass ionomer cement | Drug | Thirty six first permanent molars will receive RMGIC as an indirect pulp capping material. |
|
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| Radiographic evaluation or root lengthening | Root lengthening will be assessed by measuring the root length in mm from cement-enamel junction on standardized digital radiographs taken by parallel technique (digora software). (Flake NM, Gibbs JL, Khan AA. 2014) | 6 months |
| Radiographic evaluation or root lengthening | Root lengthening will be assessed by measuring the root length in mm from cement-enamel junction on standardized digital radiographs taken by parallel technique (digora software). (Flake NM, Gibbs JL, Khan AA. 2014) | 12 months |
| Radiographic evaluation of reparative dentin formation | Reparative dentin formation, if present, will be measured in millimetre on standardized digital radiographs taken by parallel technique (digora software). (Menon NP, Varma BR, Janardhanan S, Kumaran P, Xavier AM, 2016) | 6 months |
| Radiographic evaluation of reparative dentin formation | Reparative dentin formation, if present, will be measured in millimetre on standardized digital radiographs taken by parallel technique (digora software). (Menon NP, Varma BR, Janardhanan S, Kumaran P, Xavier AM, 2016) | 12 months |
| Radiographic evaluation of reparative dentin volume | This was measured using cone beam computed Tomography (CBCT). Reparative dentin radiodensity will be measured in Hounsfield units (HU). (Mathur VP, Dhillon JK, Logani A, Kalra G. 2016) | 12 months |
| 29070149 | Background | Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, Fontana M, Graham L. Use of Silver Diamine Fluoride for Dental Caries Management in Children and Adolescents, Including Those with Special Health Care Needs. Pediatr Dent. 2017 Sep 15;39(5):135-145. |
| 27931467 | Background | Guideline on Pulp Therapy for Primary and Immature Permanent Teeth. Pediatr Dent. 2016 Oct;38(6):280-288. No abstract available. |
| 36878216 | Derived | Baraka MMAL, Cevidanes L, Tekeya M, Bakry N, Ruellas A, Botero T, Benavides E, Fontana M. Three-Dimensional Assessment of Radiographic Changes after Indirect Pulp Capping Using Silver Diamine Fluoride with or without Potassium Iodide in Young Permanent Teeth (12-Month RCT). Caries Res. 2023;57(2):177-188. doi: 10.1159/000529893. Epub 2023 Mar 6. |
| 36253166 | Derived | Baraka M, Tekeya M, Bakry NS, Fontana M. Twelve-month randomized controlled trial of 38% silver diamine fluoride with or without potassium iodide in indirect pulp capping of young permanent molars. J Am Dent Assoc. 2022 Dec;153(12):1121-1133.e1. doi: 10.1016/j.adaj.2022.08.008. Epub 2022 Oct 15. |