Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars (a Randomized Controlled Clinical Trial)

Conditions
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Tertiary Dentine, Indirect Pulp Capping

Intervention / Treatment
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* Drug: Silver diamine fluoride/ potassium iodide
* Drug: Silver diamine fluoride
* Drug: Resin modified glass ionomer cement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For children: Children who are generally healthy. Children having a deep dentin carious lesion in a permanent first molar (upper or lower). Parents signed informed consent. For first permanent molars: Cavitated class I carious lesions with opaque or discolored enamel exposing the dentin beneath corresponding to ICDAS II score 5 and 6 (visible dentin). (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007) Teeth having lesions that are considered active according to ICDAS II activity criteria for primary coronal caries. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015) Immature with open apex as revealed by periapical X-ray. Exclusion Criteria: For children: Any allergy reported by the parents. (Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, et al. 2017) Children unable to return for recall visits. For first permanent molars: Any clinical signs of irreversible pulpitis (spontaneous pain, pain on percussion, abscess, sinus. Any radiographic sign of irreversible pulp pathologies or necrosis periapical radiolucency, internal or external root resorption). Teeth with inactive lesions. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver diamine fluoride/ potassium iodide group<br>Riva Star Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia | Drug: Silver diamine fluoride/ potassium iodide<br>* Thirty six first permanent molars will receive 38% SDF/KI as an indirect pulp capping material.<br>* Other names: SDF/KI;|
| Experimental: Silver diamine fluoride group<br>Advantage arrest TM, Elevate Oral Care, USA | Drug: Silver diamine fluoride<br>* Thirty six first permanent molars will receive 38% SDF as an indirect pulp capping material.<br>* Other names: SDF;|
| Active Comparator: Resin modified glass ionomer cement group<br>Riva light cure, SDI, Bayswater, Australia | Drug: Resin modified glass ionomer cement<br>* Thirty six first permanent molars will receive RMGIC as an indirect pulp capping material.<br>* Other names: RMGIC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silver diamine fluoride/ potassium iodide, glass ionomer cement